Structure and Dynamics of Health Research and Public Funding: An International Institutional Comparison

STRUCTURE AND DYNAMICS OF HEALTH RESEARCH AND PUBLIC FUNDING

DIETMAR BRAUN Institute of Political Science, University of Heidelberg, Germany

STRUCTURE AND DYNAMICS OF HEALTH RESEARCH AND PUBLIC FUNDING An International Institutional Comparison

kJ

m KLUWER ACADEMIC PUBLISHERS DORDRECHT / BOSTON / LONDON

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ISBN 0-7923-2777-2

Published by Kluwer Academic Publishers, P.O. Box 17, 3300 AA Dordrecht, The Netherlands. Kluwer Academic Publishers incorporates the publishing programmes of D. Reidel, Martinus Nijhoff, Dr W. Junk and MTP Press. Sold and distributed in the U.S.A. and Canada by Kluwer Academic Publishers, 101 Philip Drive, Norwell, MA 02061, U.S.A. In all other countries, sold and distributed by Kluwer Academic Publishers Group, P.O. Box 322, 3300 AH Dordrecht, The Netherlands.

This book was translated by Neil Solomon This work was promoted by the German Federal Ministry for Research and Technology, reference 01 ZZ 8801/3

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CONTENTS

1. INTRODUCTION

1 PARTI

2. DIMENSIONS OF HEALTH RESEARCH

11

2.1

BIOMEDICAL RESEARCH

11

2.2.

PUBLIC HEALTH RESEARCH

15

3. DYNAMICS OF HEALTH RESEARCH

19

PART 2 4. BASIC PROBLEMS BESETTING CLINICAL RESEARCH

4.1

27

DIFFERENTIATION TENDENCIES EMERGING FROM THE SOCIAL ORGANIZATION OF SCIENCE AND MEDICINE . . .

29

4.1.1 Divergent Cognitive Perceptions as a Dissociating Element

30

4.1.2 Credibility Cycles as a Dissociating Element

32

4.1.3 Institutional Incentives as a Dissociating Mechanism . . .

33

4.1.4 Increasing Complexity as a Dissociating Element

34

4.2

AN INTERNATIONAL COMPARISON OF THE INSTITUTIONAL CONDITIONS OF CLINICAL RESEARCH

36

VI

4.2.1 Explaining Variations in the Role of Clinical Research (I): Differences in the Models of Association Linking Hospitals and Medical Schools

36

4.2.2 Explaining Variations in the Role of (Clinical) Research (II): The Full-Time System 46 4.2.3 Explaining Variations in the Role of (Clinical) Research (III): Differences in the Decision-Making Structures of Medical Departments and Hospitals

52

4.3

58

CONCLUSION

PART 3 5. AN INTERNATIONAL COMPARISON OF HEALTH FUNDING SYSTEMS 65 5.1

GENERAL CHARACTERISTICS OF FUNDING SYSTEMS IN HEALTH RESEARCH

67

5.2

THE SCOPE OF INFLUENCE OF FUNDING

81

5.3

PRELIMINARY CONCLUSIONS REGARDING THE SCOPE OF INFLUENCE OF FUNDING AGENCIES

88

THE ROLE OF POLITICS AND SCIENCE IN FUNDING POLICY AND FUNDING PROCEDURES

90

5.4.1 Forms of Coordination Between Funding Organizations and Political Creditors

92

5.4.2 The Role of Science Within Funding Organizations . .

104

5.4

5.5

CONCLUSION CONCERNING THE INFLUENCE OF POLITICAL AND SCIENTINC INTERESTS ON STRATEGIES OF FUNDING AGENCIES

112

Vll

6. A COMPARISON OF THE RANGE AND PROBLEM-SOLVING ABILITIES OF DIFFERENT SETS OF FUNDING INSTRUMENTS 121 6.1

6.2

THE ADVANTAGES AND DISADVANTAGES OF HAVING AN INTRAMURAL COMPONENT TO RESEARCH FUNDING . . .

121

THE RANGE OF THE SET OF FUNDING INSTRUMENTS IN HEALTH RESEARCH

126

6.2.1 Ensuring the Basic Preconditions of Research

127

6.2.2 Measures in the Field of Human Capital

129

6.2.3 Measures for Influencing Thematic Orientation and Eliminating Institutional Rigidities

132

6.2.4 The Problem-Solving Abilities of the Set of Funding Instruments Applied to Clinical Research

135

6.3

FUNDING MEASURES: SOME CONCLUSIONS

145

PART 4 7. PROBLEMS OF PUBLIC HEALTH RESEARCH

7.1

7.2

7.3

THE INTERDISCIPLINARY HEALTH

CHARACTER

OF

151

PUBLIC 153

THE COMPETITION BETWEEN MEDICINE AND PUBLIC HEALTH

156

THE ROLE OF POLITICAL RESEARCH FUNDING

160

7.3.1 The Funding of Public Health Research by Health Ministries

161

7.3.2 The Funding of Public Health Research by the Funding-Agencies

173

7.4

CONCLUSIONS CONCERNING PUBLIC HEALTH

176

Vlll

8. CONCLUSIONS: THE FUNDING OF HEALTH RESEARCH

181

LITERATURE

193

IX

LIST OF FIGURES

Figure 1: Figure 2:

Figure 3:

Typology of decision-making structures in medical schools

50

Funds expended on biosciences in 1987 per 1000 inhabitants in selected countries (in US dollars)

81

A comparison of the scope of the formative powers of funding organizations

88

LIST OF TABLES

Table 1: Table 2: Table 3: Table 4:

The research process in natural-science-oriented, clinical research

13

An overview of favorable institutional conditions for clinical research

57

The financing of research and development in four countries

65

Degree of political agencies

91

influence

in funding

XI

GLOSSARY

ABRC

Advisory Board of Research Councils (Great Britain)

ADAMHA

Alcohol, Drug Abuse and Mental Health Administration (U.S.)

AFRC

Agricultural and Food Research Council (Great Britain)

AHCP

Agency for Health Care Policy and Research (U.S.)

AMA

American Medical Association (U.S.)

AMRC

Association of Medical Research Charities (Great Britain)

ANRS

Agence Nationale de Recherche sur le SIDA (at INSERM; France)

APHS

Association of Public Health Schools (U.S.)

BMFT

Bundesministerium

fiir

Forschung

und

Technologie

(Germany); Ministry for Research and Technology CDC

Centers of Disease Control (U.S.)

CHU

Centres Hospitalifers Universitaires (France);

CNRS

Centre National de la Recherche Scientifique (France)

CODIS

College de direction scientifique (at INSERM; France)

CRC

Clinical Research Centre (at MRC; Great Britain)

CRCa

Cancer Research Campaign (Great Britain)

CS

Conseil Scientifique (at INSERM; France)

Xll

CSS

Commissions Scientifiques Sp6cialis6es (at INSERM; France)

DES

Department of Education and Science (Great Britain)

DFG

Deutsche Forschungsgemeinschaft

(Germany); German

Research Community DHHS

Department of Health and Human Service (U.S.)

DHSS

Department of Health and Social Security (Great Britain)

DoH

Department of Health (Great Britain)

ESRC

Economic and Social Research Council (Great Britain)

ICRF

Imperial Cancer Research Funds (Great Britain)

INSERM MRC

Institut National de la Sant6 et de la Recherche M6dicale (France) Medical Research Council (Great Britain)

NCI

National Cancer Institute (NIH; U.S.)

NHLBI

National Heart, Lung and Blood Institute (NIH; U.S.)

NHS

National Health Service (Great Britain)

NIAID

National Institute of Allergy and Infections Diseases (NIH; U.S.)

NIH

National Institutes of Health (U.S.)

NSF

National Science Foundation (U.S.)

RLG

Research Liaison Groups (Great Britain)

UFC

University Funding Council (Great Britain)

WT

Wellcome Trust (Great Britain)

1.

INTRODUCTION

There is no doubt that health is one of the most highly esteemed goods the world over. The fruits of research into the mysteries of the human body and into the social and environmental factors causing diseases have improved the life expectancy of millions of people. Still, morbidity and mortality rates have remained high. This has to be attributed to the rise of chronic diseases, such as cancer and cardiovascular diseases, which have more than outweighed the success in combating infectious diseases attained in this century. Though health research has been successful in raising the chances of survival for those beset by any of these diseases, it has yet to find more effective remedies. Many questions remain unanswered. In this situation investments in health research remain a viable strategy for governments interested in underscoring their commitment to the health of the general population. Since the Second World War health research funding has become one of the major activities of research policy-making of Western governments, especially in the United States. There is no doubt that the injection of public ftinds into medical schools and medical departments has created one of the largest research communities in science and has drawn the attention of many a biomedical scientist and clinician into areas of relevance for the health of the general population. Despite all the efforts of biomedical scientists, clinicians, public health experts, sponsors and policymakers, there are two problems that elicit dissatisfaction either among researchers or among sponsors and politicians: The biomedical research community voices its discontent with the shortage in public funding caused by the government austerity programs generally found in most Western countries since the 1980s. In addition, there are frequent complaints about institutional research conditions detrimental to a productive health-research enterprise and about the uncooperative attitudes of clinicians and preclinical researchers. At a time when molecular biology appears to harbor immense curative potential and life-style and environment are proven causes of illness, interdisciplinary research bridging the gap between preclinical and clinical advances, and between clinical and socialscientific knowledge is a prerequisite for enhancing our knowledge of disease and health and for finding remedies for the multitude of diseases still haunting mankind. This turns a lack of institutional conditions for interdisciplinary research and hostile attitudes toward cooperative efforts into

Health Research and Its Funding

a challenge for all actors responsible for the development and application of health research. It is my intention in this book, therefore, first, to describe and provide explanations for the deficient structures and attitudes in health research in the four countries commonly regarded as the most advanced in research (England,^ the Federal Republic of Germany, France, and the United States), and secondly, to comparatively assess what funding agencies, as one of the most important actors in health research in these countries, have done and can do to ameliorate institutional rigidities and uncooperative behavior in health research. This book will place particular emphasis on two research areas. For as the experts whom I interviewed in the course of my study plainly indicated though there are national differences (as I will show) - clinical research and public health research are the pivotal areas in health research that obviously seem to be malftinctioning today: Clinical research is the activity responsible for translating knowledge derived from basic biomedical research into knowledge which can be exploited for the benefit of patients. If clinicians do not come to terms with the advances made by molecular biologists, the application of biomedical findings is doomed. It is argued in this study that cognitive discrepancies between clinicians and scientists, mechanisms of social closure of the scientific and health care subsystems, and organizational features inherent to medical schools and hospitals inhibit or at the least retard the transfer of biomedical knowledge into clinical application in most countries. Public health research translates findings from both biomedical or clinical research and from epidemiology and the social-scientific research into population-based interventional strategies. It can be demonstrated that the scientific expertise of public health is both highly fragmented and, in many instances, still in an exploratory stage of cognitive development. Explanatory factors for these shortcomings include the reluctance of clinical and

This report covers not the whole part of Great Britain but is confined to England and Wales, which were subject to the same political structures in research policy until 1991. Scotland and Northern Ireland, on the other hand, differ from England and Wales in aspects of both political structure and research policy. Time constraints made it impossible to incorporate these differences within the book. Thus, any reference to England in the following refers to England and Wales.

Introduction

biomedical departments to cooperate with public health scientists, social barriers to interdisciplinary research, and politicians' use of public health research for their own short-term purposes. While these deficiences are apparently found in many Western countries,^ there are differences in the intensity of ttiese problems and in the likelihood that research funding will be able to eliminate them. A primary distinction is found between research performance in the United States, on the one hand, and in the three European countries, on the other. The effort to discover the major explanatory factors for these differences will involve a detailed assessment of three levels of observation:

• First, a description of nationally specific institutional and organizational structures at the level of clinical research and public health; • Secondly, an account of the institutions, organizations, and instruments on the level of research funding; and • Thirdly, an international comparison of the interaction between policymakers, funding agencies, and scientific actors in the funding of health research. Social processes, institutional peculiarities, and the interaction of selfinterested (corporate) actors lie at the heart of this study's explanation of deficiencies in health research. The analysis presented here intends to improve, by comparison, existing knowledge on the functioning of health research and on feasible funding strategies for removing structural barriers in the organization of health research that impede the smooth transfer of basic knowledge into applications in the health care system. In this sense, it is a study in the tradition of comparative public policy analysis. In this tradition the book endeavors to provide new knowledge in three ways: • By exploring a policy area that has not been given its due up until now in the literature on public policies, i.e., health research policy.

Talks I have had with Japanese and Swiss health researchers and governmental sponsors indicated that they face the same difficulties in developing clinical and public health research that I have found in the four countries investigated.

Health Research and Its Funding

• By investigating the structures, dynamics, and interrelationships of two subsystems (the scientific and health-care subsystems) that affect the capacities of policymakers and funding agencies to improve health research. • By supplying knowledge on a set of corporate actors, the funding agencies, which are of utmost importance for research policies in most countries, but which have seldom been subject to the debate of public policy researchers (for an exception, see: OECD 1991; Irvine et. al. 1990). By discussing the strategies and instrumental capabilities of ftinding agencies, the study endeavors to contribute to a more profound knowledge of the functioning of intermediary agencies that are located between the political system and societal subsystems. In Part 1, the study begins with a short exploration of the empirical field. What are we talking about when we speak of "clinical research" or "public health research" (chapter 2)? What are the premises and goals of these research traditions? Chapter 3 is then dedicated to a discussion of the current dynamics and challenges in health research which give rise to problemsolving efforts in clinical and public health research. In Part 2,1 discuss the shortcomings of clinical research by pointing first to the overall tendencies of differentiation between the respective roles of practically oriented and more research-minded clinicians as well as between the respective roles of preclinical and clinical academics at medical schools (section 4.1). Divergencies in experiential horizon, the centrifugal forces of credibility cycles, and the increasing complexity of scientific research all contribute to these tendencies toward differentiation. Secondly, the differences in the institutional outlook of the four countries are presented. The main focus of this section (sec. 4.2) is placed on the seemingly better performance of health research in the United States as compared to the European experience. Institutional factors which can account for variations include the models of association linking hospitals and medical schools (sec. 4.2.1), the way in which medical schools deal with the private practice of clinicians (sec. 4.2.2), and university decision-making structures (sec. 4.2.3). Part 3 deals extensively with the role of funding agencies in health research. It is my contention that funding agencies are the main actors with both the instruments and the experience to improve deficiencies in health research. What kind of funding agencies and instruments are needed,

Introduction

however, to take care of clinical research? By way of a comparison of the four health funding systems, it is demonstrated that those funding agencies with sufficient funding resources, a high demand for resources on the part of researchers, a monopolistic position in the funding system, and a dynamic equilibrium between the influence exercised by policymakers on the one hand, and scientists, on the other, on strategy building within the funding agency are very likely to contribute to positive changes in health research (chap. 5). Chapter 6 turns to the instrumental opportunities available to funding organizations. The central focus of the chapter is placed on the differences in the range covered by, and the problem-solving ability of, the various instrument sets implemented by funding agencies in dealing with the structural problems of clinical research. Finally, in Part 4, we turn to the deficiencies in public health research. Though again we find differences between the United States and the European countries in the productivity and innovativeness of research performance, public health in all the countries investigated is beset by a high degree of fragmentation in cognitive fields, research approaches, and interests. In addition, it can also be shown that public health has not experienced an upswing in research activities similar to that of the biomedical sciences because its status in society, in science, and among funding agencies is low. Public health has not been able to develop the institutional autonomy which could have triggered the financial support necessary for a more promising establishment of its scientific base. Politics has a part in this, since in all the countries studied governments have used public health experts for short-term and application-oriented research for the sake of their own interests. This has distracted most intellectual resources from developing a unifying paradigm. In this way, the challenges for public health may linger on for quite some time, despite a remarkable change in government attitudes in the aftermath of AIDS that has led to more generous support for basic science centers. The final chapter provides a summary of the general assets and liabilities of the instrument of funding in healtih research. In the course of this presentation it becomes cleartihatthe potential powers of this instrument are less a function of its instrumental features and more a function of the different conditions under which it is implemented in the various funding and research systems.

This page intentionally blank

Health Research and Its Funding

This book is the synopsis of a more detailed comparison of health research and its funding systems in the United States, England, France, and Germany that I have worked on since 1989. The research project, which was started in February 1989 at the Max Planck Institute for Research on Society ("Max-Planck-Institut fur Gesellschaftsforschung") in Cologne, Germany, was financed by the German Ministry of Research and Technology in the framework of its federal program on "Research and Development in the Service of Health." In order to understand the structures, dynamics, and problems of health research and its funding systems in the four countries, interviews with numerous experts from funding agencies and with biomedical scientists, clinical researchers, public health experts, and administrators at research institutions were held in each country. The interviews represent the primary empirical basis that I have used for interpretation. This inside knowledge of experts was supplemented by literature available on this topic.^ The detailed English versions of the national studies on the United States, England, France, and Germany (translated by Neil Solomon and quoted as Braun 1993a, Volume 1 [Germany and United States] and Volume 2 [France and England]) are available from the author upon request. Neil Solomon translated the manuscript of this book from German into English in close cooperation with me. Of course, I take full responsibility of the text presented here. Acknowledgments Numerous individuals have assisted me in a variety of ways during my research on health research and its funding systems. I would like, first of all, to thank all of my interview partners in France, Germany, Great Britain, and

The following number of interviews were conducted: 65 in Germany, 30 in the United States, and 20 in both France and England. Literature on the topic was available in abundance in the United States and almost absent in France. In Germany, publications of the Scientific Council and the German Research Conmiunity provided a fair background. In England one finds, in addition to good documentation on the Medical Research Council and the excellent report of the House of Lords Select Committee (Select Conunittee 1988), several books on medical research written by insiders.

This page intentionally blank

Introduction

the United States for the frank and informative way in which they elucidated for my benefit how health research and its funding systems functions and the problems it faces. I am particularly grateful to all those individuals working in the framework of the German Ministry of Science and Technology's federal program "Research and Development in the Service of Health," (now called "Health Research Programm 2000"). Pierre Corvol in Paris, Richard Krause at the Fogarty Center of the National Institutes of Health in the United States, Diana Garnham and the Medical Research Council staff in the United Kingdom provided me with invaluable assistance in getting acquainted with the peculiarities of their respective countries. They have given their wholehearted support to my research project. At the Max Planck Institute for Research on Society, where I was employed while conducting the research, the stimulating and critical comments of Renate Mayntz, Fritz W. Scharpf, and Uwe Schimank have sharpened the analysis and improved my theoretical insights into the subject matter. For excellent technical assistance, I would like to thank Markus Winnes at the University of Heidelberg. Finally, I am obliged to the Minister for Science and Technology in Germany for generous financial assistance.

Parti DIMENSIONS AND DYNAMICS OF HEALTH RESEARCH

2.

DIMENSIONS OF HEALTH RESEARCH

Health research pursues two major cognitive interests: on the one hand, health research can raise the question of the somatogenic causes of, and therapeutic cures for diseases. This orientation usually corresponds to the cognitive interest of natural-science-based biomedical and clinical research. On the other hand, health research can also raise the question of the social and ecological conditions for staying healthy and preventing disease. This is the field called public health. The following two questions point to the difference in their respective cognitive orientations. Natural-science-based medicine asks: How can I know and recognize as early as possible that someone is suffering from a disease, and what can we then do in order to stop or reverse the process of disease? In contrast, public health research asks: Under what conditions do humans remain healthy or does the incidence of important diseases drop, and what can we do in order to establish or maintain these conditions for as many people as possible?*

2.1

BIOMEDICAL RESEARCH

Biomedical and clinical research can easily be divided into a basic-research phase and an applied phase;^ this, however, is not an adequate

hi an information leaflet of the Harvard School of Public Health, the difference between natural-science-based medicine and public health is formulated in the following way: "In general, as a personal physician aims to maintain the health and to diagnose and treat diseases in an individual, the goal of the public health professional is to understand and meet the health needs of communities, groups and nations. Where medicine follows a personal service ethic, conditioned by an awareness of social responsibilities, public health is governed by an ethic of public service, tempered by concern for the individual." Actually, in terms of cognitive interests, health research can be classified into three phases: research that is basic science oriented, strategically oriented, or applied in character. Whereas basic-science research (or simply, basic research) aims at the acquisition of new knowledge without any specific purpose in mind,

12

Dimensions and Dynamics of Health Research

representation of its many-sided character. Further subdivisions are helpftil for understanding the problems of health research. The goal of basic biomedical research is "primarily to shed light on a biological phenomenon in the area of disease" (Gerok 1979: 10). This includes "all forms of investigation of the causes, formation, and course of diseases as well as [all forms of] scientific activity concerning their explanation and treatment...that emerge from the medical treatment of the sick" (Wissenschaftsrat 1986a: 5). This research is divided into completely different phases of research employing different instruments, and it is often carried out by investigators in different disciplines and research institutions. If the ultimate rationale for clinical research is scientifically based medical action, then the "explanation of cause and pathogenesis of symptoms, diseases, and the course of diseases" is the first cognitive step (ibid.). Contributions to this can be made by basic research in biology and medicine, which takes up cellular and molecular-biological processes in living organisms with the goal of uncovering the basic rules of bodily (dys-)ftmctions. In this area, the object of study is not yet restricted to definite pathological phenomena; instead, the effort is made - albeit with an increasingly strategic orientation towards controlling disease^ - to first discover the mechanisms regulating biological

strategic research is oriented toward application, but in such a general way that this application is not yet precisely definable. In this study, the term - basic (-science-oriented) biomedical research - is subsequently used in a sense combining both basic (-science-oriented) and strategic research. Applied research uses knowledge developed in basic or strategic research and tries to think about ways how to make them applicable within different user subsystems. Thus, an investigation of the genesis and development of tumor cells can serve the general purpose of providing some information about the regulating mechanisms of the controlled and uncontrolled growth of cells in living organisms. At the same time, it also provides the possibility of laying the foundations for specifically influencing the uncontrolled growth of tumor cells and in this way contributes to the fight against cancer. It is characteristic of the current interlinkage in basic research between biology and medicine that it is becoming increasingly easy to make the move from the "findings of pure research" (e.g., knowledge about cell growth) to a strategic orientation toward disease (fighting cancer). There is a convergence of interests between biologists and biomedical researchers.

Dimensions of Health Research

13

phenomena and their impairment. Research activity is usually carried out in the laboratory, and the objects of research are either in-vitro cultures or vivisection. Disciplines here include cell biology, molecular biology, immunology, virology, parasitology, biochemistry, biophysics, genetics, and microbiology, as well as botany and zoology. It is indisputabletfiatsince the discovery of restriction endonuclease and sequential analysis made DNA recombination technology possible in the mid-1970s, research applying the methods of molecular biology and molecular genetics has led to an immense increase in knowledge about the foundations of bodily reactions and possesses great potential in the recognition of the causes of chronic and more recent infectious diseases. At the same time, it provides new avenues of therapy and diagnosis. If this kind of research is viewed as a preliminary phase to clinical application, then in the first actual phase of clinical research, focus is specifically directed to the investigation of diseases. In this context, the preclinical disciplines of human-medical theory (anatomy, physiology, pathophysiology, pharmacology, toxicology, human genetics, medical biometrics) and the basic-science disciplines of biology and medical make similar research claims. This has not always been the case. The disciplines of human-medical theory generally employ different methods than those furnished by molecular biology. This division is rapidly being transformed: There arc some good reasons for considering the distinction between the basic, scientific disciplines in biology and medicine, on the one hand, and theoretical human-medical research, on the other, as obsolete, since in the light of modem methods the boundaries between the two fields are becoming ever more blurred. (DFG 1987: 121)

The more descriptive and morphological approaches of the theoretical disciplines of human medicine apparently need increasingly more supplementation through the methods and problems posed by biochemistry and cell biology (DFG 1987: 153). It still makes sense to distinguish basic biological and medical research from the theoretical disciplines of human medicine, because the process of the increasing interlinkage of their methods and results has hardly reached its conclusion yet. Moreover, the institutions that perform these kinds of research are still frequently distinct from one another. Even in the first clinical phase, work is largely done with in-vitro and animal experiments. In the second phase, th^ patient and the institution of the hospital are incorporated into the research process. Here the effort is to

14

Dimensions and Dynamics of Health Research

apply the conceptual models developed in the previous phase to humans in order to provide the physician with new "tools" for diagnosis and therapy. More than ever before, working out application-related therapeutic concepts and diagnostic procedures has become the point where the basic biological and medical disciplines, theoretical human-medical disciplines, and clinical disciplines^ intersect. If the aim is to incorporate the insights of basic research into clinical practice, then investigators trained in the natural sciences and physicians have to work together at this point. In clinical research on patients, the second and third phases of investigation take place: First of all, the conceptual models developed in the laboratory are tested "on voluntary patients or healthy test persons in order to gain new knowledge and experience" (DFG 1987: 169). Only when this is successful and one is convinced of the possible application of the models to humans is a further phase required: a statistical corroboration of these causal relations by means of randomized, often multicentric, therapeutic studies (the third phase). The research carried out in this third phase is more oriented toward large groups and requires not only the clinical research work of physicians but also epidemiological and biostatistical corroboration.^ In Table 1, the different investigatory steps in clinical research are once again presented, broken down according to strategic orientation, research setting, research object, and cognitive interest.

The clinical disciplines include those involving conservative treatment (e.g., internal medicine, pediatrics, dermatology, neurology, radiology, dentistry, occupational medicine), those involving operative treatment (such as surgery, orthopedics, urology, ophthalmology, gynecology), and psychiatry and psychosomatic medicine (DFG 1987: 171-182). For Gerok (1979) and the Scientific Council in Germany, the second and third phases of clinical research represent totally different basic types of research that proceed differently "in terms of cognitive goal and methods employed" (Wissenschaftsrat 1986a: 5). In the first type (which includes what has been termed above the preliminary phase, the first and second phases), the "methods of the basic medical sciences" are employed. In the other type (research in the third phase), research is "directly oriented toward the scientific grounds of the medical practice," where "for example, the effects of different forms of therapy or risk factors are investigated with the aid of statistical methods applied to large collectives" (ibid.:5-6).

15

Dimensions of Health Research

Table 1:

The research process in natural-science-oriented, clinical research Strategic Orientation

Site

Subject

Method/Goal

Biological phenomena

Laboratory

Cells, molecules

Discovery of biological interrelationships

| | |

Disease

Laboratory

Animal, in vitro

Discovery of pathogenic mechanisms and causes of disease

| | | |

Disease

Hospital

Individual patients

Application of discovered correlations to humans

| | | |

Disease

Several hospitals

Patient population

Testing of correlations by means of randomized, multicentric, clinical studies

|| | | | | |

Basic II research

1 Strategic 1 research

1 Applied 1 research

2.2.

PUBLIC HEALTH RESEARCH

Within public health research, one can distinguish population-oriented and systems-oriented health research.^

between

9 hi a report of the House of Lords Select Committee (Select Committee 1988: 7), the distinction is made between "public health research" and "operational research." "Operational research" is "...the term used for applied research concerned particularly with the effectiveness of service provision and administration..," whereas "public health research...cover[s] all strategic and

16

Dimensions and Dynamics of Health Research

The former encompasses the conditions of sustaining health, i.e., the prevention of diseases insofar as they are conditioned by environment and behavior, but also aspects of general hygiene, such as the promotion of psychic and physical well-being. Since, on the one hand, individual life-styles,^^ which are themselves based on social and political conditions, are responsible for the health of a given population, and, on the other hand, environmental factors also play a decisive role, it becomes plausible for the social and behavioral sciences to play an important part in any public health research. From the very outset of the health sciences at the end of last century, the performance, efficiency, and adequacy and fairness with which the structures and services of the health system meet needs have represented a basic interest of public-health research. For these sciences arose in connection with political problems, such as controlling epidemics and promoting health. Political decision-makers, therefore, expect future public health research make contributions that improve the preconditions for an effective public health system. Above all, this involves the improvement of systems of medical care. Subjects such as health economics, the technical administration of public health, planning and administration in the health system, health policy, quality control, evaluation research, research of health systems, rehabilitation research, and health care research belong to the areas of potential research within the realm of the health system. Epidemiology, biostatistics, occupational medicine, sociology of medicine, behavioral medicine, and health and the environment, on the other hand, probably should have a central place in population-oriented health research. Five tasks can be distinguished that investigators in public health research either still have to tackle or that are already being handled in order to meet the increased demands both on rehabilitation and the health care system (i.e., the cost explosion in most health systems today) and on the research of the effects of life-styles and environmental contaminants on health.

applied research concerned with the health needs of the community as a whole, including the provision of services to meet those health needs." 10 Life-styles are defined as patterns of individual behavior that are prevalent in certain societies and social groups.

Dimensions of Health Research

17

• Population-related, epidemiological studies, the continuous collection of health-related data, and the systematic evaluation of these data according to binding standards form the basis for increasing the efficiency of health system services and for providing better accountability for political action. Moreover, the epidemiological determination of risk factors and the public dissemination of this information can improve diagnosis and therapy. Such tasks have to be assumed by epidemiologists (as yet scarce in the Federal Republic and in France), biostatisticians, health economists, general practitioners, clinical specialists, statutory health insurance agencies, and the corresponding bureaus of statistics. • To gain knowledge about social and environmentally related opportunities of prevention, two different research tasks are entailed: on the one hand, the connection between individual risk factors and disease has to be more precisely defined. On the other hand, extended studies of intervention have to be made in order to ascertain by which means the acceptance of preventive measures by the general public can be improved. Preventive research requires the cooperation of a large number of institutions, for example centers for health information, statutory health insurance agencies, municipal bodies (since intervention usually takes place on the local level), hospitals (helpful in the evaluation of samples and data), other agencies active in the health care subsystem, and other public-service institutions. • Research on the interaction between environment and health is primarily concentrated on the relationship between harmful substances and the causes and course of disease. In this context, toxicology and epidemiology represent the most important directions in research. In the long term, toxicological data banks have to be established, evaluative methods developed, and the results successfully integrated into municipal prevention efforts and physicians' practice. This presupposes close cooperation between natural scientists, epidemiologists, health-related municipal services, and physicians. • Health-system research, evaluation research, and health economics focus on the needs adequacy and cost efficiency of the administration and services of the health care subsystem. In these research areas, different legislative measures concerning the health care subsystem, the services

18

Dimensions and Dynamics ofHeahh Research

of insurance carriers and health insurance agencies, and other health-related, public-service institutions are assessed in terms of their performance and efficiency. • Patient care and the development of lay potential are central elements in patient-care research, rehabilitation research, and in studies in medical sociology. In these research fields, the aim is to establish how the disease-impaired can better cope with their condition, how self-help among the general public can aid the professional system of health care, and more generally, how this system can more adequately and efficiently meet needs. Especially in rehabilitation research, (psycho)social studies represent an important component, forming a bridge between the short-term intervention of the physician and the long-term care of the patient.

DYNAMICS OF HEALTH RESEARCH

The prevalence of different diseases, the population and age groups affected, and the frequency distributions of morbidity and mortality are in a process of constant change. Due to this, health research, medical practice, and health policy are constantly faced with new tasks. The optimal management of these tasks is contingent upon institutionalized knowledge and flexibility of action. In recent years, a specific dynamic has arisen in several areas of health research and in the treatment and care of the ill, which in its character and pace of development represents a great challenge to the processing capacities of the institutions and actors involved in health research. Five factors characterize this dynamic: • Social progress (prosperity, better working conditions, hygiene) and the achievements of medicine^^ have increased the quality and length of life of the general population. This has greatly increased the percentage of the elderly in the overall population. Because this elderly age group more frequently suffers from cancer, rheumatism, and cardiovascular disease, it has been necessary to pay more attention to chronic diseases. The latter, however, in contrast to infectious diseases, have multifactorial causes. They can arise through the interaction of genetic data, viral infections with long latency periods, life-style, and environment. The more complex diagnosis and therapy required here is made even more difficult by the fact that the elderly often suffer from several diseases at once (multimorbidity). The two syndromes (chronic disease and multimorbidity) demand from the physician highly complex and integrated concepts of diagnostics and therapy. When chronic diseases are the composite result of the interaction of such varied factors, medical practice has to be informed by the findings and possibly also the methods of basic research in biology and medicine as well as those of psychological or public-health research.

11 Medical technology in particular has been successful in many areas (e.g., by means of dialysis or cardiac pacemakers) in prolonging the life of the ill. This equally holds for recent developments in drug therapy (such as [human] insulin and new antibiotica). Methods of early diagnosis, moreover, have made possible the timely diagnosis of diseases and thus higher rates of survival and cure.

20

Dimensions and Dynamics of Health Research

In general, a "holistic" approach is expected in the treatment of disease. Such an approach is totally in keeping with the experiential horizon of the general practitioner. Complex and integrated concepts are likely to represent a problem for clinicians, however, who usually confront patients in (university) hospitals at a high level of specialization. They have been trained as specialists in order to make short-term interventions on in-patients. However, such interventions are often no longer sufficient, failing as they do in the ever more urgent and frequent tasks of integrating into the physician's own practice and therapy post-illness rehabilitation and the process of teaching the patient to "learn to live" with disease. Adequate long-term intervention cannot be introduced overnight, though. The tasks of clinicians would have to be redefined and their training restructured. It would also be necessary to create organizational structures that facilitate the interlinking of in-patient and out-patient treatment. Such new structures should also promote the interdisciplinary cooperation of scientists involved in rehabilitation (such as rehabilitation psychologists), paramedical professionals, nonclinical institutions, and clinicians. • The increasing relative size of the elderly age group has consequences for more than just clinical activities of treatment and research: it also affects the health care subsystem as such. The costs of health care rise due to the need of increasingly more individuals for longer periods of therapy. Accordingly, organizational structures and services have also to be provided in the fields of clinical treatment and patient care. Similarly, the need for more intensive treatment and more elaborate technology continues to increase. The growing demands on the health care subsystem create the need for flexible and efficient organizational structures in the face of the increasing scarcity of public funding. Since, however, our knowledge about the way that the health care subsystem ftinctions is still rudimentary, research has a lot of catching up to do. • Immanent developments in science can hardly be planned and are, for this reason, also not foreseeable. But they form one of the central impulses behind health research and, in this way, behind physicians' practice. As touched upon above, the discoveries in cell biology, molecular biology, and molecular genetics are likely to lead to a major transformation of knowledge about the causes, therapy, and diagnosis of disease. The more

Dynamics of Health Research

21

molecular biology develops into the fundamental method of overall biomedical research - and its diffusion into other disciplines appears unstoppable - the greater the pressure on clinicians will become to integrate within their own experiential horizon (based as it is on application-oriented and morphological-descriptive methods), the methods of molecular biology and a context of reasoning founded upon the natural sciences.^^ With the growing predominance of molecular biological methods, there is also a tendency, however, to create new clinical disciplines committed to the scientific reasoning of molecular biology (such as clinical virology or clinical immunology). This entails a redefinition of the medical licensing process and the structure of medical education. New and unforeseen problems can provide additional impulses for research. Thus, completely new modes of cooperation among investigators, physicians, and politicians were prompted by the acquired immunodeficiency syndrome (AIDS). The combined approach of (international) etiological research by means of studies in molecular biology and epidemiology, on the one hand, and the therapy and diagnosis of AIDS in clinical research and practice and its prophylaxis by means of well-directed health information campaigns among the general public, on the other, has contributed to a "holistic" approach to the disease. Presumably, this will also have effects on the way in which other diseases are investigated and treated. The interconnection of completely distinct fields of research and activity has once again called to mind that the control of disease can only be successful if elements of prevention, etiological research, and clinical practice are combined with each other.

12 Gerok (1989: 42) puts it as follows: "It is unmistakable that clinical research has to integrate to an ever-increasing extent the methods of basic research in medicine, such as biochemistry, biophysics, immunology, cell biology, or molecular biology, if it aims to be original, penetrating new territory, instead of just being complementary [in function]. Thus, the methods of cell biology and biochemistry were needed to demonstrate that hepatic cells—even of the same shape and genetic information—take on different functions according to their position within the substructures of the liver..."

22

Dimensions and Dynamics of Health Research

• The fact that research can also react to societal and political pressure is currently being demonstrated by the relevance of environmental and AIDS research. • In conclusion, one other component of health research should also be pointed to, the dynamism of which is frequently underestimated. For not only diseases are rapidly disseminated across the globe; the same holds true for our knowledge of health and illness. In the last ten to fifteen years, there has been an increase in international contact among researchers and policymakers in the health field. This has made possible not only the more rapid diffusion of knowledge and methods, but also the increasing discussion of national deficits in health research, prompted by international comparison. It has been shown, for example, that the national representatives participating in the health researchftindingof the European Community hold very similar views on the kind of problems andftindingstrategies in health research (Behaghel and Braun 1993). This international awareness provides actors with a more differentiated and precise understanding of the weaknesses of their own systems. At the same time, greater attention is given to the advantages offered by other countries, and there is an increased desire to have them introduced into one's own country. For example, the research structure in the Federal Republic has frequently become the object of discussion - something that was already true for university structures in the 1960s - as a result of the increasing attention given to the well-developed interdisciplinary structures in the United States. One can conclude that the driving forces active today present three challenges to the structures of health research and the health care subsystem in most countries: (1) The discoveries that have become possible through the development of recombinant DNA technologies in the mid-1970s, which follow one upon the other in ever-shorter increments of time, promote an increasing specialization of knowledge and the formation of new specialties in medicine. The multifactorial causes of disease, the increase in multimorbidity, and a new critical awareness of the interconnection of life-styles, environment, and disease require at the same time the combination and integration into clinical

Dynamics of Health Research

23

practice of the knowledge and findings yielded by the different directions of research. Thus, the disciplinary structures and actors in medical departments are subject to both centrifugal and centripetal tendencies: specialization requires a division of labor in research, the differentiation of distinct disciplines, and a decentralization of resources. Integration, on the other hand, necessitates cooperation and communication between disciplines and investigators as well as a concentration of resources. The medical disciplines have to reorient themselves today within this field of conflict, since the ability to control disease has been transformed by the discoveries and methods of molecular biology. (2) In public health one still finds a lack of valuable scientific knowledge which could guide the practices of policymakers and physicians for the better. (3) Demographic shifts, chronic diseases, technological developments, but also increasingly expensive biomedical research have resulted in a great increase in the costs of health research and health care. Given scarce financial means, this presents a challenge to allocation structures and to the performance of the health economy. The following conclusion can be drawn from this: if the health of the greatest possible number of citizens and thefinancialviability and quality standards of health-care structures are the primary aims of health research, then the first crucial point is the extent to which clinicians can be induced to reactflexiblyto the new demands. Moreover, they also have to be capable of integrating population-based and social scientific findings as well as molecular-biological hypotheses into their own research and, ultimately, into clinical practice. The second crucial point is the degree to which a country succeeds in establishing scientifically grounded activity in the area of public health research, while at the same time paying attention to the needs adequacy and cost-efficiency of medical care. This study will take up thefirsttwo problems and leave aside the problem of cost efficiency, which is primarily a question for health economics and health care subsystems research. If the argumentation put forth up until this point is accepted, then clinical research in many areas is faced with the task of incorporating new cognitive

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Dimensions and Dynamics of Health Research

fields closely related to biological and preclinical knowledge. Public health research, on the other hand, has to meet the challenge of successfully completing the paradigmatic stage of scientific development. The next three parts of the book will extensively discuss the problems actors encounter in trying to take up these challenges in health research. Part 2 is dedicated to the problems besetting clinical research and to the strategies implemented in funding systems to solve these problems. Basic questions here are: What are the problems besetting clinical research in organizing the transfer of basic biomedical knowledge into clinical research and application? Are there any differences between the United States, England, Germany and France in their strategies and solutions to problems in clinical research? How can we account for these differences? Part 3 asks: what can funding agencies do to alleviate the problems in clinical research? Will we find variations in the problem-solving capabilities of funding agencies in the four countries, and how can they be explained? Part 4, finally, addresses the question as to why we should find obstacles to the establishment of scientifically grounded reasoning in public health research and how countries differ in the support they provide to this area of health research.

PART 2 CLINICAL RESEARCH: PROBLEMS AND INSTITUTIONAL CONDITIONS

4.

BASIC PROBLEMS BESETTING CLINICAL RESEARCH

Clinical research is a field located at the point where science and medical practice intersect (King 1982). It always takes place in the organizational context of university medical departments or medical schools^^ and in hospitals associated with such institutions.^"^ The leading actors in clinical research are the clinical doctors at university medical schools.^^ In all countries, the tasks assigned clinical professors are not confined to research and teaching. Since their activities are always linked to professional training and performance, contact with patients and patient care also represents an important aspect of their activity. Consequently, clinical professors are the actors with the greatest degree of role differentiation in universities. In most university systems they are expected to allocate their resources of time equally among the three functions. This is usually not the case, however. My research in the four countries studied demonstrates that the growing impossibility of any one person adequately performing all three of these functions is at the basis for both the mediocre scientific results achieved in clinical research and for difficulties experienced in transferring basic knowledge into clinical application. The image of the excellent scientist and superior physician united in the person of the clinical doctor is no longer realistic (see also Sachverstandigenrat 1991: 178). What is taking place instead is the progressive differentiation of the respective roles of practically oriented clinicians and research-oriented clinicians. Accordingly, what we often do find today is a clinician who concentrates his or her time resources and activities on only one or two of the following types of activities: • Many clinicians-this is especially true for France and Germany-identify themselves with patient care and develop a self-image of their role that

13 In the following, reference will usually be made to "medical schools" even when France and Germany are concerned, where there are actually only "faculties of medicine." 14 The only exception is the Clinical Center of the National Institutes of Health (NIH) in the United States. 15 They are simply called clinicians or clinical doctors in the following. In contrast, I use the term physician to refer to medical practitioners who are not members of medical school staffs.

28

Clinical Research: Problems and Institutional Conditions

corresponds to that of a physician. For them, (clinical) research is of little importance. • Other clinicians do perform clinical research, but proceed largely in terms of their own practical experiences. They provide clinical research with input information, but have little to do with bench research, i.e., with utilizing this data in terms of the most recent results of basic research (see also Vaitukaitis 1991: 155). The clinical research of these clinicians is largely focused on specific problems and exhibits a practical orientation. • Finally, a third group of clinicians identifies with the process of scientifically evaluating cognitive advances as such and focuses on basicscience- and theory-oriented (clinical) research, seeking ultimately to effect change in medical practice on the basis of their findings.^^ They are often intimately linked with the scientific community of biomedical researchers. This group is clearly in the minority in Europe. Its great significance, however, rests on its very ability to translate new findings in molecular biology into the procedures of clinical research. The increasing demands on the role of the clinician are not only adverse to the combination of the roles of researcher and physician in one person. In addition, they make it difficult to establish lasting cooperation between physicians or practically oriented clinicians, clinicians interested in research, and biomedical investigators from the biological or preclinical departments. For these reasons, it seems almost impossible to actually pursue two potential courses for improving the transfer of basic biomedical knowledge into clinical application, that is, either by increasing the capability of clinical doctors to deal sequentially with patient care and research or by facilitating understanding between the array of actors just cited. There are a series of factors connected to the social organization of biomedical science and medicine which explain the difficulties involved in adopting either strategy.

16 They thus engage in "scientific medicine." "Scientific medicine...would be the practice of medicine insofar as its practitioners rely on the technology, the methods, and the theories of science, especially the biological sciences" (King 1982: 196).

Basic Problems Besetting Clinical Research

4.1

29

DIFFERENTIATION TENDENCIES EMERGING FROM THE SOCIAL ORGANIZATION OF SCIENCE AND MEDICINE

The roles that social actors assume are, in the first instance, not determined by the institutions in which these roles are played, but by the social subsystem that the actors assign themselves to/^ A social subsystem is based on the common orientation of its actors toward recognized rules of interaction and communication, generally accepted social expectations, norms, and collective sanctions. Even though all clinicians are members of the university qua institution, they can certainly differ from one another according to the social system they consider themselves members of. Clinicians seeking to engage in theoretically oriented research tend to consider themselves part of the social subsystem of science, whereas medical practitioners recognize the rules and norms of the health care subsystem. Social subsystems have a tendency toward closure, i.e., they create "boundary controls" and negative sanctions for social actors who attempt to leave the social context in which they have worked up until then (see Braun 1993b). This both inhibits clinical doctors from assuming the dual role of scientist and physician and impedes cooperation between groups of actors stemming from different cognitivefields.Differences in cognitive perception

17 The use of the concept subsystem makes reference to the existence of boundaries and self-referential processes. The term self-referential, in turn, refers to Niklas Luhmann's theory of autopoietic systems (see esp. Luhmann 1984). Without wanting to go into too much theoretical detail, in Luhmann's own words, autopoietic or self-referential subsystems can be defined "by their ability to reproduce the elements they consist of by using these same elements" (Luhmann 1987: 113). Such systems develop their own unique mechanisms and procedures. "Hence autopoietic systems are closed systems dependent on themselves for continuing their own operations" (ibid.). This concept is used here to illustrate that the dual location of biomedical research in two different subsystems (i.e., in the respective subsystems of science and health care; I will ignore its foundations within the educational system for reasons of simplicity) can result in specific transfer problems that arise from impediments to conununication and differences in interests between the two subsystems.

30

Clinical Research: Problems and Institutional Conditions

and in credibility cycles and the increasing complexity of the activities in question account for this closure. 4.1.1 Divergent Cognitive Perceptions as a Dissociating Element The tendency to remain within a given social subsystem once it has been chosen is brought about by the cognitive faculties and attitudes of actors shaped within and by that social subsystem. What it does not explain, however, is why it is difficult to incorporate the scientific findings of biomedical research into the practical knowledge of clinicians. The cognitive interests of clinical doctors and natural-scientific, biomedical researchers are distinguished in terms of their primary points of reference. The special responsibility of clinicians to their patients and the duties connected to this compel them to make primary recourse to knowledge which makes possible secure and risk-minimizing action. Since physicians cannot allow themselves to make any mistake that might jeopardize their patients, they are much more dependent on empirically secured findings than are experimental, biomedical researchers, who work with animal and in-vitro experiments.^^ Studies in cognitive psychology have convincingly demonstrated that medical and scientific activities necessitate different styles of thought (medical practitioners requiring a more classificatory-inductive

18 The DFG had already touched on this aspect (as well as many others) in 1968 (DFG 1968: 32): "The clinical specialist must not only be capable of, but also has to be put in the position to be able to create that atmosphere of hope and trust in which alone the desire to recuperate flourishes. No collective effort can provide this...New diagnostic and therapeutic procedures do not only extend the range of medical action; they also create problems that test to a previously unknown extent the conscience and feeling of responsibility of the doctor in attendanc. He must provide the indication for diagnostic interventions, some of which are beset by not inconsiderable risk rates. He has to command an extensive therapeutic repertoire, which, if not fuUy exploited, can mean the death of some of the most seriously ill [..] These and other problems repeatedly put him in a position where medically desirable activity can be transformed into inhumane activity that is falsely considered productive. He thus acts within an *area of tension' which frequently demands too much of the person who attempts, aside from clinical work, to carry out the additional tasks of research and teaching."

Basic Problems Besetting Clinical Research

31

way of thought, whereas researchers require a more axiomatic-deductive style; see Evans et al. 1989). These studies have also shown that the combination of these two styles of thought rarely occurs. It follows from this that the acquisition of scientific knowledge can never become the sole purpose of clinicians - unless and until they completely submit to the reputation mechanisms of science. Research, in the eyes of clinicians, is always a means of enhancing the performance of the function of practicing physician.^^ The divergent reference points of action, decisive for the clinician and the natural-science-oriented, biomedical researcher, lead to totally different attitudes toward the research process. Decisive for clinicians is a practical orientation in research and experiential knowledge in practice. They are drawn to useful, descriptive research activity. Biomedical investigators oriented toward natural science (and molecular biology) usually have, without doubt, a strategic orientation. Nevertheless, the reference point of their action is the explanation of biological phenomena, the acquisition of scientific knowledge, and thus an orientation toward basic research. Application is a secondary priority. Risky and innovative research activities are necessary here in order to make new discoveries. The two different orientations of action involved here can be summed up under the rubrics of the "truth orientation"^ of the (natural) scientist versus the "curative orientation" of the clinician. The features outlined above have been borne out by the studies of the four countries investigated. Understanding between scientists and practitioners presents difficulties in all of these societies. The developments of molecular biology have tended to increase this difference in the respective perceptual frameworks of physicians and scientists. Whereas the preclinical-theoretical disciplines and the clinical-

19 "The difference between clinical rationality and scientific rationality is that clinical rationality is not a tool for the exploration or discovery of general principles, as is the scientific method, but only a tool for sorting the interconnections of perceived and hypothesized facts. * Principles' are generated in the course of clinical practice, but they are generalizations from clinical experience, which is to say, generalizations from personal and systematically biased experience." (Freidson 1970: 171-172). 20 According to Luhmann (1970), truth (i.e. the acquisition of new knowledge) is the primary point of reference differentiating the scientific system from other subsystems.

32

Clinical Research: Problems and Institutional Conditions

practical disciplines were previously largely able to refer to a shared paradigmatic and experiential framework in their efforts to communicate with one another, the incorporation of techniques of molecular biology into preclinical disciplines has increasingly widened the gap between these two realms. The new style of thought in basic biomedical research requires a willingness on Uie part of actors in the social subsystem of health care to accept a change in their way of thinking. It is understandable that such a process of adjustment runs into resistance in the clinical disciplines on both an intellectual and an emotional level. This resistance is further intensified through other dissociating mechanisms. It can be seen in European countries that both medical practitioners and scientists consider their own status or activity of higher value than the status or activity of their counterparts in the other social subsystem.

4.1.2 Credibility Cycles as a Dissociating Element What ultimately ties actors to a social subsystem is their involvement in a cyclical pattern of personal investments (in the form of money, time, energy, and knowledge), social reward in the form of recognition and/or money, and enhanced reputation (the reward or credibility cycle; see Latour and Woolgar 1979; Kohler 1989; Rip 1988; Braun 1993b). It is reasonable, as Mayntz has pointed out (Mayntz 1988: 31), to complement the functional reference point of action I have introduced above (i.e., the search for truth or the curing of the patient) with another dimension that relates to the individual motivation of the actor. For Latour and Woolgar the scientist (and one might add, the actor in general; see Braun 1993d) is motivated to act by the desire to keep producing under the best possible conditions (see also Kohler 1989). The actor is only in the position to continue his or her activity, however, if he or she contributes to the functional requirements of a given subsystem or of a specific social-structural environment. The scientific researcher at the university, for example, can only make a claim on resources if he or she has successfully taken part in the process of accumulating knowledge. In contrast, a researcher in private

Basic Problems Besetting Clinical Research

industry is not rewarded for the scientific merits or creativity of his or her findings, but for developing cost-efficient and marketable products. The physician or practically-oriented clinician needs to demonstrate his ability to cure patients. The credibility cycle however, puts narrow limits on action, exerting pressure on the members of social subsystems to act in accordance with a precisely established course of procedures. An actor's credibility cycle is placed in jeopardy by the frequent and especially persistent overstepping of the bounds of the social subsystem that this actor considers him- or herself a member of, i.e., by taking part in the production of services for other social subsystems (see also Braun and Schimank 1992). The returns on investments made can be accumulated and, in the course of time, represent a kind of "social capital" (see Bourdieu 1975; Coleman 1990) within the social subsystem involved. It is not possible, though, simply to transfer this social capital to other social subsystems .^^ Moreover, it begins to lose its value if it is not reinvested. Crossing boundary lines, either in the form of interdisciplinary cooperation between medical practitioners and scientists or by unifying both roles in one person are thus risky, since such actions might permit previous achievements to fade or not grant the actor enough time to compete for the scarce commodity of reputation. For this reason, social actors tend to refrain from overstepping such boundaries.

4.1.3 Institutional Incentives as a Dissociating Mechanism While credibility cycles, therefore, limit an actor's capability to participate in time-consuming interdisciplinary activities and inhibit cooperation and communication between scientists, clinicians, and physicians, this is not the only reason why clinicians are one-sidedly drawn into the occupation of curing patients instead of exploring the "truth." There are in fact a number of incentives that induce clinicians to focus on their roles as practicing physicians:

21 For example, social capital acquired in science can help in obtaining a political position. However, further advance in politics then requires new investments and the acquisition of different social capital.

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34

Clinical Research: Problems and Institutional Conditions

Like no other profession, the medical profession enjoys an especially good reputation in society, often much more highly esteemed than that of the scientist.^^ This reputation is based, on the one hand, on the great importance that the general public accords to health. On the other hand, as Stone shows, it is founded on the lay conception that diseases are caused by disease-causing agents and require the intervention of the physician in order to be cured. "Thus physicians become the 'heroes' capable of fighting the invaders" (Stone 1980: 8). The high societal regard for physicians favors high income (especially upon reaching the position of clinical professor), far superior to that of a biomedical scientist. Finally, the career mechanisms of the clinician are also tailored to patient care. In many countries, the greatest rewards are reserved for specialists who prove to be especially successful in treating patients and, accordingly, have established reputations of being able to "attract" a great number of patients, contributing in this way to the optimal utilization of the hospital. A further reason for the patient-orientation of clinicians is found in the academic training of physicians: after the preliminary medical examination, medical-school education is dominated by the clinical disciplines and practical training at the sick-bed, rather than the promotion of scientific activity. Patient-oriented education and the positive externalities of patient care can motivate clinicians to adopt the career path of the physician rather than that of the scientist. This may explain the low numbers of scientifically interested clinical researchers, especially in the European countries.

4.1.4 Increasing Complexity as a Dissociating Element Functional activities in a complex world necessitate ever-greater efforts just in order to assimilate the sheer of bulk of requisite data. The development of new methods and technologies and cognitive advance in science and

22 There are, of course, national differences. For a long time, the scientific profession was the most highly valued in the United States, and this held to a lesser degree for Germany as well. In contrast, in Great Britain and France, it clearly enjoyed less of a reputation than the medical profession.

Basic Problems Besetting Clinical Research

35

medicine demand increasingly more time from actors seeking to compete successfully for reputation. This time argument was cited by many of the experts interviewed. They consider it increasingly impossible for a single individual to perform equally well in both science and medicine, given the ever-growing cognitive demands and the scarcity of time resources. The complexity argument points to the necessity of thinking in the future in terms of the institutionally organized collaboration between scientifically oriented actors and medical practitioners. This approach, however, will be forced to counteract the dissociative tendencies between the scientific and health care subsystems that arise on account of differences in cognitive perception and credibility cycles. Though there are, thus, quite a number of trends which compel actors to dissociate rather than cooperate and to choose only one role instead of combining several, various national experiences demonstrate that such structural dynamics need not result in a complete failure of health research systems and their accompanying funding systems to meet to the challenges in health research. It is generally known that the United States has fared well in basic biomedical research and has managed to be reasonably productive in both clinical and public health research. The scientific productivity of European countries in health research, on the other hand, is rather disappointing. Though there are no hard figures on the differences in performance between the United States and European countries, there are sufficient indications corroborating this point. Stossel and Stossel (1989) have attempted to compare the number of articles of U.S. origin with all others published in the leading journals of clinical research and have shown that in the period from 1978 until 1988 American clinical scientists accounted for about 80% of all articles appearing in the "Journal of Clinical Investigation" and the "New England Journal of Medicine." A second indicator is provided by the interviews I conducted in the four countries: there was hardly any scientist, clinician, or sponsor who did not concede the predominance of the United States in health research. Finally, it can be shown that most health research grants applied for in Great Britain, France and Germany requested an education or research sabbatical in the United States. Though I am quite aware that these indicators are very "soft," I still contend that they point to a clear division in performance in health research between the United States on the one hand and European countries on the other.

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Clinical Research: Problems and Institutional Conditions

In my view, institutional structures and the role of funding agencies are the two decisive factors which account for the variation in the health performance of the four countries investigated. We will, therefore, now turn to a description of differences in institutional organization at the level of clinical research before turning to the policies of funding agencies. The question thus is: which institutional framework of research conditions is advantageous for cooperation between basic researchers, clinical researchers, and physicians, and which one is disadvantageous?

4,2

A N INTERNATIONAL COMPARISON OF THE INSTITUTIONAL CONDITIONS OF CLINICAL RESEARCH

The institutional conditions under which research takes place can have a decisive effect on its productivity and innovative force (Ben-David 1971: 169-185). Clinical research is embedded in the organizational context of hospitals and universities. The structures found there form the primary framework of conditions that determine whether research will be successfully institutionalized or not. 4.2.1 Explaining Variations in the Role of Clinical Research (I): Differences in the Models of Association Linking Hospitals and Medical Schools The countries studied here exhibit various ways of organizing clinical research within the organizational coexistence of the medical school and hospital. In France and Germany an integrated model predominates, whereas in the United States and England a differentiated model is followed. A differentiated model designates a structure of affiliation between medical school and hospital that is marked by the separate organization and administration of patient care, on the one hand, and of research and teaching on the other. The hospital and the medical school are each autonomous corporate actors, which periodically enter into negotiations about the character of their association. This contrasts with the integrated model, in

Basic Problems Besetting Clinical Research

which the hospital and the medical school are part of one organizational entity and there is an established legal basis to the form of association.^ The different ways in which the association or affiliation model is designed affects the relative position of the social subsystem of science in the medical schools and hospitals, and concomitantly, affects clinical research. The hypothesis that is developed here reads as follows: the closer the affiliation between medical school and hospital, the greater the predominance of patient care at the expense of the functions of research and teaching. In this case, the social subsystem of health care proves more binding on clinicians than the scientific and educational systems. This impedes the establishment of clinical research. Time certainly represents the most problematic and contested resource in the functional nexus of medical schools and affiliated hospitals. One reason for this is the tendency of every social subsystem to make expanding use of time resources for the performance of its own ftinction.^ Since time resources are allocated among various functions in multifunctional

23 The arrangements existing in France between the centres hospitallers universitairs (i.e., the large hospitals where the medical staff of medical schools is employed) and the medical schools are considered an example of the integrated model, even though these two institutions do not belong to the same organizational entity. However, the relationships between the two organizations are structured in such a long-term way and the interlinkage of personnel is so great that it is not possible to speak of a differentiated model. 24 In the scientific subsystem, this tendency arises through the demand for an increase in knowledge, which then forces further specialization and differentiation. University teaching requires an increasingly greater expenditure of time as the requirements of translating specialized knowledge into the generalized language of teaching increases. (And this does not even take into account such open admission systems as in France and Germany, where the increasing number of students raises teaching obligations, or countries where funding cuts decrease personnel and thus increase the teaching obligations of individual professors, such as in England.) Patient care is time-consuming per se, because it is incompatible with time limitations. The patient has to be cared for night and day.

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Clinical Research: Problems and Institutional Conditions

organizations ,^ a continuous struggle arises for greater shares of existing time resources. The ability of patient care to prevail in the framework of the integrated model rests primarily on the differing time frames that the functions of patient care, research, and teaching are subject to: only patient care can legitimately make an unlimited claim on the time budget of the clinician, since the patient's right to immediate help cannot be reftised, and the care of patients is an activity which does not permit temporal limitations. Though there is also no end to research -the treatment of scientific problems always generates new ones (see more extensively Braun 1993a, Vol. 2) only rarely does scientific research involve the solution of such urgent problems (as in the case of AIDS) that it is able to make a legitimate claim to preferential treatment in the allocation of time resources. In decisions concerning allocation in such multifunctional organizations as universities, medical schools and hospitals, however, it goes without saying that (as long as no areas are specifically set aside for allocation under formal-legal protection and given scarce time resources) those tasks are given priority which are considered more urgent. The complaints of young physicians and many professors about the lack of time resources is most clearly heard in Germany and France (on Germany, see the report of the Sachverstandigenrat 1991: 326). And they are the two countries in which the integration of hospital and medical school is the most advanced. One is initially surprised to find a correlation between the integrated model and decreasing time resources for research, because research has an advantage in France and Germany as compared to the United States: because hospitals are part of the university (Germany) or considered to be so (France), they are subject to political pressure to provide teaching and research with an adequate place within their organizational framework. The university hospitals in Germany are an integral part of the university and thus officially bound by the tasks of the medical schools. The centres hospitaliers universitairs (CHU) in France, in which professors run the

25 I use this term to describe organizations that have the task of satisfying functions specific to several subsystems (see Braun and Schimank 1992). Examples of this are universities and university hospitals, but also government-department research facilities and industrial research facilities.

Basic Problems Besetting Clinical Research

wards just as they do in Germany, are also subject to pressure to provide professors and young physicians with research facilities.^ In spite of this politically legitimated and statutorily established status of research, the latter has still not been able to achieve a position equal to that of patient care in integrated models. Why does the care of the sick attract "all resources to itself with irresistable power..." (Sachverstandigenrat 1991: 174)? Even if, as in Germany, a certain percentage of the subsidies provided to the university hospitals by the individual states is supposed to be used for purposes of research and teaching, this does not prevent patient care from making inroads into these protected resources. For it is difficult to quantify the costs of research and teaching; as a result, allocation is not transparent. Moreover, the resources provided are not targeted, i.e., they are not granted within the framework of a separate budget (ibid.: 172-74; Schimank 1993). Two further aspects are important in this context: first of all, the hospitals become part of a coalition of interests arising out of the health care system, and secondly, the hospital administrations - regardless in which affiliation model - develop their own interest in optimizing patient care. In all three European countries, the university-affiliated hospitals are responsible for the performance of certain highly specialized tasks in patient care for a given geographical region. Being part of the health care system in this way, these facilities become subject to the authority of the responsible health department (an authority shared in France and Germany with the health insurance agencies), which establishes the financial modalities of patient care. I will show in a nutshell, by using the German example, how a coalition of interests among the administration of the university hospital, practicallyoriented clinical professors, health insurance agencies, and the responsible government departments can arise from such afinanciallinkage to the health departments and other corporate actors in the health care subsystem. This coalition shares an interest in optimizing patient care, while keeping down

26 Due to the frequently private character of hospitals, there is no equivalent to this political pressure in the United States. Within the state health care system of England, implicit government directives attempted to guide hospital actions in favor of research, though with minor success. These directives have recently been given a more formal character (see more extensively Braun 1993, Vol 1).

39

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Clinical Research: Problems and Institutional Conditions

its costs. These actors are only formally committed to giving research and teaching their due. The individual states in Germany develop a self-interest in the maximal utilization of beds at university hospitals, since, as the underwriters of hospitals, they are required to compensate for university hospital deficits. It is often the case that "revenues from hospital and nursing charges and reimbursements for services performed in university hospitals" do not cover "the ftill costs of sick care" (Wissenschaftsrat 1988: 246). At any rate, a third of the running expenses of medical facilities has to be "financed [by means of] a grant from the budgets of the state ministries of science" (ibid.: 247-248). It seems to repeatedly occur that "costs are insufficiently covered for in-patient sick care," which then "have to be covered by the states as the underwriters of the universities" (ibid.). The Scientific Council estimates that by now in many university hospitals these grants "have reached a volume far exceeding the percentage [expended] on research and teaching" (Wissenschaftsrat 1988: 264). A reduction in these grants can only be expected if there is a maximum utilization of bed capacity. The legally established responsibilities of the health insurance agencies are limited to maintaining or restoring the health of the insured, or improving the state of their health. The interest of health insurance agencies is oriented toward the economic use of their resources and satisfactorily serving their members. Thus, health insurance agencies are primarily interested in optimal and efficient patient care in German hospitals; in contrast, it is unlikely that research and teaching within the framework of a medical education play much of a role in their decisions. Considering that the expenditures made by the states for university research and teaching decreased 2.4% from 1975-1986, it is not surprising that "the financial provisions of the universities have noticeably worsened since the end of the 1970s." For the university hospitals this means that the revenues from patient care become all the more important. Only when a corresponding need for hospital and nursing charges can be proven to the states and health insurance agencies by means of an optimal utilization of patient capacity can the organization's viability and its functionality be guaranteed. If bed capacity were not fully utilized, this would probably give rise to two problems: • Conflicts could arise in the subsequent negotiations with the health insurance agencies over hospital and nursing charges, since the clinics

Basic Problems Besetting Clinical Research

41

would have to demand an increase in relative prime costs (i.e., the prime costs per patient), in order to compensate for the expected loss of patients and to finance the under-utilized departments. Such an increase in prime costs would presumably meet the resistance of the health insurance agencies. •

In such a case, one would have to expect the states not only to reduce their investment grants to university hospitals, but also, in their hospital planning, to see to what extent under-utilized departments could be closed or their tasks be taken over by other hospitals. Accordingly, not only the university hospital as a whole, but every individual clinical department is concerned to minimize such a threat by means of optimal utilization of beds.

Thisfinancing-system-inducedpatient orientation of university hospitals is, moreover, a decisive basic condition in the stabilization of a primarily patient-related action orientation on the part of the clinician. Since clinics have a special stake in attracting as many patients as possible, only those clinical specialists who are able to "attract" a sufficient number of patients are rewarded in terms of reputation and lucrative private fees. For this reason I put forth the thesis that there is hardly any actor in the health-care system who has an interest in the reorganization of this organizational pattern of financing, which is specific to German university hospitals. For university hospitals, maintaining their viability is premised upon the maximum utilization of their bed capacities; health insurance agencies can reckon with less expensive hospital and nursing charges, and the states can lower their own grants for covering the costs of university hospitals on the basis of greater utilization. And finally, private fees enable physicians to improve their incomes to a disproportionately greater extent than a research-oriented position does. In this way, resources are committed to patient care in a durable fashion. It turns out that an analogous coalition of interests in France has, for a long time, also failed to take any noteworthy steps toward promoting health research (see more extensively Braun 1993a, Vol. 2). Given such constellations of interest and allocation conditions, change can only occur if the hospitals are put under tremendous public pressure to consider research an integral part of their operations. France offers an example of this. The Institut National de la Santi et de la Recherche MMicale (INSERM; the

42

Clinical Research: Problems and Institutional Conditions

National Institute of Health and Medical Research) made an agreement with the parent organization of hospitals in Paris in the seventies to establish research at the hospitals and to share resources. Nevertheless, the situation of clinical research remained just as lamentable as in the Federal Republic. Only in 1991 was a new accord reached which reiterated the intention to establish a stronger place for research in hospital organization. Apparently, the increasing loss of reputation of university hospitals in society and politics, caused by high and rising costs, low efficiency, and mediocre services, made the parent organization willing to make such a move. Research was now seen as a means of helping the centres hospitallers unlversltalres regain their status in society( see also Arliaud 1987; Ynet 1990; Majnoni d'Intignano 1989; Alber and Schenkluhn 1992; ENA 1987). In contrast, the differentiated model of medical school-hospital affiliation possesses two advantages. First of all, since individual functions are ascribed to different corporate actors, each receives greater weight in negotiations on the mode of association. Secondly, since these negotiations are primarily based on exchange, they are able to stimulate the self-interest of hospital administrations in research. In England, the differentiated model of association between medical schools and hospitals prevails. Hospital administration is subordinate to the government's National Health Service (NHS), while universities are juridically independent and possess their own decentralized administrations. Financially, though, they are dependent upon governmental funds distributed by the Higher Education Funding Councils working under the authority of the Ministry of Education and Science. Patient wards at NHS hospitals are always run by physicians employed by the NHS (so-called consultants). However, the clinicians employed at medical schools are guaranteed the opportunity to carry out teaching, research, and patient care within the organizational framework of the hospitals. For a long time, the precise conditions of association and the allocation of resources were established within the framework of a so-called knock-forknock system. This system functioned on the basis of informal arrangements between the dean of the medical schools and the administrative director of the hospital. Within it, each side committed itself to assuming the costs incurred by all services falling within the scope of its organizational duties and also to provide these services on behalf of the other organization. Thus, though the consultants discharge some of the teaching responsibilities, they

Basic Problems Besetting Clinical Research

continue to be financed by the NHS for these services; conversely, the medical schools finance the work of their clinicians at the hospital. In principle, the English associational model makes flexible management possible in the allocation of resources among the various functions of teaching, patient care and research. Nevertheless, the contingency of whether such an informal exchange will actually arise and its dependency on the adequacy of resources represent the disadvantages of such an arrangement. Although research does gain prominence in some hospitals under the associational model, in many other cases it remains just as disadvantaged as in France or in the Federal Republic.^^ If resources become scarce - and neither the integrated nor the differentiated model of association can prevent this development - one is forced to cut back those functions in which the organization has no intrinsic interest. Arrangements can always be terminated. Thus, it is almost impossible to maintain such temporary and frequently informal arrangements in the face of financial difficulties. The main point here, however, is that such arrangements are only possible in differentiated associational models and not in integrated ones. Only in the differentiated model can there be negotiations on separate budgets; only there are corporate actors able to bargain over, and come to terms on, the modalities of the exchange. A common budget, due to its accompanying lack of transparence, runs the risk of resulting in an unplanned, asymmetrical allocation of resources, as the case of the Federal Republic shows (see also Schimank 1993). In the differentiated model, this is not possible, since each of the budgets is already earmarked for a specific purpose. Differentiated associational models are primarily premised upon structural conditions in which both the medical school and the associated hospital have decentralized decision-making authorities. Given the centralistic nature of England's model of the state, this may seem surprising. In fact, however,

27 In its 1988 report on health research, the House of Lords Select Committee drew the attention of the government to the fact that the research and teaching facilities at many hospitals left much to be desired and urgently required a stronger commitment from the Department of Health and Social Security (DHSS). Ultimately, in the course of the reorganization of the government health care subsystem and under pressure from the Committee, the promotion of research and teaching at the hospitals was more explicitly defined as the responsibility of the DHSS. It remains to be seen what the results of this will be.

43

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Clinical Research: Problems and Institutional Conditions

exchange patterns between medical schools and hospitals tailored to specific local conditions have been able to form on the basis of the vertical subdivision of the health care system into regional and local health offices and on the basis of the private legal status of the universities in the scientific field. The United States possesses an even more clearly decentralized structure. The strong position of private universities in the scientific system, which are not the benefactors of any basic-facility public funding, and the great number of commercial hospitals,^^ which compete with other hospitals for patients, underscore the decentralized decision-making opportunities of these corporate actors. Since a medical school is frequently located near to any number of hospitals, it even has alternative negotiating opportunities. Very often, associational agreements are made with several hospitals at the same time. The administrations of commercial hospitals in the United States have a much greater interest in being affiliated with a well-known university as a result of their financially insecure position and their competitive position vis^-vis other hospitals. For such an association promises competitive advantages on several levels: the work of medical-school graduate students at the hospitals lowers the costs of labor; the work of the various medicalschool departments at the hospital brings its infrastructure (laboratories and instruments) up to a highly modern and suitable level and thus improves the range and quality of its diagnostic skills; and finally, the collaboration of the medical schools' corps of highly qualified, scientifically trained physicians long represented in the United States greater attractiveness for patients and increased performance in therapy.^

28 In 1986, commercial hospitals provided 40% of all bed capacity, whereas public hospitals only accounted for 6.5%. The remaining bed capacity was found at various non-profit and reUgiously affiliated hospitals (Dohler 1990: 353). The commercial hospitals, however, clearly make up the largest single group of providers. 29 It was only the financial difficulties that arose in the health care subsystem in the 1980s that were responsible for the increasingly skeptical view, especially of insurance companies, toward the "research surplus" at hospitals. They began to limit their reimbursements for costs caused by such activities as "experimental therapies" and clinical studies. This lowered the incentives for hospitals to affiliate themselves with medical schools (see more extensively Braun 1993, Vol. 1).

Basic Problems Besetting Clinical Research

45

Thus, the self-interest of many hospital administrations in the United States in affiliating themselves with a medical school is predicated above all upon two structural conditions: first, the existence of a decentralized hospital system in which decisions on resource allocation are made at the level of the hospital itself, and secondly, a supply-side system characterized by size and competition in which affiliation can bring with it competitive advantages. Decentralized decisions about associational agreements are also possible in England. However, the small number of hospitals and universities preclude the rise of competitive conditions or corresponding incentives that would prompt hospitals to affiliate themselves with medical schools. Thus, their participation in such arrangements remains a matter of chance: it is contingent upon good relations between the deans of the medical schools and the administrative directors of the hospitals. Due to the existence of an environment so favorably structured in strategic terms, American medical schools have much greater options for having their conceptions incorporated in associational agreements than those of their counterparts in European countries. Their independent status allows medical schools to give clear priority in their negotiations to the intrinsic organizational goals of research and teaching. They are under no obligation to represent the interests of patient care in negotiations; this is the task of the hospitals. In contrast, the mixing of all three functions in one integrated unit weakens the position of research: in a situation where all claims for resources are made at the same time, research has no way of successftilly competing with the principle of the "priority of time-dependent services" when applied to patient care. The differentiated model and a corresponding environment explain in part why medical research was able to achieve such great importance at U.S. medical schools and hospitals. Nevertheless, differentiated models, even if they are combined with a competitive system of health services, are hardly a sufficient or even a necessary factor. Even in integrated models, which certainly also exist in the United States (Johns Hopkins University being a famous example), research was able to obtain a much greater share of resources than in Europe. Why? Which other institutional factors explain this? Even though there are a variety of reasons for this (such as the researchand profession-oriented tradition of U.S. graduate schools; see for this: BenDavid 1971, 1977), we only want to cite one factor of outstanding importance here: the ftill-time system.

46

Clinical Research: Problems and Institutional Conditions

4.2,2 Explaining Variations in the Role of (Clinical) Research (II): The FuU-Time System. What stopped patient care from becoming autonomous (and taking on a life and dynamic of its own) in both the differentiated and the integrated models in the United States was the full-time system (see more extensively Braun 1993a, Vol. 1). This system, which now prevails at all major American universities, initially served to free clinicians from their financial ties to the health care subsystem. This was done by offering them a full-time position at a medical school. The universityfinancinggave clinicians stable incomes and sufficient time resources to devote their lives strictly to teaching and research. In return, they had to promise to pay all income that resulted from remaining patient-related activities^ into a common fund, which was then divided up within the medical school by the dean. Up until today, the financial returns from this patient-related activity have remained marginal for medical-school staff members. It was possible in this way to reduce time expended on patient care to a minimum. Structurally speaking, this presupposed, of course, the existence of large departments with numerous staff members who were able to share patient-care responsibilities as well as a considerable number of private physicians on the hospital staff. The full-time system had several consequences: it opened up time resources for research and teaching, and it reduced the incentive of private fees to draw clinicians into patient care. The system also had structural effects on the affiliated hospitals: whereas the part-time physician with private practice and patients had previously dominated the hospital, the full-time medical school faculty, trained in the field of basic research, now assumed responsibility for everyday hospital routines. The director of a hospital ward was no longer recruited because of his or her ability to cure patients, but because of knowledge of the scientific side of medicine and the ability to translate this knowledge in ways useful for patient treatment. In most of the academic medical centers that arose in this way, a department chairperson at the medical school also assumed the position of clinical

30 Even today almost all members of the medical-school staff who work at hospitals still have private patients, but only to a very limited extent.

Basic Problems Besetting Clinical Research

47

director at the affiliated hospital. The change brought about by the ftill-time system was most aptly described in the following summary of Lewellys F. Barker's ideas (reprinted in Harvey et al 1989: 192): Although Barker believed that the services of part-time faculty were also necessary, he thought that the greatest need was for full-time physicians and surgeons trained in physiology and pathology, who, after careful observation in the wards and over the operating table, would submit the ideas there gleaned to experimental tests in laboratories adjacent to the wards.

Part-time hospital physicians (who were not part of a medical-school faculty and had long assumed a position of power within the hospital) were replaced by a ftill-time medical-school faculty. At the same time, infrastructural hospital research facilities were improved. Every hospital that was affiliated with a leading research university was provided with experimental laboratories near to its patient wards, in order to provide a spatial link between science and patient care. Nevertheless, the system has not been able to completely eradicate the fundamental difference between the physician and the scientist, a difference that the father of the full-time system, Abraham Flexner, had underestimated (Flexner 1927: 2). The full-time system was introduced despite the opposition of many physicians (see Lepore 1985). In the eyes of its opponents, the system led to the alienation of the physician from the patient and to a general dehumanization of patient care. The insufficient time that would be left for patient care was criticized. It was further alleged that the interests of the scientist (cognitive advance in his or her field) conflicted with the primary concern of the physician: to care for his or her patients (Lepore 1985: 211). In the period of affluence after the Second World War, the schism between physician and scientist was temporarily resolved in favor of scientific progress. In the present period of scarcity, debate has been revived and the predominant position of research at medical schools and hospitals has once again become a controversial issue. From its very inception money was the weak point of the full-time system.^^ Physicians with a private practice earned more money than the

31 "The most obvious sticking point of the full-time system was money: accustomed to augmenting their medical school salaries with fees from their private patients, clinicians were loath to eliminate this source of income" (Harvey et al. 1989: 193).

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Clinical Research: Problems and Institutional Conditions

physician-scientist in a ftill-time system. A medical school introducing a full-time system was thus forced to provide a salary that at least approximated the regular income of a physician, while at the same time coping with the loss of income produced by the decreasing share of private fees. Only a few medical schools were able to introduce this system in a rigorous way. Often a geographicalfull-time system was accepted, where the clinician is allowed to take care of private patients, but not permitted to have his or her own private practice outside of the hospital. Only a share of the fees then returns to the clinician. Private-fee allocation and use are regulated by a faculty practice plan agreed upon by the physicians and the medical school; it establishes the procedures and payment modalities for private fees. A quite common procedure runs as follows: the private fees are paid to the medical school and not to the clinicians themselves. The money becomes part of a pool which serves the dean as a flexible financing instrument. Using this money, the dean can do such things as support preclinical departments, initiate new training and research programs on short notice, and rent new space. Only a small share of the fees goes to the physician (on this example, see Harvey et al. 1989: 121). In another common U.S. arrangement, a maximum income from private practice is set for the physician. Any fees earned beyond this are redistributed by the medical school. Though the full-time plan was in fact less rigorously implemented than originally intended, its principle ideas were upheld: patient care should not become the predominant activity of the clinician and time resources should favor research. In Germany, even though professors are employed by the medical schools, they have far-reaching opportunities to take advantage of private fees (see the Wissenschaftsrat 1986: 21-22). No measures exist to limit time resources expended on patient care. Moreover, the structure of small departments and hospitals hardly allows a flexible reallocation of the labor time invested by the personnel .^^

32 The Council of Experts (Sachverstandigenrat) writes "Even if generally there is a proper number of positions at a hospital, the personnel in any given department or individual ward can still be of such short supply that it allows patient care, but not research and teaching to be carried out in a desirable way" (Sachverstandigenrat 1991: 174).

Basic Problems Besetting Clinical Research

49

For many years, the situation in France was comparable to that in the Federal Republic (see more extensively Braun 1993a, Vol. 2). The existing arrangements enable the bi-appartenants, i.e., the medical-school members of the hospital staff, to earn more money than other scientists, since they are paid by both the universities and the hospitals. They thus have a double income. Until today, the bi-appartenants have been able to secure revenues from the treatment of private patients. An attempt to do away with private fees in France in 1982 failed. In 1986, a regulation was introduced according to which private-fee related activities were to be limited to 10% of the time budget of these university appointees. It, too, does not seem to have had much effect. At least in France there was made an effort to create a kind of ftill-time system by means of central-government regulation. However, medical schools are much too weak in France to be able to effectively put through such a regulation against the opposition of clinical doctors. Moreover, the departments and the services at French hospitals are relatively small, which leaves little leeway for reallocation. England's system most closely resembles the U.S. ftill-time system. Given the strict organizational separation and the presence of consultants in the service of the NHS, clinicians have fewer opportunities to expend their time resources at hospitals than do their counterparts in France or Germany. Only 11 % of the clinical professors have an honorary contract with a NHS hospital. But even in this case, the time expenditure on patient care does not exceed 40% (see more extensively Braun 1993a, Vol. 2; see also Dowie 1988: 55-56). For a long period of time, no private fees existed, neither for consultants nor for professors. This very favorable situation for research is slowly being changed by the reorganization of the government health care subsystem. It is really only with the scarcity of university resources in the 1980s that the English medical school staff has been confronted with a problem of time resources. The decreasing number of positions quickly led to a situation in which ever-fewer university staff members had to manage the same or growing tasks; in this context, research was the function that suffered most under the scarcity of funds (Walsh 1991; Dowie 1987: 271; Select Committee 1988, Vol. 2: 400, 431). The full-time system can certainly be considered one of the central institutional components for strengthening the position of research at medical schools and hospitals. Even in an integrated associational model, this construct provides medical schools with the chance to stem the never-ending

50

Clinical Research: Problems and Institutional Conditions

expansion of patient care. However, an important institutional prerequisite for success are departments with large staffs that can divide up the tasks of patient care among themselves. Nonetheless, all of these arrangements suffer from one problem: the competition between the health care subsystem and the scientific subsystem. In every country, medical schools are faced by the problem that they employ actors, many of whom can pursue two different career paths: that of the curative physician or that of the research scientist. The move from scientist to physician at another hospital or in one's own practice can be made not only at a young age, but at any time. By having this option open to clinicians, science, as represented by medical schools, is placed in competition with the health care subsystem for human capital. Since the financial modalities and dynamics of both systems run their courses independently of one another in all four countries, the competition for human capital becomes intense when the labor supply becomes scarce and the opportunities for financing develop in divergent ways. England is the only country that maintained a link between the income development of consultants and clinicians into the 1980s. However, this was only possible through the nationalization of the health care subsystem and through a structural increase in the salaries of clinical professors to a level 20% higher than that of all other employed scientists (for greater detail, see Braun 1993a, Vol. 2). This situation is clearly beginning to change now in the course of the reorganization of the NHS (see Department of Health and Social Security 1989). In the eighties, one began to allow private fees to a small extent in the NHS. The formation of commercial hospital trusts has provided the hospitals with a greater variety of ways to remunerate their staff. The competitive situation that arisestfiroughthe better payment at such trusts will lead in the future to a rise in consultants' income. This puts pressure on the universities, which are currently faced with the problem of surviving a sharp reduction in their resources and thus possess no leeway at all to follow this trend in the health care subsystem. The only way for medical schools to prevent a drain on personnel is by allowing private fees. Ever more medical schools are in fact now willing to depart from their previous principles. However, given the relatively small departments in England, this has to put the protection of time resources for research and teaching in renewed jeopardy.

Basic Problems Besetting Clinical Research

51

It was only possible to introduce the full-time system with its sharply reduced private fees in the United States because the National Institutes of Health (NIH) provided immense resources for research at medical schools after World War II. The acquisition of these funds was an attractive opportunity for both the medical schools and for the clinicians on their staffs. In a period of scarce funds, which the United States also entered into starting in the eighties, the medical schools and the NIH have enormous problems in preventing an emigration of human capital into the institutions of the health care subsystem. Patient care is becoming an increasingly attractive source of income for medical schools, helping to compensate for the decreasing resources available from grants. A general shift in the composition of the revenue sources of medical schools already began in the 1970s when federal agencies began to gradually withdraw their facility grants. Incomes from hospital services increased considerably while federal grant income decreased (AAMC 1989). Medical schools attempted, however, to prevent research from being marginalized by patient care. The additional time which clinical professors had to devote to patients was equally distributed among members of the clinical staff in order to reserve as much time as possible for research. A considerable amount of the money medical doctors earned from their patient-care services was put into a general fund that the dean of the medical school could tap to support the nonclinical and research-oriented departments. In France the attempt to abolish private fees at the centres hospitales universitaires failed because of the existence of a relatively large private hospital sector. It allowed the bi-appartenants to threaten to move to a private hospital, where they would have earned considerably more money, if the fees were abolished at public facilities. Similar reasons for inactivity concerning private practice hold for Germany. Thus in a period of scarce funds, the competitive situation between the health care subsystem and the scientific subsystem weaken research-friendly constructs such as the full-time system, and considerable effort has to be spent on maintaining the merits of this system.

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Clinical Research: Problems and Institutional Conditions

4.2.3 Explaining Variations in the Role of (Clinical) Research (m): Differences in the Decision-Making Structures of Medical Departments and Hospitals. Decision-making structures for the allocation of resources in medical schools is afinalpoint which should be regarded in assessing institutional differences in the organization of clinical research. Figure 1:

Typology of decision-making structures in medical schools

Decision made by

i

Professors

Dean

FRG Yes

France USA

No

England

Braun: 4/1

In all four countries studied, universities are self-governing bodies; this can, however, take on different forms. On the European continent, on the basis

Basic Problems Besetting Clinical Research

of historical and social conditions that cannot be discussed here (see, however, Ben-David 1971), science has established strong positions of power at the universities. The result was that professors, as the holders of chairs and heads of institutes, received almost unrestricted decision-making powers and university matters were represented by a professor-dominated senate. This is what I term the professor-based model. In the Anglo-Saxon countries, though science is also self-governing, the universities have assigned far greater and more autonomous decision-making powers to deans and university presidents. This is more true for the United States than for England. In die United States, deans are not elected representatives with limited terms of office; they are university administrators who can hold such positions for many years. In contrast in England, deans are usually appointed out of the ranks of professors for limited terms of office. They do, however, have greater decision-making powers than in the latter country. The example of England teaches us that limited-term appointments can sharply restrict the actual use of the power invested in the office of dean: deans can hardly allow themselves a direct clash with their colleagues, unless they are willing to accept negative social sanctions upon their return to the ranks of the professors. Thus, for the position of dean to be powerful and independent, three prerequisites need to be satisfied: • It must be an administrative position that is secure and provided with authority. • It must enjoy the trust of the professors. • The term of office must be long enough to guarantee independence and a chance to gain the wealth of experience required for effective administration. These three favorable conditions often exist at American universities. In conjunction with the chairpersons of the different departments, these deans are able to reallocate resources, establish new professorships, and perform other similar activities.^^ It should be noted, however, that the 33 Naturally, given the strongly heterogeneous character of American university structures, there are different decision-making procedures. In some of these, other persons, such as the provost, are assigned important roles in resource allocation. Often, the highest university authority, i.e., the board of trustees, also

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Clinical Research: Problems and Institutional Conditions

dean-based model without a department system would hardly be more effective than the professor-based model. It is only because the departments are so large and hetereogenously structured that the dean is able to so flexibly administer his or her funds. The public and private universities in the United States do not differ in regard to the dean-based model. This is based on the fact that professors at American state universities are not government civil servants, but employees of the university. This enables the state universities to have enough flexibility on a decentralized level to be able to restructure positions and to allocate resources in accordance with their own organizational conceptions. The internal decision-making model of the medical schools determines the degree of flexibility that is given in the allocation of resources within these departments. The professorial decision-making model tends to commit resources indefinitely, and it is supported in this by the small size of departments. It is much more difficult to maintain such "private dominions," if an independent and large-scale administration that functions on a decentralized basis exists that is able to make its presence felt in the university as a power in its own right. A dean-based model would hardly be conceivable-and this brings us to the second dimension of the typology introduced above-if formative powers at the university were shared with a centralized state administration, i.e., if a dual university administration, part state and part self-governing, were to exist. And in actual fact, the dean-based model has only developed in decentralized university systems, whereas in France and Germany state administrative intervention and professorial self-government go hand in hand. University administrations that find themselves caught between the bureaucratic-centralist intervention of state authorities and professorial self-government have especially little leeway to flexibly structure medical schools. France offers a case in point. In France, the ministry of education exercises central financial control, makes decisions in personnel- and work-related matters, and defines the general policy toward higher education. No opportunity is afforded

has to approve the appointments of new professors. Nonetheless, deans hold a key position everywhere, even if they do not make the final decisions (see also Ruegg 1985: 81-85).

Basic Problems Besetting Clinical Research

55

universities to make independent decisions on student admissions. The actions of the administrative decision-makers at the university, who are subject to government jurisdiction, are strongly marked by the administrative logic of cost efficiency (Ben-David 1968: 46; 1971: 104; see more extensively Braun 1993a, Vol. 2). The administrations in such bureacratic-centralist models function to carry out the decisions of the self-governing body of professors or those of political interests. Accordingly, their powers are very restricted. Since professorships are agreed upon in negotiations involving the self-governing body of professors and the ministries, university administrations have no chance to implement reallocation schemes in such systems. The United States represents a country at the opposite end of the spectrum from such a model. Such dualism of state and university administration is not found in its private or its public universities. Though the department of education of each state decides upon appropriations for public universities, all other university interests are represented by a board of trustees, which is appointed by the government at state universities and consists of leading figures from public life. With independent authority, it watches to see that the university administration reconciles university goals not so much with the interests of the government as with those of the public (Ruegg 1985: 38).

This leaves the American university system largely free from political intervention; on this basis, each university as governed by its own administration develops a sense of responsibility for its own actions. An entrepreneurial mentality (described at length by Ben-David 1971) arises from these structural conditions, which is reflected in the strong sense of identification of administrators with the interests of the university (see also Ruegg 1985: 38). The entrepreneurial model is characterized by extensive decision-making opportunities at the university level, by a large and independent administration, and, in many cases, by the constant necessity to acquire outside ftmding. Since institutions are not guaranteed public funding for their basic facilities, decision-makers in this model are forced to develop strategies for seeking out those resources that promise the greatest and longest-term utility for the organization.

56

Clinical Research: Problems and Institutional Conditions

Even public universities in the United States are forced to develop such search strategies. Though public financing provides the foundation for the basic maintenance of institutional facilities, it cannot cover the costs of expansion prompted by competition with private universities. American universities are constantly competing for students, scientists, and grant-dependent resources. Only the status as a center of excellence guarantees success. But such a status can only be achieved by employing such features as an attractive infrastructure and a differentiated pay scale to draw the best scientists and students. In the United States, both public and private universities acquire the funds required for such endeavors from research grants. The enormous, post-World War II expansion in biomedical and clinical research was only possible by means of the grants economy, i.e., an immense expansion of grant-based research funding. This enabled the medical schools to free themselves from patient care as a modus of financing and finance their organizational needs to a large extent via grants. As discussed above, this provided the decisive prerequisite for strengthening the research function of medical schools. The grants economy contributed to the success of the entrepreneurial model in several ways: • In contrast to their European counterparts, American funding organizations provide an indirect cost award, which at some centers of excellence accounts for up to two thirds of total revenues. A major share of university infrastructure can be financed in this way; • Grants allowed universities to reduce the level and number of regular salaries paid. Scientists themselves are expected to supply a certain percentage of their income by means of grants. In this way, public universities are able to increase the number of existing, fixed trajectories of established salary lines set up for personnel; • Grants provide deans with an outstanding tool for monitoring the research performance of their scientific staff: the sponsors' grant-approval procedures serve as a selection process for "separating the wheat from the chaff." Scientists who are unable to acquire sufficient grant-based resources need not fear dismissal, but are subject to cuts in resources and shifts in departmental assignments after a certain period of grace. Thus, in the United States, grant acquisition is used as an organizational selection principle.

Basic Problems Besetting Clinical Research

57

The combination of a politically independent university administration, the dean-based model as internal decision-making model, large departments, and a grants economy provided the foundation for the rise of a research-oriented entrepreneurial model at U.S. medical schools. The tendential decrease in grant resources in the eighties was, however, accompanied by a ~ though only gradual - reorientation toward patient care. At least in the case of medical schools, a decrease in research resources can be responded to by a greater concentration on patient care or by (increased) tuition fees. As in any economic enterprise, the entrepreneurial model is only dependent on any given product to a limited extent (i.e., in relation to past investments). It is precisely the organizational multifunctionality of medical schools that provides the dean with the opportunity to make shifts in the relative weight of the various functions, if organizational viability requires this. Thus, the entrepreneurial model provides medical schools the opportunity to carry out research as long as sponsors continue to offer visible, externally based financial incentives. However, in the absence of such incentives, medical schools are forced to change their orientation. In England, the dean-based model and decentralized organization prevail. Nonetheless, the research situation there differs from that in the States. Decision-making powers and reallocation opportunities are much more limited at English universities. The small departments give professors more prominence. The heterogeneity of these departments is also limited. Above all, however, there is nottiing comparable to the competition and decentralization of the American system. In England, in spite of the legal autonomy of the university, its financial dependence upon government resources gives political authorities the chance to exert influence. Although almost no interventional powers are directly linked to this dependency-related advantage, the government is nevertheless able to reach a kind of "contextual control" by means of budget cuts and conditions of financing. In the eighties, this caused medical schools to agree to adapt organizationally in accordance with government guidelines. Thus, as a result of their funding ties, English universities are unable to avoid the strictures of government science policy. This basic funding makes the incentive to acquire resources from other sources significantly lower than in the United States. Moreover, there is a great deal less grant money available in England. And finally, for all

58

Clinical Research: Problems and Institutional Conditions

practical purposes, patient care does not represent an alternative means of financing medical schools. In summary then, the entrepreneurial model and the greater flexibility it provides medical schools cannot be achieved simply by establishing the university's independence from political-administrative intervention and a dean-based model. It also requires a competitive system on the scientific market among a large number of service providers and extensive resources that can be competed for.

4.3 CONCLUSION

Table 2 summarizes those factors that can be considered institutional advantages for establishing clinical research since they are capable of decisively influencing the allocation of time and other resources in a way which is favorable for the research function.

59

Basic Problems Besetting Clinical Research

Table 2:

An overview of favorable institutional conditions for clinical research

USA

FRG

France

England

II Differentiated model

1

0

0

1

1 Decentralized II structure

1

0

0

1

1 Competitive system

1

0

0

0

1 Graduate School

1

0

0

0

1

0

1

1

Dean-based model

1

0

0

1

Political independence

1

0

0

0

1

0

0

0

Reduced private

1

1 fees

1 Large department

1

1 indicates that the institutional structure exists in the country in question; 2 that it is absent.

Let US now define the factors listed in the table: A differentiated model refers to an associational structure between the medical school and hospital that is characterized by the separate organization and administration of patient care, on the one hand, and research and teaching, on the other. Both the hospitals and the medical schools are independent corporate actors which periodically renegotiate their form of association. Decentralized structure points to the ability of medical schools and hospitals to independently make organizational decisions, unimpeded by the centralist interventions of government. Centralized structure, by contrast, is marked by the ability of governmental authorities to set

60

Clinical Research: Problems and Institutional Conditions

organizational policy guidelines and to reserves for themselves the right to make final decisions on matters of administration, personnel, and financial policy. We speak of a competitive system when there are a large number of hospital-service providers in the hospital field and of universities in the scientific system whose revenues are not guaranteed by public, basic-facility funding. These organizations enter into competition with each other for resources. Two criteria govern my use of the term graduate school: the high priority generally given to research at such institutions (in the United States: the Ph.D. as status symbol; cf. Ben-David 1977) and the tradition of professional orientation in scientific training, which defines the translation of scientific knowledge into application as a task of the graduate school. Both of these criteria are only fulfilled by the United States. England possesses the tradition of professional orientation in scientific training, but the research profession does not enjoy the same high status there that it does in the United States. In the Federal Republic, scientific training is traditionally the domain of the universities, but professional training has been removed from it. The situation is similar in France, where there is a much greater professional orientation to training at the Grands Ecoles than is possible at the university. Reduced private fees are found in three of the four countries. Even though the scope of private fees can vary, especially in the United States and England, as a result of the heterogeneity of university structures of both countries, the use of this term denotes that, on average, not more than 10% of time resources are expended on their acquisition. The dean-based model points to an organizational tradition of a strong and independent administration in medical schools, which is able to make decisions in conjunction with, and sometimes over the heads of, the professorial staff. Whereas in England one finds a sharply weakened dean-based model, in the United States a strong version is found. Dean-based models exist in the absence of administrations with bureaucratic-centralistic orientations. The latter emerge out of a dualism between state- and self-administration. When such conditions are absent, an entrepreneurial model of university administration can develop, which can be crucial in the flexible adjustment to environmental changes. Whereas American and English universities resemble one another in regard to the dean-based model and the unified character of university

Basic Problems Besetting Clinical Research

61

administration, they do differ in terms of their dependency on the public provision of basic-facility funding. The entrepreneurial model has no chance in England as long as the university is largely dependent on government resources and lacks alternative means of financing. In contrast, in American public universities, dependence on public financing did not impede the development of an entrepreneurial model, since these institutions are embedded in a competitive system and numerous means of alternative financing exist. • It was often cited that large departments are an important prerequisite of the ability to flexibly allocate time resources among department staff members. Given their hetereogeneity and size, they also have the advantage of allowing a diversification and specialization of scientific disciplines. Thus, they not only have the effect of promoting more flexible time allocation, but, in institutional terms, they are also advantageous for innovative scientific development. My research findings in England demonstrated that a department structure per se does not offer enough advantages to strengthen the research function, in spite of its more egalitarian orientation. A diversification of research and a more flexible structuring of time budgets can only be provided for if there are a sufficient number of positions. The presence in one country of all the institutional conditions cited can contribute to an improvement of the position of theoretically guided clinical research within the organizational context of hospitals and medical schools. However, this does not mean one can speak of a deterministic causal mechanism. Institutional conditions solely offer a favorable framework for the individual decisions of research-minded clinicians and biomedical scientists on the one hand and patient-minded clinicians on the other to cooperatively contribute to clinical research. The United States no doubt offers clinicians the best opportunities and the most incentives for engaging in a scientific approach to clinical research, whereas Germany and France are the least attractive in these terms. England is located somewhere between these two variants, since the organizational structure of academic medicine there resembles that of the United States in some points (differentiated model, decentralized structure, reduced private fees, dean-based model). The example of England shows that these opportunities were sufficient for establishing relatively successful and internationally recognized clinical research, at least into the seventies, i.e.,

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62

Clinical Research: Problems and Institutional Conditions

until it became necessary to incorporate the findings of molecular biology into clinical research. An important additional factor in this success was the availability of sufficient resources and positions in this period, which meant that diversification and increased flexibility within the departments did not create great difficulties. This is precisely what changed in the eighties (in a period of scarcity) and laid bare the limits of the English system. The differentiation of roles that are organized in different social subsystems may be an unavoidable tendency. Nevertheless, an integration of these roles - whether by being combined in one person or by the cooperative efforts of those playing the roles - is certainly within the realm of institutional possibility. It was above all in the United States that these dissociating elements were successfully kept under control. There are a whole series of reasons as to why this was possible there, attributable to the structure of the historically evolved scientific system and its relationship to political authorities as well as to several special institutional factors. In its combination of factors that are favorable for research in general and clinical research in particular, the United States very likely represents a special case, which, given the similarity of its traditions in science and educational policy, only England even approaches. Differences in the institutional conditions of the research systems of the United States and European countries result in divergent consequences for the sponsor of research: the innovativeness and adaptability of the American scientific system provides him or her with a very high and spontaneous capacity to compensate for undesirable developments. Funding mechanisms still have to be made use of, but this can frequently be done with less cost and the intervention need not make the qualitative changes that are required in the case of European countries, where rigid structures and concomitant interests in maintaining them compel funding agencies to be especially forceful if they hope to be successful.

PART 3 THE ROLE OF FUNDING AGENCIES IN HEALTH RESEARCH

5.

AN INTERNATIONAL COMPAWSON OF HEALTH FUNDING SYSTEMS

In the last chapter, the different ways in which clinical research has been organized institutionally were presented. In this context, the United States distinguished itself positively from the European countries. Because of several institutional factors it seems likely that the transfer of basic biomedical knowledge into clinical application is more aptly realized in the United States than in the European countries. This does not mean that differentiating tendencies which are present in the development of health research, have been successfully combated and eliminated. Financial strains challenge the existing, favorable institutional arrangements for health research even in the U.S. Rather, what has been achieved in the United States is an institutional order which can at least temporarily counterbalance these tendencies by providing interactive facilities favorable for coordination and communication between scientists and clinicians. The existence of these opportunity structures account for the important role of biomedical-oriented clinical research. In this chapter and the next, I will concentrate on the second decisive factor accounting for differences in the performance of clinical research, i.e., the individual role XhdX funding agencies^ their strategies and instruments, have played in supporting health research in general and the transfer of basic knowledge into clinical application in particular. A substantial part of policy formulation and implementation in research policies in OECD-countries is dealt with by public or semi-public funding agencies (OECD 1991: 7-8). They are, the OECD claims, pivotal organizations where scientific and political interests are transformed into research policy programs and put into action. It is because of the role of these intermediary organizations that research policymaking has a decentralized character in many countries (ibid.: 23). Once the government has decided upon the amount of money to be appropriated to the broad research areas (such as defense, health, or agriculture), the funding agency often enjoys considerable autonomy in determining by what means and to what specific research areas the appropriated funds will be distributed. The task of funding agencies is to allocate the resources for research in such a way that international competitiveness is achieved, the most promising scientists and institutions are supported, underdeveloped scientific fields are developed, and the transfer of basic knowledge into areas of application is

66

The Role of Funding Agencies in Health Research

accomplished. In many instances, therefore, they translate political controversies according to their own needs, perceptions and functions. Without any exaggeration one can, therefore, state that funding agencies are the relevant corporate actors who deal with the maladaptatedness, inflexibility or unproductivity of scientific research. Accordingly, any discussion of the adaptive powers of national scientific systems must take into consideration both the self-adaptive capabilities of science and the guiding and reforming potential of ftinding agencies trying to cope with the failure of, in this case, health research performance. The achievements of funding agencies in health research are dependent on: • First, their ability to find a demand for their funding resources. This is determined by the amount of funding resources available, the competition with other funding agencies, and the willingness of investigators to apply for funding resources. • Secondly, on the capability of funding agencies to cope successfully with the conflicting demands of political and scientific actors in developing funding strategies. • Thirdly, on their instrumental capabilities. Differences in terms of these three dimensions influence the room for maneuver of funding agencies and, hence, their set of strategic alternatives in funding policy. Funding agencies with a restricted room for maneuver are not expected to contribute to an improvement in the adaptive capacities of health research. On the other hand, those with sufficient funding resources, a high demand for resources on the part of investigators, a monopolistic position in the funding system, little intervention in their affairs on the part of policymakers, and a rich and variable set of funding instruments are very likely to contribute to positive changes in health research.

International

5.1

67

Comparison of Health Funding Systems

GENERAL CHARACTERISTICS OF FUNDING SYSTEMS IN HEALTH

RESEARCH

In the following table one finds basic differences in the expenditure behavior of the four countries in question with regard to research and development in general and with regard to biomedical research in particular.

Table 3:

The financing of research and development in four countries

1

1

Year

USA

Germany

France

England

1984

1

1988

2.92 2.86

2.71 2.83

2.25 2.29

2.20

1

1988

48.3 48.8

36.7 33.9

52.9 49.9

36.5

1

1988

50.0 49.2

61.8 64.1

41.4 43.3

1

1988

10910 14905

4889 5540

2924 3971

2660

II

1 BIOMED 11

1987

7285

1483

1116

864

II

Variable GERD

GOV

1985

1985

IND

1985

GOVEXP

2.31

1

43.4

II

46.0

51.4

1

2303

GERD represents the national expenditures on research and development expressed as a percentage of gross domestic product (source: OECD 1990/2: 17, Table 5); GOV represents the percentage of national expenditures on research and development provided by the government (source: OECD 1990/2:20, Table 14); IND represents the percentage of national expenditures on research and development provided by industry (source: OECD 1990/2: 20, Table 13); GOVEXP represents government expenditures for research and development in millions of U.S. dollars (source: Irvine et al. 1990: 214); and BIOMED represents national expenditures on research and development in biology and medicine in millions of U.S. dollars (source: Irvine et al. 1990: 219).

Germany and the U.S. are the leading countries in research expenditures expressed as a percentage of the gross domestic product. The countries demonstrate remarkable differences in the relationship of private and public funding of research and development: France and the U.S. are what one could call "state-financed research systems" while England and Germany in particular exhibit a high percentage of industry-financed research and only

68

The Role of Funding Agencies in Health Research

a moderate engagement of the state in the financing of research and development. When it comes to government funding directed to biomedical research, the United States is without doubt the leading country in the world. Almost 50% of government expenditures on research and development are spent on health research, which in 1987 translated into $33 per capita (Irvine et al. 1990: 219). Germans spent $24, the French $21, and the British only about $15.^^ In the United States, the federal government financed 83% of all university biomedical research expenditures in 1987, while industry accounted for only 6.7% (see National Academy of Sciences and Institute of Medicine 1990: 2). The support for medical and health-related research and development within the federal government is distributed among several departments,^^ though the Department of Health and Human Services (DHHS; 81.1 % of all federal health research expenditures) - and within this department, the National Institutes of Health (NIH) (72.6% of all federal health research expenditures) - is the major agent for the funding of biomedical research in the political system.

34 Research expenditures on the life sciences as a percentage of overall research expenditures amounted to 48.9% in the United States, 36.7% in the Federal Republic, 34.7% in France, and 30.9% in England (see Irvine et al. 1990: 219). 35 They include the Departments of Agriculture (1.1 % of all federal health research expenditures), Defense (7.2%), Education (0.6%), and Energy (2.4%), the Environmental Protection Agency (0.5 %), the IDCA (0.4%), NASA (1.9 %), the National Science Foundation (1.2%), and the Veterans Administration (2.7 %). The last of these organizations (now the Department of Veterans Affairs, with its own Veterans Health Services and Research Administration) is important because of its facilities for clinical research. This department owns more than 400 hospitals, which are often situated near medical schools. Emphasis has been placed on clinical research in the postwar period, and this department only ftmds investigators at its own institutions.

International Comparison of Health Funding Systems

NIH is a federal agency of the Public Health Service (PHS) section of the DHHS.^^ The PHS includes all major agencies responsible for public health and biomedical research activities.^^ NIH is not only the most important extramural funding agency; in terms of employees, it is the largest of all government agencies (13,250 positions of full-time equivalent employment in 1988; Hearings 1989a: 104). In 1988, NIH alone financed 71.6% of all university-based biomedical research. It is safe to contend that NIH (and to a lesser extent, the former ADAMHA which was focused on the three areas of alcohol, drug abuse, and mental health) is the agency within the federal government that is the most active in intramural biomedical research and in extramural funding of biomedical research.^^ NIH must be regarded as the crucial authority in the development of biomedical policies in the United States.^^ In principle, the

36 The Public Health Service combines with the Office of Human Development Servicesy the Health Care Financing Administration, the Social Security Administration, and the Family Support Administration to make up the DHHS. 37 It includes the Agency for Health Care Policy and Research (AHCP); the Centers for Disease Control (CDC); the Food and Drug Administration (FDA); the Health Resources and Services Administration (HRSA); the Agency for Toxic Substances and Disease Registry, the Indian Health Service', and NIH. Until 1992, it also included the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA), the research institutes of which are now incorporated within NIH (these research institutes are the National Institute of Mental Health, the National Institute on Drug Abuse, the National Institute on Alcohol, Abuse and Alcoholism). Meanwhile, a new agency, the Substance Abuse and Mental Health Services Administration, has been founded to deal with prevention and treatment. 38 Intramural research denotes research activities conducted within the funding organization itself. Extramural funding refers to the activities of funding agencies dedicated to the improvement of research in other research organizations, such as universities, for instance. 39 Without any doubt critics are right to state that "the federal health policymaking structure in the United States is fragmented" (Feingold and Greenberg 1984: 99). This is a valid statement for an array of different activities (such as extramural funding activities. Medicare, Medicaid, and public health activities). These activities are often institutionalized in different departments and government

69

70

The Role of Funding Agencies in Health Research

three Institutes of the ADAMHA have functioned in precisely the same way as the 14 Institutes of NIH. Even when they were still two different organizations, in their relationship to extramural funding and intramural research, they could be considered as a single entity. NIH has the mission "to improve the health of the American people 'by increasing our understanding of the processes underlying human health and by acquiring new knowledge to help prevent, detect, diagnose, and treat disease'" (Raffel and Raffel 1989: 295). Cooper and Bennett (1983: 95) identify four major areas of activities of NIH: science base, clinical application, transfer of knowledge, and training. Raffel and Raffel (ibid.) add to this list the NIH task of ensuring the existence of "adequate research facilities." These broad areas of activities define the general framework within which the more specific and often categorical activities of the now 17 Institutes of NIH take place."^ All Institutes were constituted by a separate legislative act in Congress that also defined their specific activities. Even though every Institute has its own field of activity, there may be some overlapping. For example, research on Alzheimer's disease is promoted by the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Aging (NIA), and the National Institute of General Medical Sciences (GMS). However, they never jointly fund any project. The individual Institutes of NIH vary in size. The National Cancer Institute (NCI), for example, expends the greatest single share of NIH funds (in 1990, $1,634 million; that is 21% of all NIH ftinding; on these figures, see NIH 1990: 7). It is followed by the National Heart, Lung, and Blood

administrative agencies, and inter-agency coordination appears to be poor (ibid.: 100). Activities with regard to biomedical research, however, are quite concentrated within NIH and ADAMH A, making fragmentation a somewhat less urgent problem. The incorporation of the major part of ADAMHA within NIH in 1992 served to further concentrate these activities. 40 There are three Institutes whose missions are not defined in terms of a specific disease: the National Institutefor General Medical Studies (GMS; basic research in general); the National Institute on Aging (NIA), and the National Institute on Child Health and Human Development (NICHHD).

International Comparison of Health Funding Systems

71

Institute (NHLBI; $1,072 million) and the National Institute of Allergy and Infectious Diseases (NIAID; $833 million). Borrowing from the jargon of economists, I believe that we can characterize the U.S. biomedical funding system almost as a monopoly, i.e., as a system in which only one supplier meets a large number of consumers, though there are, in fact, additional minor suppliers. In terms of its funding expenditures, the otherwise important National Science Foundation (NSF) only plays a subordinate, though in no respect an unimportant role in basic biomedical research. In addition, there are a number of larger and smaller foundations, nonprofit health care associations, and different federal and state agencies active in biomedical research. They, however, cannot in any way contest the predominance of NIH, even though a foundation like Howard Hughes (with a budget exceeding $300; Howard Hughes is active in basic and clinical research) or the rich Rockefeller Foundation (which is promoting above all public health research) plays an important role in the development of fields of health research. Given this central position of NIH in the American health funding system, financial developments that affect NIH will thus have direct repercussions on biomedical research. Research scientists and administrators at medical schools have only a very limited choice of alternatives to compensate for any losses in NIH funding. In France, the Centre National de la Recherche Scientifique (CNRS) is the most influential research and funding agency. However, in terms of total expenditures in the biomedical field, the Institute National de la Sante et de la Recherche MMicale (INSERM) is of at least equal significance. Both agencies are semi-public organizations with a special legal status, so-called etablissements publiques scientiflques et technologiques (EPST). In 1991, both organizations expended about Fr 2 billion, i.e., about $400 million in the biomedical field. Overall, CNRS controlled 22% of all French government expenditures on research and development (Fr 11 billion). In financial terms, INSERM is much smaller, accounting for Fr 2.1 billion or 4.3% of these same expenditures. CNRS spent 23.2% (Fr 1.726 billion) of its budget on its division for life sciences {sciences de la vie; CNRS 1988). This division is the largest one at CNRS, with 69 of its own research units, 224 associated research units, and

72

The Role of Funding Agencies in Health Research

52 research teams (groupement de recherche)^^ About 3,000 researchers are employed there in the fields of biological and medical research and 4,860 researchers from other organizations/^ Most of the expenditures in this division go to salaries (Fr 1.327 billion). Only Fr 400 million are targeted to infrastructure. Applied medical research remains underdeveloped at CNRS. The focus of interest at CNRS has been and continues to be on basic research in the biosciences, even though about 20-50 research units maintain some type of relation to clinical research. INSERM was founded in 1964 by physicians and the Ministry of Health to eliminate the lack in clinical research engagement found at CNRS. Though the application of the findings of basic research in a clinical context represents the primary aim of INSERM, for many years the focus of its research activity was more on basic research than on its application. In 1982 a renewed effort was made to strengthen clinical research both inside and outside of INSERM. INSERM itself claims to now devote 24% of all of its activities to clinical research (INSERM 1989a: 78). Basic research, however, continues to play a vital role in its research undertakings. In 1991, INSERM spent Fr 2.12 billion on medical research. In 1990, INSERM financed 246 research units (Projet de Loi de Finances 1990: 132), of which 121 were placed either at institutes near hospitals or

41 One should mention that in France there is no tradition of extramural funding comparable to that of the United States. For historical reasons that need not concern us here, research takes place not only at universities but above all at nonuniversity institutes, the so-called grand organismes, CNRS and INSERM are examples of this type of organisation. Their main task is to organize and finance research intramurally, i.e., within the confines of their own organizations. Most of the time this is accomplished by placing their research teams within a university setting. University researchers may participate within these research teams. On a minor scale, CNRS and INSERM are also active in supporting university research by means of grants. 42 These consist of so-called chercheurs equivalent a temps plein (ETP), scientists from other research institutes and universities, and boursiers, post-graduates with research fellowships.

International Comparison of Health Funding Systems

directly at the hospitals themselves (INSERM 1989a: 8)/^ Of the research units, 60% (102 units) are located in the greater Paris area. CNRS and INSERM administered about two thirds of all government expenditures in this way, while the remaining third was spread among a whole series of other nonuniversity and government financed facilities (particularly, the Institut Pasteur) and among the universities (as a basis for comparison, see Irvine et al. 1990: 219). There is no doubt, however, that it is INSERM which takes the most prominent position in promoting the transfer of basic knowledge into clinical research. The promotion of health research in England was, until 1993, primarily funded by two government-level departments: the Department of Health (DoH) and the Department of Education and Science fDES).'*^ The DoH has the mission of promoting the health of the general population and organizing and administering the national health care subsystem. Funding is made available for research projects in both areas, totaling about £30 million. The DES was responsible for the funding of schools, technical colleges, universities, and the promotion of science. The actual funding of research was not implemented by DES, but by research and funding councils outside of the Department. The two departments have had differing interests in research funding: for the DES, it only represented one task among many others. It hardly had any specific, substantive interests in realizing definite research goals. The DES considered the cost-effective and structure-optimizing support of the educational and scientific systems its primary aim. It remains to be seen, whether the new established Office of Science and Technology, replacing the DES in the promotion of research funding, will demonstrate more ambitions concerning research policy formulation. The Office was set up in order to

43 The Projet de Loi de Finances states that 94 INSERM research units were placed near hospitals and 82 were placed at universities in 1990 (Projet de Lx)i de Finances 1990: 132). 44 In 1993 the Office of Science and Technology, located at the Cabinet Office, obtained the authority to administer the funds distributed to Research Councils, in place of the DES. However, since the figures presented here refer to previous years, my discussion will be in terms of the DES.

73

74

The Role of Funding Agencies in Health Research

coordinate government efforts in the promotion of science and realize more ambitious aims of the government concerning future research developments (see: Realising our potential 1993). In contrast, the DoH - due to the field of its administrative activities and authorities - has its own specific interests in the results of health research funding, for example, to acquire scientifically based knowledge on future actions or to gain knowledge on health problems which the Ministry has to cope with. There was hardly any coordination between the DoH and the DES on questions of research. The points where the two departments came into contact primarily involved the funding of some of the more indirect preconditions of medical research, such as the costs of medical education. National Health Service (NHS) hospitals, and the operation of medical schools. Whereas the DoH is responsible for the number of medical students and their education, and the number of physicians and hospital services, the DES still finances the salaries and infrastructure of the medical schools. There is an interdepartmental committee that is supposed to help coordinate activities. Nevertheless, a series of problems in research can be traced back to a lack of communication between the two departments (Select Committee 1988, Vol. 2). A considerable share of the resources of the DES went into medical research, both by means of the basic-facility funding of the universities as administered by the University Funding Council (UFC; now called the Higher Education Funding Councils) and via the intramural research and extramural funding of the Medical Research Council^^

45 In all, there were five such Councils: the Agricultural and Food Research Council (AFRC; 8.3%), the Economic and Social Research Council (ESRC; 3.7%), the Medical Research Council (MRC; 20.6%), the Natural Environment Research Council (NERC; 10.8%), and the Science and Engineering Research Council (SERC; 53.1%). The percentages given for each Council refer to its share of the total budget granted to the research councils by the DES in the fiscal year of 1987/1988 (ABRC 1987: 22). In 1993 some changes in the outlook of the Councils have been introduced by the government. At the moment (i.e., autumn 1993) the SERC is in the midst of being replaced by an Engineering and Physical Sciences Research Council and a Particle Physics and Astronomy Research Council, At the same time, the AFRC is being incorporated into a Biotechnology and Biological Sciences Research Council,

International Comparison of Health Funding Systems

As in France, research councils are nonuniversity institutes responsible for intramural research and extramural funding of university research (the latter on a major scale in comparison to France). Extramural funding is of greater importance to English research councils than it is to the grands organismes in France: the MRC spends approximately two thirds of its budget in support of university research and education. The total amount of fimds administered by the University Funding Council (UFC) for purposes of research was about as high as that of the Research Councils (ABRC 1987: 27). According to plans, the funds allocated for research (£105 million) and teaching (£186 million) at medical schools were supposed to total £291 million in 1988/1990 (ABRC 1987: 4).. Of the approximately £620 million that the DES allocated to the Research Councils as a whole in 1987/1988, the Medical Research Council (MRC) received 20% and thus represented the second largest Council following the Engineering Science Research Council (ESRC; see ABRC 1987: 20, 27). It plays the leading role in the allocation of government funds for health research in England. Expenditures for the budgetary year 1991/1992 are estimated at circa £220 million, the equivalent of approximately $400 million. Though other research councils also administer some health-research funding,^ none comes even close to the MRC in importance. The MRC is an organization with approximately 3,500 full-time employees and 440 part-time positions. In 1989/1990, the staff included 894 scientists, 156 physicians, 1,213 technicians, 600 administrators, and 184 other employees (MRC 1990a: 68). Though the MRC is clearly the most important government funding organization for basic biomedical and clinical research, its position is contested by private foundations. In contrast to Germany or France, the foundations in England play a major role in the funding system. They provide roughly the same level of funding for medical research as does the MRC (£177 million in 1989/1990 versus £192 million from MRC; see MRC 1990a: 54). Moreover, since a large share of funding is awarded in the form

46 The MRC promotes the development of biomedical and clinical research; SERC funded basic research in biology, pharmaceutical research, and, above all, biotechnology and its industrial development (Select Committee 1988, Vol. 1:9); and ESRC supports social-scientific health research.

75

76

The Role of Funding Agencies in Health Research

of grants (ca. 60%), the foundations are especially important for medical schools and hospitals. This convergence of the relative financial weight of foundations and the MRC is a trend of the last 10 years: while numerous foundations were able to raise the level of their expenditures by means of increased contributions, successful market-investment strategies, or additional revenues from commercial enterprises, the MRC had to learn to cope with less money (Braun 1993c). Thus, the influence of a contracting public system of financing on the MRC, coupled with a simultaneous expansion of the financial opportunities of the foundations, resulted in a shift in the relative strength of the actors in the British health ftmding system. The Wellcome Trust (WT), with total expenditures of over £200 million in 1993, has become an important competitor of the MRC. In the field of cancer, the foundations specializing in this disease (the Imperial Cancer Research Funds^ ICRF, £44.8 million in 1989/1990; and the Cancer Research Campaign, CRCa, £35.5 million in 1989/1990) even represent the most important source of funding for researchers. The changed conditions in the funding system brought about the first meeting between the MRC and the Association of Medical Research Charities in 1991 in order to coordinate several aspects of ftmding policy. Up until that time, both sides disregarded the other in choosing their strategies. As long as the MRC was in the position to design its research funding program according to its own conceptions, it had no reason to push for coordinating efforts with the foundations. Coordination would have presupposed a readiness to compromise and thus limited one's own freedom of action. Moreover, aside from the major foundations, there was no corporate actor with whom one could have coordinated actions. The relationship with the WT, which funded in the same fields as the MRC and at a significant level of expenditure, was marked more by competition than by cooperation. The other two major foundations, the ICRF and the CRCa, concentrated on the field of cancer, which the MRC had always considered a lower priority in its overall funding program. It was only when the AMRC developed into a unified corporate actor who could serve as a discussion partner for the MRC that negotiations of mutual advantage emerged as a distinct possibility.

International Comparison of Health Funding Systems

11

Germany differs from the other three health funding systems in two respects: First, there is a clear division between political health research funding and scientifically organized health research funding, with both sides showing considerable strength. Secondly, the organization of political research funding is internally differentiated along the lines of intramural research and extramural funding, though biomedical research policies are designed by a single corporate actor, the German Federal Ministry of Science and Technology (BMFT; Bundesministerium fiir Forschung und Technologie). The funding of basic and strategic research with federal funds runs into strong and profound objections from research and funding institutions based in the scientific community, namely from the German Research Society (Deutsche Forschungsgemeinschaft; DFG) and the Max Planck Society (Max-Planck-Gesellschaft; MPG). The DFG is an all-around funding agency distributing only extramural funds. In contrast, the MPG receives annual fiinds from the federal and states governments for conducting overwhelmingly intramural research. Following the war these corporate actors were able to claim the promotion and conduct of basic research as their exclusive domain of action (Mayntz 1991). When the German Federal Ministry for Science and Technology was founded in 1972, it faced the strong veto powers of these institutions, which were strengthened by the reluctance of the Ldnder (hereafter: states) to concede the federal government the right to substantial research activities of its own (see also Hohn and Schimank 1990). Since 1982, the year the conservative government coalition came into office, the principle of subsidiarity in research funding characterizes the relationship between political extramural research funding and DFG funding: From the outset, the DFG and the BMFT have sought to sponsor research in a mutually complementary fashion by establishing respective fields of funding jurisdiction, i.e., distinguishing between basic-science research (DFG) and applied research (Federal Programs). In its so-called Gray Plan of 1987, which outlines basic strategic areas of extramural funding, the DFG makes jurisdictional domains and their possible overlapping areas clear in this regard:

78

The Role of Funding Agencies in Health Research

Due to their importance for health policy, certain areas of application-oriented, clinical research"^^ receive large-scale funding (as governmental research) from the BMFT and the Health Ministry, especially within the federal government's research funding program "Research and Development in the Service of Health." In accordance with the defined purposes of these resources, the dividing line between it [the field of their use - trans.] and clinical research in the narrower sense, i.e., the analysis of pathological phenomena with natural-scientific methods as funded by the DFG, is also to be maintained in the future. As in the past, this does not exclude common programs with two-fold objectives in the two fields. (DFG 1987: 168) Up until now, efforts have been made to largely maintain this division of labor or demarcation of domains. Thus, DFG representatives take part in peer review meetings of the Federal Program; plans for new target areas for Federal Program funding are first sent to the DFG for comment; and on topics in borderline areas of jurisdiction, the DFG is asked if it would like to fund such a target area of research. In the same way, the DFG refers grant applicants in appropriate cases to the political funding agencies. Political sponsors can take part in symposia on the establishment of target areas or of the funding instrument for special research fields (SRF) of the DFG, and naturally, there are also political representatives on the main committee of the DFG. Subsidiarity in research funding, however, can be very time-consuming in a health funding system like that of the Federal Republic, in which there are only a few major funding organizations. For example, the BMFT might not be able to make a decision on the establishment of a new target (or priority) area for research funding, since, in terms of the subsidiarity principle, such a topic would actually fall under the jurisdiction of the DFG; thus, it first has to be settled whether the DFG would like to establish its own target area instead. Such decisions can take some time, since the DFG senate, which is responsible for such decisions, only meets four times a year. If the DFG decides against it, more time will pass before the appropriate decisions can be made to establish a target area within the Federal Program on health research. A similar course of events can take place in the case of

47 Such as empirical studies on the epidemiology of diseases, on occupationally related or psychosocial factors, on the efficiency of the health care subsystem (patient-care research) or in the framework of comparative studies of therapy.

International Comparison of Health Funding Systems

special financing of grant proposals via the DFG, which runs into resistance both within the DFG and from the individual states. Thus, expenditures of time are caused by a reservedness on the part of the DFG vis-^-vis certain research topics; in fact, however, it is actually the principle of subsidiarity that leads to the self-restrictive reactions of political funding agencies in the acceptance of certain topics and triggers considerable time costs. The BMFT is the authority chiefly responsible for federal health research funding.^^ In the departments of the BMFT, the different lines of research policy are brought together. Nonetheless, the project-grant agencies {Projekttrdger), which are responsible for the administration of extramural funding, and a series of big science centers (BSC), which carry out independent research in a limited number of health fields, are also of crucial importance. Germany is the only country of the four which has separated intramural and extramural activities into different organizational domains. Big science centers, which are predominantly financed by the BMFT (and in part by the states), are supposed to conduct research in politically selected areas (such as cancer or nuclear research) where a concentration of scientific effort and resources is needed to transfer basic knowledge into application. Though this corresponds to the strategic research of ftinding agencies in other countries, the difference between the BSC and these agencies is the absence of any substantial extramural activities. Extramural funding is instead conducted by organizationally separate, but administratively integrated, project-grant agencies. They are in charge of broad federal research programs for the promotion of, for instance, biotechnology or health. Since 1978 the BMFT has spoonsored a Federal Program on "Research and Development in the Service of Health" which is up for renewal every 4 years. Within this program the federal government carries out its most prominent activities in regard to the development of health research. There are about 6 BSC whose research budget is wholly (i.e., the German Cancer Research Center and the Max-Delbriick-Center) or substantially devoted to health research.

48 In Germany as in the U.S. the activities of the states are very limited when it comes to health research funding. The federal government is clearly the dominant player in extramural funding, though basic-facility funding is either the domain of the states (for universities) or a joint task (for nonuniversity research institutes).

79

80

The Role of Funding Agencies in Health Research

Though the BMFT is responsible for the research and fiinding activities in both sets of organizations, a policy coordinating the activities of BSC and project-grant agencies, the intramural and extramural component in research ftmding of the ministry, is only just emerging. Accordingly, German federal funding of health research can be represented as a triangular constellation of three interlinked points, with the BMFT as the uppermost, connected by an extramural line to the project-grant agencies and an intramural line to the BSC. However, one side of the triangle remains largely open, since the project-grant agencies and the BSC are seldom directly connected, but almost always interact through the intermediary activity of the BMFT. Thus, the decisive point here is that this internal differentiation embeds intramural research and extramural funding in different organizational and planning contexts, something not found in this form in the other three countries. The funding agencies in the other countries receive one lump sum for both tasks from the responsible political authorities, which they are then able to allocate according to their own criteria within their own organization. In contrast, the BMFT provides, on the one hand, monies for directed funding activities in the framework of the Federal Program; independently from this, it also transfers resources for basic-facility funding to the big science centers every year."^^ The difference between BMFT funding and that of the ministries of the other countries is the power of the former to decide on resource allocation between extramural ftmding and intramural research itself. The other ministries have left this up to the public or semi-public funding agencies. Expenditures for the support of health research in the German funding system are distributed as follows: The DFG administered a total of DM 411.6 million in the field of biology and medicine in 1990 (about $240 million). The MPG expended about the same amount of money for its intramural activities in biomedical research. Expenditures for directed ftmding activities in the framework of the Federal Program of the BMFT in the same year were limited to ca. DM 185 million (about $105 million; see Programm 2000, Appendix, Table 1). When the non-basic-facility expenditures on health research of other ministries is included, the amount rises to DM 235 million. In 1990, the whole federal

49 The states also contribute 10% of the basic-facility ftmding.

International Comparison of Health Funding Systems

81

government expended DM 560 million (ibid.: II), or about $350 million on the basic research facilities of health research agencies.

5.2

THE SCOPE OF INFLUENCE OF FUNDING

Given the challenges and problems in health research and the differences in the organization of health research, what can funding agencies do to improve the situation for the better? The problem-solving capabilities of funding agencies are intimately connected to the relationship between sponsors (the administrative staff in funding agencies responsible for the coordination and development of funding strategies) on the one hand, and scientists/clinicians on the other. For this reason, it makes sense to preface our remarks with a review some of the essential properties of research funding relationship: Research funding can be characterized as a voluntary act of exchange between the research sponsor and the grant recipient in which financial support is provided in exchange for the subsequent performance of a defined task on the part of the recipient. One can get a clear view of (short-term) research funding by picturing it as a provision of an advance payment on the base of credibility (or reputation) earned by former performances of the researcher. This allows the researcher as borrower to maintain his or her research activity for a short time and that puts the research sponsor (as granter of the advance payment) in the position to influence the behavior of scientists and clinicians. Though the research sponsor does not receive any interest for making financial resources available, he or she does receive results - here in the form of "practical knowledge" or an "advance in knowledge" - which is in his or her interest. In order to receive "a loan", an investigator has to be worthy of credit and credibility. Since here - unlike on the market, where commodities are directly exchanged for one another - financial resources are exchanged for the promise to provide results, the researcher enjoys an "advance in trust." Such trust is usually gained by the researcher on the basis of the reputation that he or she enjoys in the scientific system and by means of the evaluation of his or her funding proposal by experts. Like every other extension of credit, research sponsorship is an investment that involves risk, since there is a very real possibility that research will not yield the results sought by the sponsor.

82

The Role of Funding Agencies in Health Research

In the promotion of research, the attempt is made by means of (material) incentives (the motivational component of research) to maintain or expand research activities without stipulating research topics {general or incentive mode of funding)', to influence the selection of research themes and activities (program funding) f^ or even to improve the structures of research activity {structural funding).^^ All types of funding can be made use of to improve the present state of clinical research. Whatever kind of funding activity a sponsor chooses, in order to raise the probability of success, it needs recipients - thus in this case researchers who react to financial incentives and are capable of dealing adequately with the topic in question. The supply of money alone cannot guarantee the success of funding agencies. The next question is, therefore, whether we find significant differences in the preparedness of scientists and clinicians in the four countries to make use of the "loans" offered by funding agencies. By answering this question we are able to measure to some extent the scope of influence of health research funding agencies, i.e., the potential number of funding recipients for the funding measures of the particular agency, in a comparative perspective. The scope of influence is an important factor for the strategy-building of funding agencies. Again, it seems that the position of NIH is more favorable in this respect than that of its European counterparts:

50 In program funding, financial resources are made available for research purposes if the scientist is willing to modify the contents of his or her research in accordance with the policy aims and programs of the research sponsor. 51 Financial incentives in structural funding are not only aimed at drawing the recipients' attention to certain research areas (that have possibly not as yet been worked on), but also at ensuring either the long-term possibility of research or the establishment of a research structure that can increase the efficiency of research in these areas. Thus, structurally oriented funding always has a long-term perspective and is targeted at the efficiency of the research system as a whole (Braunling and Harmsen 1975: 56).

International Comparison of Health Funding Systems

Figure 2:

83

Funds expended on biosciences in 1987 per 1000 inhabitants in selected countries (in US dollars)

Funds Expended on the Biosciences per 1000

US-Dollar

Legend ^ ^ Basic-fadlity funding ^ § Grants \~~\ Nonuniversity research

England

FRQ

France

USA

Country

Braun: 5/2 Expenditures were calculated as a percentage of the population of the country, in order to gain a comparative gauge of the level of expenditures. Basic-facility fundingy public financing provided to the universities for their basic material and operational costs, i.e., for their basic facilities; Grants^ all government financing for short- or medium-term funding projects at universities, technical colleges, and institutions working in cooperation with university facilities; Nonuniversity research^ public financing of nonuniversity research and funding facilities. All data are taken from Irvine et. al. 1990: 29-31, 33-35, 38-40, 63-65, 67-69, 93-95, 98-100, 148-151, 155-157.

Figure 2 shows the enormous importance of grant-based funding in the American system. In contrast, in England and Germany, the structure of financing is marked by the basic-facility funding provided to the universities. In France, on the other hand, the importance of the grands organismes makes the basic-facility funding provided to nonuniversity research organizations the most important element of the funding system.

84

The Role of Funding Agencies in Health Research

It is often argued that the basic financial security provided to universities and other research facilities by means of public, basic-facility funding allows researchers to dispense with grants. Accordingly, in ftinding systems with a high level of basic-facility funding, one might expect to find the scope of influence of funding agencies limited. This would then force funding organizations to make especially attractive grant provisions in order to stimulate demand. Though this hypothesis might still have been appropriate for the sixties and seventies, it hardly gives an accurate picture of research at European universities in the eighties and nineties. Though grants only make up one third of the total university financing in England and Germany, it is almost impossible to finance research on the basis of basic-facility funding (see for Germany: Schimank 1993; for France: Braun 1993a, Vol. 2).^^ In both countries, the universities receive a total funding package that they can then allocate according to their own choosing. The greatest share of these resources are expended, though, in a period of financial strain, on general administrative costs, the libraries, and instruction. If research is to be undertaken, it is up to the German, English, and French professors themselves to raise the necessary outside funds. This would relativize what first appeared to be a marked difference between the scope of influence of NIH and that of its European counterparts. Undoubtedly, the importance of basic-facility funding at European universities remains greater than in the United States. Nonetheless, it is primarily directed to instructional purposes, leaving scientists dependent upon grants. Thus, if research is to be performed in Europe, there are good chances that there will be demand for the research "credit" provided by funding organizations. There are, however, two reasons why the scope of influence of NIH is greater than that of other ftinding organizations: First of all, the pressure to do research is different for health researchers in the U.S. and in the European countries. A tenure position in European

52 Schimank (1993) showed that only a small percentage of professors at German universities has not directed a grant-ftinded project in the last three years. Given the financially dubious position of English universities and the fact that French universities are traditionally poorly equipped for research, it is hard to imagine that their situation is very different.

International Comparison of Health Funding Systems

85

universities still gives the clinician or scientist ample opportunity to abstain from doing research if he or she chooses to do so. This is not possible in the research medical schools in the United States because here corporate identity is directly linked to the research performance. The corporate identity of medical schools in the European countries is still largely tied to the three functions of patient-care, education and research. In the United States, there is a strong tendency at all research-oriented medical schools to assume responsibility for only a fraction of the scientists' salaries. Assistant and associate professors are often expected to have their total salaries financed by means of soft money. There are medical schools where the entire academic research staff is financed by research grants. Thus it is not surprising that an estimated 20% of research-university working time is devoted to the writing of grant proposals. Of course, there are transitional arrangements for newly appointed and/or young scientists. For example, the dean at one medical school reported to me that his school pays 100% of a scientist's salary his or her first year, 75% the second year, and about 50% the third year. From the fourth year on, the scientist is expected to earn his or her full salary solely by means of grant proposals. The relationship between the fixed part of a salary paid by a medical school and the soft part obtained from funding resources varies of course according to the time the scientist invests in doing research. The funding agencies only pay for the time the scientist actually devotes to research. If he or she, however, has to teach or take care of patients, the medical school has to assume this part of his or her salary. The more research a scientist does, therefore, the more dependent he or she becomes on soft money. Accordingly, U.S. funding organizations dedicated to promoting biomedical research exert a much greater and more profound influence on individual scientists and their decisions than do their counterparts in the other three countries. Secondly, NIH extends extramural funding not only to individuals or research teams, but also to institutions. For example, medical schools are directly provided with fiinds for promoting training or for other supportive measures in the area of human capital in order to improve the structural effects of existing funding measures. Educational institutions are given the opportunity to acquire funds from an undergraduate training program. Other measures are aimed at prompting universities to give outstanding researchers special support (research career awards) or to fund investigators working in areas deficient in research (institutional research fellowships). In addition,

86

The Role of Funding Agencies in Health Research

NIH employs institutionally directed funding measures to finance university modernization and infrastructure (e.g., research facilities construction grants). What is special about these measures is that the NIH seeks to work with funding programs aimed directly at the authorities responsible for the structures and resource allocation at research institutions. The decentralized allocation of grants is one advantage of such an institutional focus to directed funding activities. The universities themselves decide which students, scientists, or physicians are eligible for the educational measures in question. In many cases, the intimate connection between institution and researcher involved in such a selection results in a higher rate of success. Undoubtedly, the greater visibility of resource allocation and the direct accessibility of the grant-providing authorities provokes more fierce competition among university scientists and institutes. Nonetheless, it also leads research institutions and their actors in administration and science to develop a self-interest in the acquisition of funding resources. As already mentioned, this self-interest is further strengthened by the indirect cost awards for such things as rooms, laboratories, and technical laboratory equipment that is provided in all extramural projects. Whereas German federal funding requires universities to provide an infrastructural contribution of approximately 10% to every funding project, NIH reimburses the expenses of research facilities that accept funding projects. These indirect cost awards accounted for 30% of NIH's total extramural funding expenditures in 1988 (NIH 1989: 53). However, given the scarcity of financial resources, these expenditures now represent a growing funding problem and have become the subject of controversy (see also Braun 1993c). After the Second World War federal agencies not only supported universities by direct and indirect cost reimbursements. In addition, they provided facilitation grants to medical schools. Up to 50% of the costs for constructing, remodeling, and equipping new or existing buildings for the health sciences were provided within the framework of this program (Institute of Medicine 1990: 151). When the facilitation grants program ended in the early seventies, medical schools had no funding sources to compensate for the losses. As a result, they used the funding resources they obtained as compensation for indirect costs, not only to pay the real overhead costs incurred by research projects, but also to meet other costs entailed in the maintenance of a medical school as a whole. In this way the

International Comparison of Health Funding Systems

share of indirect cost payments of NIH rose relative to direct costs,^^ eroding the capacity to supply sufficient means for new grant proposals/'* In 1970 indirect costs added up to $111 million (21 % of total costs). In 1989 they had increased to $1.5 billion (31.6% of total costs). The NIH finds itself, therefore, in an uncomfortable position: its project grant money is the most important source for paying researchers' salaries and for supporting young investigators and innovative research. At the same time the financial needs of medical schools with regard to research facilities force NIH to redistribute its resources in favor of indirect cost reimbursements. Despite these developments, in a comparative perspective, the opportunity provided universities to use grants as a means of basic-university financing creates a continuous and large-scale demand for NIH resources. In this way, the provision of a large share of university resources is dependent upon meeting the performance-based funding criteria of NIH. Thus, the scope of influence of funding instruments is increased in the United States, in contrast to Europe, by the interest of researchers and institutions in grant-based funding. As long as the institutions at which research takes place are not given any incentives to develop their own self-interest in the resources of funding organizations, the effect of the latter on the building of university structures is limited. The directed funding of institutions does not, however, represent an institutional device that can be recommended for all other funding systems. Only where universities possess decentralized decision-making powers and compete with each other for resources, does it make sense to provide institutional incentives for the establishment of certain educational measures or for realizing the structural policy goals of funding organizations. Only in this case are universities willing and able to adjust their courses of

53 Though the average share of indirect costs was only 31.6% in 1989 (NIH 1990: 47), the research medical schools were often reimbursed for 50%-100% of direct costs. 54 The discovery of recent abuses of the indirect cost system has led the Congress to draw up legislation that will cap reimbursements for administrative expenses at about 26% of direct cost payments (Barrinaga 1991; Hamilton 1991; Palca 1991).

87

88

The Role of Funding Agencies in Health Research

instruction to such funding measures or to restructure their resources within and between departments. INSERM and CNRS in France are the only funding agencies which are able to exploit similar advantages in a completely differently designed French system. The enormously weak institutional facilities provided to French universities and the established character of their research teams at universities and hospitals enable the grands organismes in health research to decide according to their own criteria which university researchers are to be given the opportunity to perform research under its auspices. Moreover, the research funds that the Ministry of Education provides the universities with as part of its basic ftinding are themselves contingent upon the amount of resources acquired from the grands organismes. For this reason, in principle, basically all research performed at a French university has in some way been defined by the grant criteria of the grands organismes. This, however, does not provide them with any influence on university structures themselves. Quite the opposite, the research units of CNRS and INSERM often function in relative isolation within university surroundings that remain hostile to research.

5.3

PRELEVDNARY CONCLUSIONS REGARDING INFLUENCE OF FUNDING AGENCIES

THE SCOPE

OF

Funding organizations can be shown to differ in the absolute size of their resources, their position in the ftinding system, and the scope of influence of their funding measures. NIH is equipped with greater resources than its counterparts in the European systems. The enormous sums that NIH administers obscure the fact that it assumes responsibility for an important percentage of basic-facility funding at universities, in addition to its intra- and extramural funding activities. For this reason, the higher overall level of grant resources at NIH's disposal should not be simply taken to represent a greater potential for developing its funding instruments. However, the advantage of NIH is that a decentralized and competitive university system forces scientists and clinicians to apply for grants provided

International Comparison of Health Funding Systems

89

by NIH and that it is able to draw the research institutions themselves into funding competition. In this way NIH has a key role in the selection process governing health research topics. INSERM and CNRS have a similar influence on their own intramural investigators and on many university researchers, but they have much less influence than NIH on the institutional organization of research. Thus the funding organizations in the U.S. and France have a greater scope of influence than their counterparts in England and Germany, even though there are now few differences left between the countries in terms of demand for grant resources. Figure 3 schematically represents the differences in the scope of the formative powers of fiinding organizations.

90

The Role of Funding Agencies in Health Research

Figure 3:

A comparison of the scope of the formative powers of funding oi^anizations Type of funding system

Funding ressources

Sphere of influence

NIH (U.S.)

Monopolistic

Large

Large

Yes

INSERM/ II CNRS(France)

Dualistic

Mediumsized

Medium to large

Yes

MRC (England)

Dualistic

Mediumsized

Mediumsized

Yes

DFG (Germany)

Fragmented

Mediumsized

Mediumsized

No

BMFT (Germany)

Fragmented

Mediumsized

Mediumsized

No

5.4

Integrated intramural research

THE ROLE OF POLITICS AND SCIENCE IN FUNDING POLICY AND FUNDING PROCEDURES

Strategic alternatives of funding agencies in dealing with challenges in health research are certainly set by their financial room for maneuver and the degree of dependence of scientists and clinicians on project grants. In addition they are influenced by external actors. As intermediary agencies between the political subsystem on the one hand and the scientific subsystem on the other hand, funding agencies are constantly subject to attempts by policymakers and scientists to shape funding policies according to their own needs (see also Braun 1993e). The outcome of this interest struggle is dependent on the degree of autonomy of funding agencies and the way the relationship with both the political and the scientific subsystem is structured. Funding agencies that are not financed by private means cannot evade contact with, and the influence of, political decision-makers: for the latter are

International Comparison of Health Funding Systems

91

the "creditors" of financial resources delegated to funding agencies given the task of distributing them to the scientific community. Neither can funding agencies insulate themselves from the scientific community, since scientists and clinicians are needed for conducting the research that funding agencies are interested in. The (political) creditors often expect funding agencies to demonstrate short- or middle-range success in stipulated research areas that will legitimate the implementation of the funding program, whereas science expects funding agencies to make long-term investments in a large variety of research fields. It is this precarious position between often conflicting interests which is of interest to us in this chapter. I will, therefore, turn to a description of the way the relationship of funding agencies with both political and scientific actors is structured. Differences in the structuring of the relationships will account for various degrees of autonomy of funding agencies and, hence, for differing degrees of maneuvering room in dealing with challenges in health research. Most semi-public and public funding agencies in health research were set up by political decision-makers. I will call these funding agencies mission agencies. Most of the funding agencies mentioned so far in the context of health research belong to this group. Another set of funding agencies came into existence primarily through the promotional efforts of scientific actors. These funding agencies are all-around agencies (OECD 1972: 72). Since they are not specialized in funding one particular area of research but are dedicated to the overall promotion of research by means of project grants. Examples of funding agencies in this group are the DFG in Germany, the NSF in the United States, and the CNRS in France.^^ The agencies in this group are as dependent on the supply of funding resources by political decision-makers as are mission agencies. A final set of funding agencies was set up by private actors in the form of foundations.

55 The CNRS is peculiar in this respect. It had a clearly defined task to realize political research aims but has been able to lead a quite independent life guided primarily by scientific strategies (see Picard 1990; Krauss 1993).

92

The Role of Funding Agencies in Health Research

5.4.1 Forms of Coordination Between Funding Organizations and Political Creditors The relationship of political creditors and (semi-)public^^ ftinding agencies is structured by the degree of political influence exerted in funding agency decisions. Political influence indicates the extent to which political authorities, in formal terms, are able to direct funding organizations according to their own wishes. The following indicators can be viewed as gauges of the degree of political influence: • Are political authorities able to issue directives to the funding organization? • Is the budget of theftindingorganization directly affected by the annual budgetary policy-making process of the government? • Do political representatives take part in decisions on administrative and financial matters? • Do political authorities make the appointment decisions for executive positions in the funding organization? • Do political authorities have an important say in the formulation of general funding policies? • Do political authorities participate in the routine course of procedures for making funding decisions? If one attempts to make a tentative assessment of the degree of political influence by taking these indicators into account, the following summary results:

56 The expression "semi-public" denotes the special legal position of funding agencies which as agencies are not subject to the direct authority of a governmental ministry, but still have public commitments to fulfill. In exchange for this conmiitment they are normally entitled to tax exemptions. Public agencies, in contrast, are funding agencies directly incorporated within a government ministry. The precise legal definitions and the legal status of semi-public agencies differ from country to country.

93

International Comparison of Health Funding Systems

Table 4: Degree of political influence in funding agencies

Funding Agencies Indicators of Political Influence

MRC

INSERM/

NIH

BSC

Projectgrant agencies

DFG

cms

II Directives

No

No

Yes

No

Yes

No

1 Bt4dget1 Process

Yes

Yes

Yes

' Yes

Yes

No

Participa1 tion in 1 adm. 1 matters

No, but control afterwards

No, but control afterwards

Yes

No, but control afterwards

Yes

No

Appoint1 ments

Secretary and several representatives in scientific bodies

Director and several representatives in scientific bodies

Director

Director

Yes

No

1 Policy-For1 mulation

Yes

Yes

Congress to some extent

No

Yes

No

No

No

No

Yes

Yes

1 Funding 1 Decisions

i No

1

I will not go into the details of this table, since the differences in the relationship will be discussed more extensively below. The two endpoints of the continuum of political influence can be described in the following way: The extreme case of complete political influence (i.e., control) exists if the political authorities are able to issue directives to the funding organization and are legally the responsible signees in funding decisions. In this case, legal steps can only be taken against the responsible ministry and not against the funding organization. The project-grant agencies of the BMFT in Germany seem to be a case in point. The extreme case of complete political independence exists if political authorities have no direct means of sanction to use to influence the funding organization and also in no way participate

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The Role of Funding Agencies in Health Research

in funding organization decisions. The DFG seems to come nearest to this extreme. The other funding agencies in question find themselves somewhere in between these two extremes. How does a different degree of dependence on political decisions affect the policies of funding agencies? T\\Q project-grant agencies of the BMFT in Germany are more strongly linked to political authorities than most of the other funding organizations investigated. Project-grant agencies initially arose due to a work overload experienced by BMFT departments. They now have more staff members than the BMFT itself. Project-grant agencies are administrative units, which, though they act independently in organizational terms, do not have any separate decision-making authority. The Ministry is responsible for the development and implementation of the Federal Program on Health Research. Project-grant agencies are institutions, primarily at big science centers, which ease the burden on the BMFT by taking over scientific-technical and administrative management tasks, such as the planning, assessment, regulation, and the monitoring of the procedural course and success of funding measures in the framework of a funding program or a part thereof. Their activity is restricted by the guidelines and directives of the BMFT, which makes the funding decision in each individual case. The project-grant agency works as commissioned by the BMFT. (BMFT 1987: 22)

The Federal Program on Health Research is administered by three such project-grant agencies. Two agencies deal with all kinds of activities, as stipulated in the program design. One agency was specifically established to set up AIDS research in Germany and will be dissolved once it concludes this task. As a rule, project-grant agencies cannot actually make any funding decisions on their own; they are only supposed to lay the basis for such decisions^^ and support the appropriate BMFT department in the introduction of new target areas (priority areas) of research. Such target areas may even originate from the project-grant agency itself. And this is in fact frequently the case, since its sponsors enjoy direct contact with the

57 "The tasks of the project-grant agencies do not include...the funding decision, i.e., especially the determination whether a grant should be made and to whom, for which project and to what extent the grant should be made, and which secondary provisions are to be applied" (BMFT 1987: 22).

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researchers and are thus able to translate information from the scientific community into political categories of need. Indeed, the project-grant agency serves regularly as the intermediary: it has to translate the objectives of health policy into scientific language in its call for grant proposals and has to transform the subsequent scientific responses back into policy terms. Additionally, it has to ensure that the actual grant process runs its course without a hitch. It thus has to offer the applicant advisory support, spell out the obstacles and opportunities involved in government ftinding, and choose the appropriate reviewers for the grant application. The peer-review meetings have to be organized and the results of these meetings have to be sent on to the appropriate department at the BMFT so that any grant awards can be announced. Since the problem frequently arises that there are no appropriate grant proposals in certain deficient fields of research, the project-grant agency must also actively endeavor to find applicants and then provide them with the necessary infrastructural research facilities. Project-grant agency support the BMFT, therefore, in program formulation, in the implementation of the grant process, and in the active public promotion of the objectives of the program. Sustaining funding activity - and thus reproducing the credibility cycle and the viability of the organization - is ultimately tied to the extension of the Federal Program the project-grant agencies administer. The Program is reevaluated every four years on the basis of the program achievements made up to that point and the problems still demanding resolution. Since the staff members of the project-grant agencies are not permanently appointed - unlike the civil servants on BMFT department staff - and thus may loose their positions if the program is disbanded, they have to develop a self-interest in the (extention of) operations of the funding program. This self-interest is strengthened by the fact that research funding is bound by the principle of annuality. Though the intention of this principle is one of administrative rationality (making action calculable), its consequence is a regular evaluation of performance, since on the basis of the annually allocated funds, cuts to, or extensions of. Federal Program funds are made. The project-grant agencies have to at least reach the target set in their middle-range financial planning, if they do not want to run the danger of having their Federal Program funds curtailed. In addition, a competitive principle is built into the structure of funding, since there are two project-grant agencies receiving their annual budgets

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The Role of Funding Agencies in Health Research

from the Ministry.^^ If one of the project-grant agencies commits its fiinds more quickly and exhaustively, the other one has to transfer part of its funds to it. It can be deduced from this combination of compulsory requirements (the periodic review of the Federal Program, the principle of annuality, funding competition) that the project-grant agencies have to have a great interest in successful research funding. This can have the positive effect that the staff carries out its fimding activities with great commitment and thus makes an essential contribution to the success of the program. On the other hand, however, the danger exists that the self-interest of the research sponsors in the perpetuation of their own work expresses itself in a dynamic of seeking more independence from government interference and expanding the existing domains of competence in funding to increase the scope of their influence. Only the National Institutes of Health in the United States seems to exhibit comparable features in its coordination with political authorities. NIH is, as is described above, a government agency of the Department of Health and Human Services (DHHS) and thus, in a formal sense, subject to government directives. Administrative decisions involving personnel and organizational changes in particular are contingent upon the consent of authorities superordinate to it in the administrative hierarchy. Nevertheless, in many ways, NIH has a different position in the system of political administration from that of the project-grant agencies of the BMFT in Germany. It has long had its own organizational identity within the DHHS, which has ensured it a high degree of autonomy in questions of science funding and research in the area of health. The strongly fragmented character of the political-administrative system of the United States only serves to heighten this autonomy. Precisely in the field of research policy, no separate coordinating authority exists. This provides the individual agencies that administer the subsections of such a research policy with considerable decision-making latitude in shaping their own funding policies (see also Lehner 1985). Accordingly, research funding can in no way be seen as the product of ministerial research policy, such as it exists in Germany. It is the legislative rather than the executive branch of government that plays an important role in the United States. The process of adopting a

58 The funds for the AIDS agency is allocated by one of the other two project-grant agencies.

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budget in the United States is structured in such a way that it allows NIH, via the Congress, to escape the budgetary constraints placed on it by the (executive branch of) government. By negotiating with the budgetary committees of Congress, it is able to acquire considerably more funds than were approved by the executive branch. In this way, the Congress becomes a direct arena of negotiations in which NIH can enter into processes of exchange with its members. At least in financial terms, this opportunity structure allowed NIH, for a long time, to free itself to a certain degree from the political influence of the executive branch of government. Naturally an exchange relationship requires from NIH that it be open to the wishes and plans of members of Congress, and thus to those of their constituents, the general public. In this way, funding topics frequently find their way into NIH via the congressional negotiating arena and are then referred from there to the scientific system. The stronger the position taken by Congress in these negotiations - and this is a function of the financial situation of the American government at a given point in time - the greater the danger of the fragmentation of NIH funding policies. For Congress itself is not a coherent body; it consists rather of an array of individual "political entrepreneurs," each of whom brings special interests into the negotiation process. Thus, this procedure means that a coordinated research and funding policy is only rarely formulated in the United States (for example, in the concerted national fight against cancer in the seventies). NIH itself is the only guarantee for the coherence of its funding policy. By comparison, in Germany, the BMFT is responsible for the coordination and planning of research policy. The parliament or individual politicians occasionally still exert some influence on ministerial policy in their pursuit of public-interest oriented objectives, but this occurs less frequently than it does in the United States. In spite of the direct dependency of NIH on government finances and political-administrative directives, the degree of political influence is certainly less than in the case of German project funding agencies. NIH may be regarded the trustee of the people and government in matters concerning health research funding. Project-grant agencies are more comparable to the delegate directly responsible to a political authority (Braun 1993e). The difference between the German and American systems consists in the fact that the hierarchical relationship between the BMFT and the project-grant agencies grants the latter fewer opportunities to react flexibly

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The Role of Funding Agencies in Health Research

and on a decentralized level than NIH is afforded by the negotiatory networks found in the United States. In Germany, funding policy is ultimately a ministerial matter and not that of the funding authorities that implement it; in the United States, it largely becomes the task of the government funding organizations. The responsible ministry retains policy-making power in the Germany, even though information is gathered and processed on a decentralized level. Consequently, such a relationship can lead to a discrepancy between a logic addressing administrative objectives and one oriented to the substantive problems at hand (see more extensively Braun 1993a, Vol. 1);. The very opposite proves to be the case in the United States. In the congressional negotiating arena, so-called iron triangles have formed in which substantively oriented decisions have been able to prevail over an administrative-financial logic (Strickland 1972; Heclo 1978). All participants in this triangle (interest groups, members of Congress, and NIH) had a self-interest in the success of health research and did not want this success to be limited by considerations of budgetary policy. Above all, however, they possessed the resources and positions of power within the political system needed to realize these interests. This special constellation gave NIH flexibility in its actions, and ultimately, accounts for its successes in the funding of health research. This favorable position has dramatically declined since the end of the 1980s (Braun 1993c). Still, in 1981, NIH was able to conclude a deal with Congress in order to maintain its funding levels despite financial cutbacks. It was agreed that a specified minimum number of new and competing projects grants should be appropriated by Congress and awarded by NIH. This measure was supposed to prevent the erosion of the "investigator-initiated grant" (Institute of Medicine 1990;see below for details). The agreement provided NIH with some relief in that it addressed the rising number of applications witnessed during the 1980s. The situation has deteriorated considerably, however, since 1989 when the Congress abrogated the deal. Since then, the Congress has become more and more reluctant to provide NIH with the usual surplus in funding resources. In 1992, for the first time in history, the Congress appropriated a lower budget for NIH than even the President had asked for (The Chronicle of Higher Education, December 2, 1992: A28). The "earmarking" of appropriations to NIH has become a preferred strategy of the Congress. In the most recent budget only those institutes at NIH prospered which could demonstrate that

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they were actively engaged in disease-related areas of congressional concern, such as AIDS research and women's health research (Chronicle of Higher Education, December 2, 1992: A28). In contrast, basic research without a clear applicational orientation, as it is conducted by the National Institute of General Medical Sciences, is hard-pressed to avoid funding cuts. If we move down the scale of political influence on funding agencies, we find the British MRC, the French INSERM, and the German big science centers (BSC). The BSC were established as private limited liability companies, foundations, or registered associations. The aim was to allow companies from the private sector to participate and to give the BSC greater legal flexibility in terms of budget and personnel (Hohn and Schimank 1990: 247). INSERM and CNRS are two of the €tablissements publiques scientiflques et technologiques (EPST) that were newly created in 1982 and expressly freed from the hierarchical control of the ministries. They also received a more flexible administrative status and a general budget, which they administer themselves (see more extensively Braun 1993a, Vol. 2). The MRC has the status of a corporate body. This gives it legal responsibility for its own actions, enables it to enter into agreement without government consent, and administer and use its grants at its own discretion. It has the authority to appoint its own scientists and other personnel and to fund them according to its own judgment. These agencies are, as NIH and the project-grant agencies, dependent on the distributive struggle in the appropriation process of the government budget. On the other hand, they enjoy a great measure of independence in the administration of their financial resources and in their internal policy-making. What Hohn and Schimank (1990: 247) say about the relationship between political authorities and BSC in Germany also applies to INSERM, CNRS, and MRC, and to a certain extent, to NIH: political actors are not interested "in being able to control research work in detail with specific instructions..." They want instead to limit themselves "to interventions that guide organizations in the general establishment of their missions and structures and the choice of executive personnel." The term ''general guidance" applies not only to the political influence of the BMFT

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The Role of Funding Agencies in Health Research

on the BSC, but also to that of political authorities in France^^ and England on their respective funding organizations. Political authorities are represented in all three organizations on the basis of this more modest approach to political control, though in different institutional forms: The representatives of the responsible ministries^ have seats in all of the highest administrative or decision-making committees (in the BSC on the board of trustees, in INSERM in the conseil administrative, in CNRS in the conseil d administration, and in the MRC in the Council). They do not have majority voices and certainly no authority to issue directives. However, even in a minority position, their position as chief fiinder provides them with considerable veto powers. Such powers are almost exclusively restricted to use in the context of the annual budgetary demands of funding organizations and do not extend to these organizations' concrete and substantive plans. The administrative or decision-making committees of the funding organizations in this group can be seen as forums for negotiation in which a largely cooperative game takes place between its participants, since they all have a stake in the continued existence and efficiency of the organization. The aims of the representatives of the ministries in this context are to legitimate the funding of such an organization in the eyes of the public and the finance ministry and to defend it against competing claims for resources from within the political system. Today they rarely attempt to effect direct political control of funding policy.^^

59 In case of the CNRS Picard speaks of a "pilotage sans visibility," i.e., the almost unvisible guidance of policymakers vis-a-vis the CNRS (1990: 267). 60 The responsible ministries in each country: In France, they are the Ministry of Education for the CNRS and the Ministry of Education and the Ministry of Health for the INSERM. In England until 1993 the Department of Education and Science distributed the funds for Research Councils, but the Department of Health was also incorporated into several decision-making processes. In Germany, the BMFT and the Ministry of Education of the individual state in which the BSC is located take part in decision-making procedures. 61 This was not always the case: as late as the 1970s, the INSERM and the German BSC had to accept greater intervention on the part of political authorities (see more extensively Braun 1993a, Vol.1 and 2; on the BSC, see Hohn and Schimank 1990). However, with the introduction of the policy of "general

International Comparison of Health Funding Systems

Aside from the influence that political representatives can exert in committees, the ministries of the three countries (and also the president of the United States)^^ are also able to make executive-position appointments to the funding organizations, often though, upon the recommendation of scientists. In France, it is quite common to replace the directors of a mission agency if, in the opinion of the ministry, they have not been efficient, a change in government has taken place, if they have not sufficiently taken the interests of political authorities into account. The secretaries at the MRC possess, in spite of the education minister's formal right to have them recalled from office, a relatively stable position. English political authorities have as yet made little use of this right to recall. A similar state of affairs has existed at the German BSC since the eighties. Moreover, the appointment of the director of the funding organizations does not necessarily extend the scope of influence of political authorities. Lazar, the current director of INSERM, has made this abundantly clear (Lazar 1989). First of all, directors are scientists and thus do not necessarily have to devote themselves to any particular political goals. Secondly, during his or her period in office, political authorities are not in any way able to exert pressure on the conduct of the director. It can be observed that directors develop their own independent approaches, which are primarily marked by concerns for the preservation of the organization and the efficiency of ftinding and research and only secondarily by external (nonorganizational) considerations or considerations of a political character. In spite of the different forms of political interdependence found on this level of political influence, theftindingorganizations have managed to attain

guidance" in the German BSC and INSERM's attainment of EPST status in France in the eighties, direct interventionary approaches have clearly been rejected (on France, see Braun 1993a, Vol. 2). In contrast, there have been major attempts of political reform concerning the CNRS in order to increase political influence on ftinding strategies. This is for the major part caused by mismanagement and the inclination of the scientific disciplines represented within the CNRS to isolate themselves from any problems formulated by political representatives (see also Krauss 1993). 62 In the United States, the president is entitled to appoint the director of NIH according to his own discretion.

101

102

The Role of Funding Agencies in Health Research

or preserve a relatively autonomous position in the management of their organizations. Lazar characterized the relationship between INSERM and political authorities, which I consider representative for all funding organizations in this field, as one of dynamic equilibrium (ibid.). Negotiations on the divergent interests of political authorities and funding organizations cannot be avoided. Each and every actor can jeopardize an existing equilibrium by engaging in unilateral action, but every actor also possesses instruments of power with which equilibrium can be restored. In any case, the maintenance of a dynamic equilibrium is related in most cases to administrative, financial, and organizational questions and less frequently to questions of a substantive nature, which would touch upon the autonomy of science in shaping funding organizations. In this case, scientific aims enjoy a clear priority over political ones, both in the German BSC and the mission agencies in France and England. In spite of this, the funding organizations provide the political system with access to the scientific system that would otherwise be difficult to obtain. Moreover, this access has a structural character, since their financial dependency makes it impossible for the funding organizations to simply cut their ties to political authorities. Thus, the dynamic equilibrium of forces in these funding organizations leads to a constant exchange of political requests and scientific information. This exchange also results in a compromise between all involved parties, where political authorities can make no recourse to the resource of "directives." The substantive and procedural contents of these compromises are ultimately a matter for the funding organizations to decide upon. It is their own operational regulations that play a major role here. If we compare the situation of funding organizations which have an "arm's length relationship" with the political system with those that are more hierarchically coordinated with political authorities,^^ it becomes clear that

63 I am quite aware that I have only discussed the project-grant agencies as genuine examples of funding agencies with hierarchical relationships with political authorities. One should, therefore, be hesitant to make generalizations. Nevertheless, the features isolated here are in line with knowledge derived from the sociology of hierarchical organizations. In addition, there are more than enough funding sections within ministries that very closely resemble this type of funding agency. The talks I have had with the administrative staff responsible for funding measures within several health ministries largely confirm the findings

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the former possess their own negotiating positions as corporate actors, which allows them to advocate their own long-term goals, even in the face of political opposition. Political "disturbances" can occur, but they are treated as external signals and assimilated according to the organizations' own rules. This contrasts with hierarchically coordinated funding organizations: they sometimes have to restructure their procedures in response to such signals. Moreover, this restructuring does not then proceed in accordance with the operational regulations of the organization and independently of political administration; it follows instead the rules of administrative logic. Finally, the German DFG seems to be the funding agency with subject to the least political influence. The DFG is a private, non-profit-making foundation and is largelyfinancedby federal and state governments. This is the source of its financial dependency on public funds. The distribution of government funds to the DFG (and the MPG respectively) takes place within a particular joint government body of federal and state actors, the Federal'State-Commission for Educational Planning and Research Funding (Bund-Lander Kommission zur Bildungsplanung und Forschungsforderung; ELK). Though budget policies influence the allocation decisions, they are somewhat decoupled from the ordinary distributive struggle in government. In addition, the government may make commitments of several years in its DFG financing plans. In contrast to all previously discussed funding organizations, the DFG was not founded by political authorities, but rather through the union of universities and other scientific organizations in Germany.^ Even if the political authorities have become the main source of funding for the DFG, they clearly have less political influence here than in the funding agencies. Political actors are represented on the board of trustees

presented here. 64 In contrast, the MRC was formed by the government at the start of the century in order to fight tuberculosis; INSERM was the successor organization to the French government's department of hygiene; most of the different institutes in NIH were established in response to pressure from the general public and from the political system, and its statutes were laid down by Congress; and the BSC arose at the request of the federal govemment of the FRO, private industry, and scientists.

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The Role of Funding Agencies in Health Research

and in the main committee of the DFG. The vote of science, however, is decisive in these committees (Neidhart 1988: 83),^^ even if political representatives take part in the final decisions on grant proposals reached in the main committee. It is relatively rare for proposals that have been previously approved by peer reviewers to then be rejected here (ibid. 1988: 81). And the evaluative criteria applied by this committee are largely financial rather than substantive in character.^ Indeed, Neidhart denies that this committee has any authority on substantive issues at all (ibid. 1988: 82-83). Nonetheless, the DFG explicitly included the function of political counseling in its statutes. And this self-obligation provides the political system with direct access to the scientific system. However, the DFG also formulates in which areas senate committees may be formed which can receive political counsel. The participation of political authorities in the provision of grant money distributed within the funding measure of special research fields and the occasional cooperation in funding between the DFG and the BMFT also show that the DFG, like the other organizations in this field of coordination, plays an integrative role between the scientific and political realms. 5.4.2 The Role of Science Within Funding Organizations Without the trust of science, no funding organization would be able to carry out its activity as an agency for the promotion of science. The confidence that science has in the working methods and positive effects of research funding facilitates the provision of research credibility and informational access to the scientific system. Without this resource, the formative powers of funding agencies would be considerably curtailed.

65 "The DFG has managed to institutionalize mechanisms of scientific self-government to a remarkable extent" (Neidhart 1988: 83). 66 "The main committee fulfilled its task: it had to keep the DFG from going into debt..." (Neidhart 1988: 82)

International Comparison of Health Funding Systems

Whether science places its trust in a funding organization and thus guarantees that its grant resources are made use of is dependent upon the way in which funding policy and funding procedures satisfy the standards and interests of science. The incorporation of scientific representatives in decision-making and review procedures provides crucial support for the building of trust. It can be shown that science plays an active part in the internal workings of all funding organizations discussed here. Differences do exist, however, in the way this participation is institutionalized and in the importance of scientific opinion in the decision-making procedures of these organizations. What do these differences consist of, when compared internationally? I will concentrate the following discussion on the most important (extramural) funding agencies for healtfi research in each country, i.e., NIH in the United States, INSERM in France, the MRC in England, and the project-grant agencies of the BMFT and the DFG in Germany. 5.4.2.1 The Negotiation Process in the Formulation of Funding Policy. Every funding organization pursues general funding objectives, which are sometimes fixed by the founding statutes (as is the case for NIH, MRC, INSERM, and DFG) and sometimes subject to regular reconsideration (4-year cycles are customary), when they are adjusted to the current developments and problems of science and society. Such general funding objectives establish the relative importance of axiomatic (i.e., purely scientifically oriented) reference points of funding and of social and economic ones. Goals are formulated in reference to recognized areas of scientific study and in terms of the objectives deserving of future research. All actors in the funding organization, i.e., political and public representatives, scientists and sponsors,^^ have a direct interest in decisions

67 The full-time staff in funding organizations can be roughly divided into two categories: The administrative specialists and secretarial staff ar& responsible for administrative and financial problems. On the other hand, the sponsors (who in almost all funding organizations consist primarily of former scientists) are responsible for substantive and progranmiatic coordination. They are the ones with the best insight into the organization's instruments and funding procedures. Accordingly, their main task is the administration of resources for the purpose of attaining the objectives formulated by science and politics. However, they also

105

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The Role of Funding Agencies in Health Research

involving these general goals, since the foundations for future funding activity is laid in this way. On this level, political authorities can give general expression to their hopes and conceptions, without requiring specialized knowledge to do so. For sponsors, global goals establish the framework within which future activities will take place and consequently help determine the chances of success that funding will have. Through his or her input into policy formulation, the representative of science seeks to target research fields of scientific interest. Scientific participation in the formulation of general funding policy objectives varies, as international comparison shows. Thus, within the DFG, science assumes a position that allows it to define scientific guidelines solely in terms of the criterion of "contribution to scientific knowledge." This claim on the part of science to exclusive defining power has been accepted by the political parties involved (see also Neidhart 1988: 132). Whereas science can be interpreted as representing the almost exclusive defining power in the DFG, it has only a dominant influence in NIH and MRC. It is institutionalized in totally different ways, however, in these two mission agencies. The individual institutes of NIH are under the directorship of scientists (the head of the institute and his or her scientific directors). Political representatives play no role within the institutes. Nonetheless, science is not the sole establisher of general objectives: First of all, every institute is bound by its founding statutes, which were approved and in part formulated by Congress, committing it to a certain mission orientation. Secondly, the annual appropriation procedure of Congress enables it, as has been described above, to introduce its own objectives, which however, are frequently of a very specific character. Finally, the National Advisory Boards, consisting of public representatives and scientists, also play an important role by providing counsel to every institute in the selection of research projects and the formulation of goals. Political representatives have no voice on these Boards. Scientists hold the majority of seats. In the MRC, it is the Council that bears final decision-making authority in the administration and allocation of grants and in matters of finance and funding policy. Decisions are prepared by scientific representatives on the various Boards, by the Strategic Committee, and by the administrative staff.

contribute in the development of these goals.

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Political representatives take part in this process as committee members. The scientists have a two-thirds majority on the Council. However, there are a series of government representatives who have a voice in proceedings. Thus, in the United States and in England, scientists have secured for themselves the majority voice in goal formulation. However, the U.S. Congress retains significant collaboratory opportunities, and in both England and France the participation of political representatives on the various committees of the MRC and INSERM, also enable them to defend their interests. The extent to which they are able to influence policy formulation ultimately depends on their negotiating skills and their resources of power (such as the financial dependence of the funding organizations). INSERM and MRC possess very similar organizational structures for decision making. At INSERM, it is once again the scientists (Commissions Scientiflques Specialisees, CSS; and the Conseil Scientiflque, CSf^ who primarily take note of scientific developments and recommend general measures in response to them. They are joined, however, by the director, who, though a proven scientist, is appointed by the political authorities. Possessing a separate scientific advisory staff (College de Direction Scientijique; Codis), he or she is able to pursue very specific social-policy goals (see more extensively Braun 1993a, Vol. 2). It is precisely by way of this group of actors that more application-oriented objectives are incorporated into policy formulation at INSERM. The conseil administrative, the administrative board, also plays an important role, however: it not only prepares the budget, it also approves the general funding goals of the organization. In formal terms, scientists are in the minority on this committee.^^ However, since the crucial preliminary policy formulations are furnished by scientists from the CSS and CS, it is still fair to talk of a

68 These scientific commissions are made up of 25 scientific and technical administrative representatives of INSERM, ten of whom are named by the ministry, but only after being recommended by INSERM. 69 There are four outside scientists and six representatives of INSERM, who are recruited according to their position within the organization. Thus, this also includes technical-assistance personnel. On the other hand, there are also eight government representatives and eight outside representatives from different areas of public life.

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The Role of Funding Agencies in Health Research

relative balance in the respective defining powers of the different sides. Nevertheless, in formal terms, the scientific side is clearly weaker than in the DFG, NIH, or MRC. The scientific representatives involved in the Federal Program of the BMFT, however, find themselves in an even weaker position, in keeping with the hierarchical mode of coordination found here. Decision-making relationships are clearly structured: the ministry makes final decisions on the use of its budgetary resources and on general goal orientation in funding. This in no way implies, of course, that scientific claims are left unconsidered. Scientists have always been made use of in the regular extension of the Federal Program. In addition, scientific influence has been increased in the last two years by the establishment of the Health Research Council.'^ This council advises the BMFT and the project-grant agencies on questions related to BMFT health-research ftinding. Recommendations on the program strategy of the Federal Program (future goal orientation, design, effectiveness of instruments) play a large role here. It is up to the BMFT, however, to what extent it is able and willing to put these recommendations into practice. In contrast to the MRC and INSERM, there was no middle-level program formulation from the scientific side until recently. This left the Healtii Research Council dependent on the presentations drafted by the ministry and its project-grant agencies. This has now been modified to the extent that a Scientific Committee (Wissenschaftlicher AusschuB) has been formed; it has the task of providing the Council with the informational basis for making decisions on important questions as well as with recommendations on these issues. In sum: In the international comparison of the participation of science in the formulation of general ftinding objectives, it is seen that no funding organization leaves science without at least a role in decisions involving the formulation of funding policy. Conversely, political authorities also have at least some say in all organizations. Dynamic equilibrium is reaffirmed as a rule in the process of strategy building in mission agencies, even if this occurs in different institutional

70 The ca. 20 members of this Board (the Gesundheitsforschungsrat) are appointed by the BMFT upon the reconunmendations of scientific organizations and representatives from the individual states.

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forms. Science is the authority which prepares drafts on the informational basis of decisions, but public and/or political representatives retain an important role in decision-making. A change has taken place in the way funding-policy decision-making is institutionalized within the hierarchical coordination of the BMFT. For a long time, there was only indirect scientific input in the preparatory phase of funding policy, by means of outside and unsystematically incorporated reviewers. Now, however, a procedure has been established in which science, as well as other outside actors, are systematically involved in laying the foundations for the Federal Program. In this way, even here, a dynamic equilibrium could emerge over the long term.

5.4.2.2 The Predominant Position of Science in the Awarding of Grants. The selection of grant proposals is especially important for science. By participating in the formulation of the general objectives of funding, it is able to direct the influence exerted by funding on the scientific system into desirable channels. Science has a direct interest in participating in the selection of grant proposals, since by doing so (a) it is able to recognize outstanding scientists and provide them with the support due to them, and (b) it is able - by means of targeted selection-to pass on transformative impulses, which would otherwise be difficult to initiate directly through scientific organizations. Both of these functions can be seen as facilitating the self-organization of the scientific system. The access to the selection procedures of theftindingorganizations allows the scientific system to promote scientific research according to its own criteria, norms, and interests. This secures a firm position for the interests and conceptions of science within funding organizations. An international comparison of the peer review processes, i.e., the procedures on the basis of which grant proposals are selected or rejected, shows science to be in a predominant position, defining the situation almost entirely on its own. Sponsors are the only other participants in the selection process, and almost without exception they play only an administrative and secondary role. This predominant position of science applies, though, only to the first stage of the peer review process, that is to the direct choice of grant

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The Role of Funding Agencies in Health Research

proposals in the review commissions/^ The only selection criteria that apply in the first stage are scientific quality and technical feasibility. In periods of scarce resources, though, they may also be joined by financial considerations. However, in German federal funding, the political selection criteria of the Federal Program are explicitly incorporated into the review process by the sponsors and ministry representatives taking part in it. This does not occur in the other funding organizations until the second stage of the process. Such a second stage does exist in all funding organizations. It always includes more than just scientific actors and sponsors. Government or other public representatives also participate. The authorities represented in the second stage have two tasks: first, to check whether the preliminary selection of grant projects made by science in the first stage is basically compatible with the general mission of the funding organization or with an established area of research within it, and secondly, to see that the financial limits of the organization are respected in this context, as well as the ethical, social, and economic repercussions of the funding projects. There is also a second stage in the German Federal Program, but no scientific representatives take part in it. The BMFT decides alone which grant projects will ultimately be funded and which will not. At the other funding organizations, the following actors and committees are part of the second stage: at the DFG, its main committee (which includes government representatives and representatives of the foundations); at NIH, the representatives of the individual institutes of NIH and the National Advisory Boards (and thus public representatives); at INSERM, the CS is responsible for the second stage (see above); and finally at MRC, the Boards make the final selection of grant projects. Thus, the importance of nonscientific actors in the second-stage selection process varies: their position is at its strongest in the German Federal Program, where no other groups are represented. Their position is weakest in the MRC and INSERM, where political influence is limited to the appointment of members. However, in the MRC, government representatives are able to take positions. In the DFG and NIH, political and other actors take part in decision-making.

71 These are, for example, the peer reviewers in the DFG, the CSS in INSERM, the study sections in NIH, and the project-grant committees in the MRC.

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Problems arise if a grant proposal is rejected in the second stage of the process, even though it received scientific approval in the first stage, or if it is accepted, even though its scientific quality was not recognized. In principle, the authorities involved in the second stage could change the ranking of the projects selected by science on the basis of social, organizational, ethical, or political considerations and thus reject projects accepted by science or approve rejected ones. However, according to the statements of experts, such cases tend to play a subordinate role in the funding organizations investigated here. It can thus be established that science is strongly represented in the process of selecting grant projects in all funding organizations. With the exception of the German Federal Program, scientific quality is able to establish itself as the exclusive selection norm in the first stage of the process. It cannot do this, however, at the expense of the funding organization qua corporate actor. This is ensured by the second stage of the process. The funding principles laid down in the statutes, financial restrictions, and the avoidance of external repercussions are all taken into account in the second stage of the process by means of negotiation. The way in which science takes part in the second stage varies. It is only in the hierarchically coordinated Federal Program in Germany that grant proposals are approved without the input of science in the second stage. In NIH and DFG, nonscientific actors have a right to a say, even though the relative weight of science is greater. At INSERM and MRC, the institutions that makefinaldecisions on grant proposals have purely scientific staffs. The political authorities are only indirectly represented on these committees, through their appointment of a share of the representatives. In summary: Differences exist in the scope of participation of science in the various funding organizations. Science plays a leading role in the formulation of funding policy and in the selection of grant proposals in the research councils and the DFG. This results in a continuous and satisfactory level of trust in the funding organizations on the part of science. By comparison, science is somewhat less strongly represented in the German Federal Program, at least in terms of the grant-proposal selection process. However, in terms of general program formulation, adjustments have now been made in keeping with the general trend, and science has been given a prominent voice in the planning phase of the Federal Program. Nevertheless, the BMFT continues to make exclusive and authoritative decisions on

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The Role of Funding Agencies in Health Research

program formation and ftmding approval. Occasionally, this can lead to scientific reservations being overruled by political considerations. The influential position of government or other nonscientific representatives can also be found at NIH, which, in certain respects, can also be considered as hierarchically coordinated. Congress is able to exercise its vote in the formulation of tiie organizational objectives of NIH. Public representatives play a decisive role in the second stage of the selection process. Otherwise (in the MRC, INSERM, and the DFG), science clearly represents the defining power in funding policy and practice. Nonetheless, political representatives retain a fair degree of say in these matters. The strong participation of science in funding policy and funding procedures provides funding organizations with the necessary backing from the scientific conununity, and the concomitant information flow increases their chances of successf\illy promoting health research. The visible influence of science on the selection of proposals heightens the credibility of funding and creates acceptance for funding measures. At the same time, though, the strong position of science strengthens the relative autonomy of funding organizations from interests of political expediency. The more deeply that scientific representatives are involved in the formulation and selection processes at all levels of funding organizations, the greater the need for an array of coordinating procedures among government representatives, sponsors, and scientists before any final decision can be reached.

5.5

CONCLUSION CONCERNING THE INFLUENCE OF POLITICAL AND SCIENTIFIC INTERESTS ON STRATEGIES OF FUNDING AGENCIES

International comparison shows (if one disregards the position of private foundations) that basically two models of research funding can be distinguished. These models assign the funding organizations different roles and scope for formative input and provide political authorities with differently structured means of exerting influence. German federal

International Comparison of Health Funding Systems

extramural funding can be considered a hierarchical model of research funding. The relationship of the other funding organizations discussed to political authorities can be categorized as one of dynamic equilibrium. NIH has features of both models. Hierarchical coordination affords political authorities greater and more direct influence. Project-grant agencies have much less leeway in funding policy than do mission agencies.^ The everyday business of funding policy is largely implemented by the project-grant agencies. But not only does the ministry (BMFT) see to it that they act in its interests; it also considers itself the primary funding authority. Up until now, the project-grant agencies have been denied decision-making authority. Thus, in the case of Germany, hierarchical coordination means the direct and continuous involvement of political authorities (here, of a research ministry) in health research funding. In terms of many criteria, NIH also falls into the category of hierarchical coordination. However, in the United States, no department of research exists that would take legal responsibility for the formulation of funding and research policy in the same way as the BMFT does. There are a series of administrative authorities with differing (self-)interests in research funding. The DHHS itself is responsible for a set of very divergent tasks, which are in turn assigned to separate and relatively independent sub-departments. Thus, even though NIH is also part of the DHHS and thus falls under the direct responsibility of the President, its long-existing identity as a corporate actor in ttiis polycentric political-administrative system of research funding provides it with a great degree of autonomy. Since it is able to negotiate with Congress over financial resources, the President has less power to elicit accomodating behavior from NIH, for example by cutting appropriations. This makes NIH much less dependent than German federal funding on short-term government budgetary considerations. For a long time, the Congress proved to be more an advocate of health-oriented interests than a watchdog on behalf of presidential austerity policies.

72 The BMFT can issue directives to the project-grant agencies; it retains sole legal responsibility; the project-grant agencies are denied corporate status due to the temporally limited character of the Federal Program; matters of budgetary and personnel policy are settled by means of political-administrative procedures; and the Ministry is the ultimate decision-making authority in administrative questions and matters involving scientific or funding policy.

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The Role of Funding Agencies in Health Research

Accordingly, it is the legislative branch rather than the executive one that exerts political influence on NIH funding programs. In the course of annual budgetary negotiations, Congress is able to convey special requests or programmatic guidelines to NIH, which the latter is hardly in the position to reject. Thus, political authorities do possess influence, but this influence is not applied in an integrated manner; instead, it reflects the will of members of Congress, which is fragmented and frequently oriented strictly toward current problems. It remains up to NIH which members' requests it honors. Congress as a legislative body is not able to issue directives in the same manner that the BMFT does to its project-grant agencies. Its sole source of power is the use of annual budgetary negotiations as a control mechanism of NIH funding policy. The other funding organizations are less prone to political interference, though coordination with policymakers is still required. Here, scientific and political funding objectives are integrated rather loosely. This also holds for the relationship between the BMFT and German big science centers (BSC). With respect to the BSC the Ministry prefers a strategy of general guidance, giving ample room to administrators and scientists in these organizations to develop their own research strategies. Most of the major funding organizations in this area were established by political authorities, but they have their own legal identity and responsibility. There are no hierarchical relationships in this area, only mutual influence and the building of compromises. Political authorities possess institutionalized access to the committees of all funding organizations here; the financial dependence of funding organizations on public funds provides these authorities with a considerable threat of sanctions in any negotiations. This threat, however, is almost exclusively used only to reconcile the expansive interests of funding organizations with the budgetary limits of government. Little influence is exerted upon scientific policy. Political authorities appear to have a say in defining the general lines of orientation of the funding organizations. The transformation of this general framework into concrete funding policy, however, occurs strictly in terms of the internal operating rules of the funding organizations, and here, the decisive factor is the compatibility of funding measures with scientific criteria. Since political authorities are dependent upon negotiations in order to expand the range of their influence to specific areas, both the latitude that funding organizations have for self-definition and the influence of science is greater than under hierarchical coordination.

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From the perspective of the funding organization, the model of dynamic equilibrium is certainly preferable to that of hierarchical coordination. It allows greater autonomy and a funding policy oriented not strictly in terms of political interests, but also in terms of the specific problems arising in the scientific system. Thus, acting as a "trustee" rather than as a mere "delegate" grants the individual organization greater freedom in designing its own funding policy. The far-reaching integration of scientific representatives into their organizations provides funding agencies with an additional resource when they put their funding programs into practice: the extensive and intensive participation of scientists in the formulation of funding policies and in funding procedures provides the necessary flow of information from science and a high probability that funding measures will find widespread acceptance. Even if the funding organization pursues more application-oriented objectives, the integration of science provides the opportunity to make contact with science, and if consensus is reached, good chances for realizing such objectives. The successful promotion of research depends on the cooperation and trust of science. This simple conclusion is based on the realization that neither politicians nor the ministerial bureacracy nor even the sponsors are able to put political preferences into practice in the most adequate way, i.e., in a manner that harmonizes with the way that the scientific system works. The knowledge on how to do this resides by those addressed by such programs, that is, by the scientists themselves. At the same time, this realization points to a problem that political funding programs present the political system with. For it is certainly tempting to choose a hierarchical form of coordination between political authorities and funding organizations, since it guarantees these authorities a continuous and predominant influence on funding policy. In contrast, horizontal coordination, i.e., a system of dynamic equilibrium, allows one to influence, but not determine the contents of funding policy. A large degree of control over funding policy is likely to have a high price. There are, namely, four factors that can detract from the value of the hierarchically coordinated political promotion of research: • The "political-administrative logic" that marks politically organized research funding lessens flexibility in the shaping of the provisions of funding measures and increases the reaction time required by research funding. Political research funding is also subject to two different kinds

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The Role of Funding Agencies in Health Research

of "logic": it has to submit to both the procedural norms of administrative calculability and to the operating rules of science. And they are not directly compatible with one another. A funding policy that seeks to satisfy the demands of both has to make compromises and accept higher time costs. The advantage of funding organizations subject to dynamic equilibrium is that they are less subject to administrative logic, though not entirely independent of it. •

Funding activity that is part of ministerial policy is subject to struggles between government departments over allocations and to current budgetary policy to a greater extent than funding activity that is carried out by a relatively autonomous organization that receives basic-facility ftmding. This latter type of ftinding (and being able to consult with political authorities over appropriations within designated negotiating arenas) protects these funding organizations from politically motivated, spontaneous fluctuations in resource allocation. In contrast, under hierarchical coordination, there is great insecurity about the room for maneuver in designing future funding strategies, since it is difficult to predict the outcome of allocational struggles and budgetary policies. If the success of research funding activity depends upon the continuity of funding programs and measures, then hierarchical coordination provides a poorer basis than its horizontal counterpart. The politically motivated funding of research, which frequently takes place outside of the scientific mainstream, is particularly dependent upon the active dissemination of its programs, the persuasive labors of its sponsors, and the trust on the part of science that funding resources will be provided in a regular and generous manner. The cooperativeness of science can be put in jeopardy if any of these activities are disrupted by program restructuring or fluctuating resources. There is also another sense in which disruptions can more easily occur under hierarchical coordination than in relationships with less opportunities for policymakers to interfere. It is easier for different interests-via the legislature or other intermediating bodies-to succeed in shaping the funding policy of those organizations that are directly part of the political system (as are NIH and the German Federal Program). Hierarchically coordinated funding organizations have to cope more frequently with new and possibly internally inconsistent demands. This

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might not only jeopardize the coherency of the program, but can also lead to the situation where political infighting, rather than scientific requirements, allows certain parts of the program to expand at the expense of others. Such fragmentation will assuredly not increase the acceptability of the program in the scientific community. Of course, funding organizations with a trustee position are also not able to ignore preferences voiced in political and public circles. However, their relative autonomy and the strongly integrated position of science within these organizations prevents both their funding programs from being spontaneously fragmented and scientific interests from being neglected. • Finally, controlling the activities of funding organizations does not guarantee that political funding programs can be successfully put into practice. If it can be assumed that successful realization always depends upon the cooperation of science and funding finding acceptance in the scientific system, political authorities are faced with the following problem: They can secure control of the activities of funding organizations by opting for hierarchical cooperation (see Braun 1993e). However, in this way they jeopardize the participation of science in the realization of funding policy. Furthermore, it is possible they will have to accept lesser results from research funding than could have been achieved if they had opened their funding policy to discussion within the negotiating arenas of horizontal coordination. Thus, if politics is willing to accept the loss of control over funding organizations that this entails, it can be fairly certain that funding programs can be put into practice as adequately as is possible by means of its trustees. Thus, although politics might prefer hierarchical coordination, a more horizontal coordination probably offers it greater hopes of success. Though it is likely that some political conceptions will not be paid attention to, those plans that are accepted by funding organizations will probably also be successfully put into practice. The conclusion for funding agencies is obvious: A dynamic equilibrium grants considerably more room for maneuver than a hierarchical relationship with government, although this latitude is restricted in many ways. On many occasions the position of funding agencies is an awkward one: The intermediary position between political and scientific interests does not allow for independent and hierarchical decision-making within the confines of the

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The Role of Funding Agencies in Health Research

funding organizations. Instead, developing funding strategies is more often than not a triadic process of negotiation, with scientific representatives often as the defining actors. Incorporating scientific representatives improves the capacity of sponsors to select the most promising scientists and research fields and, hence, to raise the chance of being successftil. On the negative side of the balance sheet the incorporation means a loss of authority in formulating policy strategies. The incorporation of policymakers guarantees a continuous flow of ftmding resources needed to sustain the funding organization. Depending on the strategies of policymakers, it can also create disturbances in the design of funding strategies if research areas are targeted on account of political instead of scientific reasoning. Given these structural opportunities for outside actors to interfere with ftinding strategies, it is legitimate to ask if it is not more accurate to regard funding agencies as a policy arena rather than a corporate actor with its own goals and instruments. I think this would overestimate the importance of outside actors and underestimate the importance of the administrative staff working within the funding agencies. The statutes and organizational rationales of funding agencies create, moreover, a reference point of action no participant can ignore while participating within the decision-making process of funding agencies: The scientific administrator in the mission agency who refuses to promote the transfer of basic knowledge into application will be subject to financial and even organizational sanctions. The scientific advisor participating in strategic discussions is bound by a discussion framework that is defined by the tasks of the mission agency. In addition, all scientific representatives have to take full responsibility for their actions and their counsel in discussions with public and political representatives. Attempts to shirk such responsibilities, at the cost of public funds and at the neglect of political interests, would invariably result in financial curtailment of resources to the mission agency. On the other hand, policymakers participating in the policy formulation of funding agencies have an interest in the success of the funding agency and not in the exploitation of funding agencies for their own purposes. They are quite aware that unrestricted instrumentalization of funding agencies would, in the end, lead to the withdrawal of scientific representatives from the process and, hence, to a break in communications with the scientific system. There is, therefore, no unilateral decision-making power in mission agencies but, as the OECD maintains (1991: 7), a "complex political process involving many people who interact with one another. It is not a case of

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science-push or demand-pull, but a changing combination of the two that is impossible to break down precisely." Within this complex political process, sponsors take care of the organizational interests of funding agencies. They are the ones who carefully endeavor to guide funding decisions not merely in terms of scientific or political reasoning, but also in terms of a successful implementation of broadly shared funding aims. Thus in this respect, sponsors have a crucial role to play that is distinct from the interests of both political and scientific representatives.

6.

A COMPAMSON OF THE RANGE AND P R O B L E M - S O L V I N G ABILITIES OF DIFFERENT SETS OF FUNDING INSTRUMENTS.

This chapter takes up the funding instruments used by funding organizations to solve problems in health research, and especially in clinical research. Special attention is given to the diversification and range covered by the funding instruments as well as to the problem-solving abilities these instruments possess with regard to the challenges of health research. How differently are instruments used in the four countries? Which instruments appear promising? Does NIH also know how to turn the great scope of its formative powers to its own advantage when it makes use of its funding instruments? The chapter is divided into three sections. The most conspicuous difference between German funding organizations and those of the other three countries is the capacity of the latter to be intramurally and extramurally active within the framework of one organizational entity. I contend that the additional instrument of intramural research funding provides these organizations with qualitatively different ways to take action and is likely to result in a greater problem-solving ability. For this reason, a separate, introductory section is devoted to the effect of this intramural component on research ftinding. This is followed by a look at the range of funding instruments; the chapter concludes witii a depiction of the problem-solving ability of ftmding instruments in clinical research.

6A

THE ADVANTAGES AND DISADVANTAGES OF HAVING AN INTRAMURAL COMPONENT TO RESEARCH FUNDING

The term intramural funding is used here to designate the allocation of the grants of a funding organization to research units within its own organizational structures. The allocation criteria are defined by the funding organization itself. The relative size of the intramural component in funding agencies varies considerably: in NIH, it only makes up 10%; in the MRC 60%; and in

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INSERM, 90%. In absolute terms, however, the size of the intramural component is much higher in NIH than in the other two mission agencies.^^ What are the advantages of implementing intramural funding? • The reputation of a funding organization in the scientific community, and thus its chance of success, is determined by two factors: by its scientifically based review process of proposals for extramural funding and by outstanding research achievements conducted within its own organizational structures (the intramural component). The status as a center of excellence, often attained by mission agencies, is based upon such outstanding research achievements. Excellent research carried out within one's own organization shows not only that the given research council submits to the demands of science, but that it is also able to satisfy these demands in a competitive scientific situation. This brings with it the respect and recognition of the scientific community. The intramural component, i.e., one's own scientists taking part in health research, provides for the integration of part of the organizational life of a funding organization into the scientific system. By integrating research scientists into one's own organizational context and having them take part in the ftmding organization's decision-making processes, a permanent field of communication is created between the funding organization and science, which can be of service to the sponsors when they design their ftmding instruments. Thus, the key to success in the intramural component of the funding organization resides in the structural opportunity it provides for direct and unimpeded access to research scientists who are acquainted with and supportive of the research councils' objectives in research and funding policy. • Intramural research strengthens the position of the funding organization vis-^-vis the political authority financing it. Moreover, the demonstration of good research performed on one's own also increases the trust of political authorities: it shows that the organization is worthy of financial support, since it makes it easier to give visible evidence that the latter has

73 In 1989, NIH spent $782 million on intramural research, which is larger than the total funding expenditures made by any of the otherftxndingorganizations.

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expended previously allocated resources in an efficient and correct manner. Scientific recognition of intramural research can also be turned by political authorities into a gauge of their own success if the latter use it symbolically to convince the public of the efficacy of government spending policies. • There are also, however, concrete instrumental advantages. Having intramural research units at one's disposal allows exploratory research to be initiated in previously unrecognized scientific fields on relatively short notice. The funding organization with its own research units has the advantage of being able to quickly take up scientific or social policy problems, since it is not dependent upon the responsiveness of the institutional order existing within the scientific system. The intramural component frees one from having to direct funding resources at target groups outside of the funding organization, a strategy which is often relatively ineffective in the exploratory and innovative phase of basic research. After exploratory research is conducted within one's own organization, a call for grant proposals in the research field involved can then be made (the extramural phase). In this way, the effort is made to obtain the support of the scientific community in addressing the problem at hand. Finally, investigator-initiated grants make it possible to entrust the problem completely to researchers in the scientific system. • Intramural units also contribute to the funding of human capital in the scientific system. NIH has long been praised for its work in training physicians in science. All mission agencies view their research units as sites for training young talent; this also provides them with the opportunity of recruiting the best young talent for their own research activities. This important ftmction in the training of human capital also contributes to the general reputation of funding organizations within the scientific system. The set of funding instruments is thus strengthened in a host of ways by an intramural component: It improves the reputation of the funding organization within the scientific system and thus increases the scope of influence of its other instruments. Its exploratory use makes a better-informed, more flexible and innovative funding policy possible. Intramural research gives funding

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organizations a good tool for making a serious contribution to the initiation of new research fields and the acceptance of new disciplines. The implanting of intramural research units within universities, which is characteristic for INSERM and the MRC, also provides opportunities to form new structures in the scientific system (see below). However, a number of disadvantages can also be cited: • Since the intramural component strongly interlinks the funding organization with the scientific system, scientific interests necessarily play a greater role in the decision-making procedures of mission agencies. Even though this facilitates communication and the acceptability of measures, the initiation of problem-oriented funding and research measures that are scientifically not very promising can suffer as a result. In most decisions, scientific representatives within the funding organizations possess considerable veto powers (see above). • A central problem faced by INSERM and MRC is the self-perpetuating character of intramural research units. Long-term funding obligations for extramural research projects and institutionalization in the form of intramural research units commits the government financing authorities and the funding organizations to maintaining medium-term courses of funding. Funding organizations that fiind only extramurally and this, largely in the short- and medium-term, have shorter reaction times and better opportunities to reallocate their funding if they have sufficient room for maneuver.^'^ Both INSERM and MRC have had repeated

74 The situation of NIH is somewhat different from that of INSERM and MRC. First of all, the relative size of the intramural component, as mentioned above, is small. This means that there is a large enough maneuverable mass of funds in the extramural program to allow NIH to react to developments taking place outside of the organization. Secondly, NIH differs from INSERM and the MRC in its lack of research units. The intramural funding of NIH is organized in large institutes, which operate as corporate actors, investigate a comprehensive field of research, and are themselves in the position to make intramural reallocations of fiinds according to research topics and specific priorities. In a large number of the relatively small research units, this is more difficult, since the disbanding of such groups almost always provokes social and cognitive problems. The disbanding of a unit is often considered a sign of failure; it forces geographical mobility upon its members, who have to be integrated into new research teams

Problem-Solving Abilities of Funding Instruments

difficulties in trying to disband their research units in order to establish others in new fields of research. In order to defuse the concomitant social problems and to promote flexibility, INSERM introduced the 12-year rule, which requires all research units to reapply for basic-facility funding after 12 years (see more extensively Braun 1993a, Vol. 2). The MRC does not have a fixed funding term for research units. However, in the last several years, financial constraints have given rise to the practice of forcing units of deficient quality to close. Earlier, this seldom occurred, despite recommendations to the contrary. Research units were long spared from reallocation efforts (something which can be said for the other funding measures as well). Now, all intramurally and extramurally funded projects compete for the same scarce resources. A large number of permanently employed scientists does not have to lead to flexibility problems, if there are sufficient opportunities for changing positions. However, the highly specialized nature of biomedical sciences makes it increasingly difficult to change from one research field to another. Cognitive gaps arise between individual research fields, and they will only grow in the future. This practically unavoidable trend can probably only be dealt with by instituting a model in which funding organizations increasingly move away from making permanent appointments in intramural research. • The permanent appointment of intramural researchers creates a very high fixed share of costs for INSERM and MRC. They amount to almost 80% of costs at INSERM, for example, and thus considerably narrow the room in its program for extramural funding. This is also one of the reasons why new priorities and programs have to be realized by way of intramural-unit activities. Extramural programs play a subordinate role at INSERM. In sum: It has been shown that intramural research can improve or worsen the problem-solving ability of the set of funding instruments. It provides activities with a solid foundation in science and thus increases with differently structured research interests. The reallocation opportunities within the institutes and the in any case greater mobility of American researchers enables NIH to adjust to such problems relatively well.

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communication between funding organizations and researchers. It supplements extramural funding with the possibility of independently exploring research topics and problems. In this sense, it has an innovative function within scientific development. In addition, the organizational construct of the research team, characteristic for England and France, enables intramural units to be implemented as a structural instrument of funding policy. Indeed, in both countries, they represent the most important instrument for the diffusion of new findings in basic science. NIH does not have at its disposal such a structurally formative, intramural element within universities, but this also enables it to avoid the potentially self-perpetuating nature of research-unit contructs. In any case, the mobility of scientists is higher in the United States than in European countries: by providing for a regular influx and outflux of researchers at NIH, any problems involving the permanent renewal of institutional knowledge in research are eliminated.

6.2

THE

RANGE OF THE

SET OF FUNDING INSTRUMENTS

IN

HEALTH RESEARCH

Extramural funding in health research encompasses three major target areas in the four countries investigated: it seeks to ensure the (conditions of) continued existence of scientific research; it attempts to improve the quality of human capital and to integrate the latter into the scientific system; and it helps correct the topical one-sidedness of research projects and to remove rigidities in the institutional organization of research.

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6.2.1 Ensuring the Basic Preconditions of Research Safeguarding the basic preconditions for the continued existence of scientific research is one of the most important funding activities of the mission agencies and the DFG. Except in the case of NIH, such activity is always structured to be complementary to the basic-facility funding of research institutions. As mentioned above, there is so little basic-facility funding of universities in the United States that NIH and other funding organizations also finance the infrastructural prerequisites of research institutions. The activities of funding organizations in this field include: • Support for thematically specified and scientifically promising research projects. Here, the review of grant proposals serves to supplement the internal selection mechanisms of science. • Provision of technical facilities in support of funding projects (such as apparatus and machines). • Infrastructural support of research institutions (indirect costs awards, modernization). • Support for informational exchange (communications) within the scientific system. • Ensuring communication with foreign countries. Funding measures implemented in this target area belong to the incentive mode of funding, i.e., in the ideal case, research credit is made available strictly dependent on the quality of the grant proposals and their submitters and on the expected advance in scientific knowledge, and not tied to any demands on the part of the funding organization. The influence of the funding organizations is limited to motivating scientists to perform research and to supplementing basic technical and infrastructural prerequisites, where needed. Up until now, the use of indirect cost awards in support of research institutions has only been characteristic of the United States. Incentive-mode funding measures predominate in the DFG and NIH. The DFG expends about 50% of its resources in the bioscientific area on its normal grant procedure (Normalverfahren), exclusively based on incentive-mode funding; NIH's individual investigator award also accounts

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for about 50% of its extramural funding and about 37% of its overall ftinding (which thus includes intramural expenditures as well). The provision of grants according to purely scientific criteria of quality also represents the most important part of ftinding in INSERM and the MRC. However, in INSERM, almost 95% of these ftinds are provided within its intramural research program. Research teams are able to recommend their own topics within the grant procedure of the INSERM. Research teams are then selected according to the quality of the team and of its proposal. A large percentage of MRC grants are allocated in a way very similar to that of INSERM. Extramural ftinding, though, plays a larger role. MRC project grants, being designed according to the incentive-mode of ftinding, accounted for about 10.3% of all ftinding in 1991, but 25% of extramural funding (see more extensively Braun 1993a, Vol. 2). The BMFT does not consider it one of its tasks to contribute to the basic institutional and infrastructural prerequisites of scientific research within the framework of its extramural ftinding. It participates substantially in the basic-facility funding of nonuniversity research institutes and, on a minor scale, of universities. All of the ftinding organizations that were investigated have found it necessary in different ways to develop measures aimed at increasing the interest of clinicians and medical departments in scientific clinical research. In none of the cases, however, did incentive-mode research ftinding prove to be sufficient on its own. Naturally, clinicians, like any other scientists, can apply for funding within the framework of NIH's individual investigator awards, the MRC's project grants, the DFG's normal procedure grants, or, as part of a research team, for INSERM or MRC grants. Incentive measures may have had some effect on clinicians in times when funding organizations had enough funding resources. However, since the eighties, there has been an increasingly disproportionate growth in the number of grant proposals in relation to the low rate of growth of funding resources, and this has led to an enormous increase in competition for ftinding. In a time of scarce resources, there is always a decrease in the relative share of successftil grant proposals of physician-researchers as compared to those of biomedically trained researchers. There are three reasons for this: (a) since medical training frequently lasts longer than biomedical training, physicians are older when they first apply for grants; (b) their training provides them with less expertise in the basic sciences; and (c) in funding

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organizations' review processes, which are frequently dominated by biomedically trained scientists, they run into biases against clinical topics or have to meet scientific standards that are derived from the natural sciences and do not take the practically oriented training of physicians into account. Accordingly, in times of scarce resources, there is a high probability that the grant proposals of physicians will be rejected within the incentive mode of funding. Complaints were often heard from clinicians in France, England, and the United States about the unfairness of funding procedures in this respect. In order to defuse this situation, at least INSERM has introduced special measures. To motivate clinicians to participate in research, it has first of all established technical advisory groups for clinical researchers, service commun conseil en recherche clinique, aimed at counterbalancing information deficits and discriminatory practices. Secondly, it has approved a measure to make it possible for clinicians in particular to perform short-term experimental (pilot) studies quickly and without having to satisfy extensive requirements (contrats normalises d'Etudes pilotes). 6.2.2 Measures in the Field of Human Capital Funding organizations consider it one of their primary tasks to train young talent in science and provide individuals with incentives for entering into or remaining within the scientific system. The BMFT sees itself compelled only in part and on a minor scale to create training opportunities for young scientists. Indeed, this was originally not even one of the aims of the Federal Program. The BMFT nevertheless does make some efforts in this area, since it is the only way to specifically and above all permanently eliminate deficient areas of science (as in the case of the AIDS-fellowship program of the German Cancer Research Center or in the field of epidemiology and rheumatology funded by the German International Academic Exchange Program [DAAD]). For this reason, the distinction has to be made between two types of ftinding activity: one aims to integrate the qualitatively best young scientists into the scientific system or to keep the qualitatively best scientists and clinicians in research, the other attempts to draw a critical mass of researchers into an area deficient in research. The DFG primarily concentrates on the first area. It uses scholarships and several special programs (such as the Gerhard Hess Program) to help in the

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selection of outstanding young researchers and to ensure the existence of satisfactory research resources for these researchers. It has no measures in the area of human capital tailored to definite deficient areas of research. Mission agencies employ human-capital measures in pursuit of both objectives. In the extramural funding of human capital, NIH is the funding organization with the most diversified set of instruments. It distinguishes itself from all other funding organizations through its array of measures, which cover practically every phase of activity in a life of research.^^ These measures are also open to physicians. However, NIH also has a great number of funding measures specifically aimed at developing young talent in medicine and keeping trained physicians in research (such as the clinical investigator award, the individual physician scientist award, and the physician scientist award). The range of NIH funding activities is further extended by the availability of intramural facilities as described above, in which NIH can train young researchers and medical students as well as prospective physicians within its own institutes and at its Clinical Center, For this purpose, a separate funding program was designed for postdoctoral candidates (intramural NRSA individual postdoctoral program appointees). NIH's human-capital measures are marked by a series of special features, which combine to make it easier for physicians to conduct clinical research: • The strong emphasis on funding measures tailored to institutions; • The great number of funding measures specifically aimed at developing young talent in medicine and keeping trained physicians in research; • The opportunities provided for researchers, even later in life, to change careers; • The array of measures covering every phase of the life cycle; • The opportunity open to clinicians to let themselves be trained for several years in basic research and then to return to their positions at medical schools or hospitals.

75 Thus there is a special measure for young researchers who do not yet have any research experience and who receive special support; measures for improving research training; incentive measures to keep researchers and physicians in research; and a measure that allows good researchers to change careers from one research field to another.

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INSERM chiefly makes use of its intramural construct in order to provide young researchers (as well as young physicians) with scientific training. In recent years, it has also taken special measures for clinicians. Research at the units is always open to young scientific and clinical talent. In 98% of these research units, positions have been established for this purpose (see more extensively Braun 1993a, Vol. 2). A limited number of medical students have the opportunity to receive training at the units during the year of research they are required to conduct in the later phase of the university career path (the diplomed'etude approfondie or so-called DEA). In addition, clinicians who already work at hospitals have the opportunity, via the pastes d'accueil, to devote themselves entirely to research for a period of time. The dimensions of this measure are still limited, however. The greater importance of extramural funding has led the MRC to develop a much greater number of extramural human-capital measures than INSERM; nonetheless, it makes just as many research positions in its research units and institutes available as do the other two funding agencies (for details, see Braun 1993a, Vol. 2). The MRC explicitly distinguishes between clinical and non-clinical measures for funding human capital. Here, its measures place emphasis on research scholarships for graduate-level candidates. Like the other two research councils, the MRC also has a measure to enable scientists and explicitly physicians to be freed from clinical activities for a limited period of time in order to be able to exclusively conduct research (a year of leave for research, similar in form to the DFG's program). The MRC has also developed clinical scientist fellowships, aimed specially at young clinical scientists to allow them to conduct several years of basic research and then to return to the hospital. Moreover, intercalated awards give medical students the opportunity to voluntarily conduct an additional year of research during their studies.

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6.2.3 Measures for Influencing Thematic Eliminating Institutional Rigidities

Orientation

and

Deficits are brought about in the scientific development of every country by the social and cognitive structure of science and the organization of research. Apparently, nowhere does the social organization of science adjust to changed environmental conditions and changes in the research process without friction. Thus, eliminating such deficits represents one of the central responsibilities of funding organizations. Two kinds of funding can be distinguished with the following respective objectives: Program-oriented Junding • Targeted funding of a scientific field that has been neglected by science, but which offers a means to approach scientifically promising problems or socially relevant ones. Structure-oriented Junding • Support for the establishment of disciplines that are not able to develop within existing disciplinary structures; • Funding for team-linked research; • Funding for interdisciplinary research; • Funding for the transfer of findings from basic science into application systems; • Active adaptation of the institutional framework conditions of research. Program-oriented and earmarked funding presents funding organizations with the opportunity to convert their priorities in funding policy into practice in a goal-oriented way. Here, the motivational component that characterizes incentive-mode funding (i.e., the provision of research grants by funding organizations without the setting of conditions) is joined by a regulative component (for a discussion of these terms, see Scharpf 1983): researchers and research institutions are expected to submit grant proposals and conduct research within the thematic scope developed by the funding organization. Thus, "regulation" here refers to the selective limitation of the initially

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unrestricted latitude of the researcher in the selection of his or her research topic. And it is the funding organizations that make this limitation. Program-oriented funding can be supplemented by structural goals. Thus, even though grant proposals are always called for in a specific thematic area in the framework of the directed funding activities of the German Federal Program, for example, in most cases, such calls for proposals also seek to initiate cooperative and interdisciplinary research and new structures in the research world. The target-area (or priority) programs (Schwerpunktverfahren) of the DFG and the program project grants of NIH also combine funding for deficient areas of research with the requirement of cooperative research. MRC's new research initiatives fund deficient research areas and the core elements of new structures. INSERM, in principle, does not adopt any program-linked measures. However, a certain substantive selection in the acceptance of new research teams does in fact occur by means of the adoption of a framework plan (rapport conjoncture), which provides the review commission with substantive assistance in the selection process. Additionally, the inter-commissionsscientifiquesspecialisees were established to encourage the development of deficient areas of research (see more extensively Braun 1993a, Vol. 2). The number of these commissions is very limited, however. Program-oriented instruments primarily serve to underscore the priorities of funding organizations. Structurally oriented instruments can serve either to support other instruments by creating the institutional and infrastructural prerequisites for carrying out certain programs or they can take up specific organizational deficiencies of science and attempt to adjust the social organization of science to the new requirements it faces. As has been shown, structural measures can be complementary activities or represent the main purpose of a funding project. In the former case, substantive and structural orientations are equally emphasized, whereas in the latter, the substantive orientation becomes secondary. Three target areas are central to structurally oriented measures: simple cooperation between researchers from the same disciplinary area but from different institutions (as in the DFG target-area program), interdisciplinary cooperation, and the transfer of basic knowledge into user systems. All funding organizations have developed instruments, the majority of which aim to create interactive facilities for research that go beyond local.

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disciplinary, or systemic boundaries. Such interactive facilities are to lay the basis for structures that can reduce the cooperative deficits in the future. NIH's center grants, the MRC's interdisciplinary centres and especially MRC's and INSERM's own intramural units can have this structurally formative effect at the universities (see below for greater detail). The DFG's special research fields (SRF) should also be cited in this context. The BMFT largely makes use of structurally formative measures within its program-oriented funding. However, it has also successfully initiated research networks in the field of AIDS research and clinical research teams (Klinische Forschergruppen) via the DFG (the latter for the purpose of improving the basic conditions of clinical research; see below). Since we are especially interested in the problem-solving abilities of these structurally oriented measures in successfully converting molecular-biology findings into clinical research practice, this will be taken up at length in the next section. In sum: The overview of the range of the sets of funding instruments in the four countries studied demonstrates that the health funding agencies are active in all three target areas. In the United States and France (and in the funding of the German DFG) the focus of activity is placed on the incentive mode of research funding, whereas in England the growing scarcity of financial resources in recent years has resulted in a turn to program-oriented funding (see extensively Braun 1993c). In spite of the clear predominance, both in priorities and in the use of funding instruments, that funding agencies place upon ensuring the basic preconditions of research, they are all willing to make specific efforts at eliminating deficits in the scientific system. NIH has had effective instruments for doing just that for a long time. In contrast, it is only in recent years that priority has been given to transfer-related extramural measures and greater emphasis within one's own research teams to such transfers in France and England. However, group-linked cooperation has traditionally always been the basic principle underlying intramural research units. The German Federal Program arose as a problem-oriented funding program and primarily directs its energies at correcting substantive one-sidedness in scientific development and eliminating deficits and rigidities in the scientific system, with the transfer of knowledge into the health care subsystem representing its chief aim. Thus, in all the measures of the

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Federal Program, structurally oriented - and here, especially transfer-related measures - play an important role. Taken as a whole, however, the set of instruments implemented in German federal funding have for a long time had the narrowest range: measures aimed at providing and maintaining the institutional and infrastructural prerequisites of research are not part of the spectrum of tasks taken up within the Federal Program. Moreover, the principle of subsidiarity makes it difficult to become independently active in areas where other organizations are already funding. Only recently a strategic turn to a more structurally oriented funding has enlarged the scope of funding activities. The new instruments are especially designed to improve productivity in clinical research.

6.2,4 The Problem-Solving Abilities of the Set of Funding Instruments Applied to Clinical Research The range covered by a given set of funding instruments only reflects the emphases of the given funding organization and the diversification of this set only reflects the number of problems it seeks to address. It has already become clear that every funding organization has developed structure-building instruments of some kind in order to promote the transfer of basic knowledge into user systems. The question aised in this section is: how successful have the structural instruments, employed in particular in the United States, France, and England been in handling the transfer problem of clinical research?

6.2.4.1 The Problem-Solving Abilities of NIH Funding Measures in Addressing Clinical Research Deficits. Even in the United States, in spite of the high priority that research enjoys at elite universities, interactive facilities for the transfer of basic biomedical research into clinical research do not appear to be simply a given. This is seen in the fact that even NIH has for some time now developed measures aimed at stimulating the creation of such interactive facilities.

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NIH fiinds various center grants (for example, the specialized center grant and the comprehensive center grant); of these, the General Clinical Research Centers (GCRC) program is aimed at providing for the transfer of basic research into the hospital. The medical schools which are willing to integrate such centers into their programs receive money to finance the infrastructure for clinical research, which consists of technical personnel, a coordinating administrative staff, and a small ward solely reserved for research purposes.^^ The grant is given to the institution willing to integrate the center into its existing structures. The funds for the actual research projects then conducted at the center have to be acquired by the researchers themselves by means of normal grant procedures. Thus, the center grants themselves only provide structural support. NIH's basic aim is to use this structural funding to bring together researchers from different disciplines, i.e., to initiate multidisciplinary research at the intersection of basic research and application. About 4,200 research projects are now conducted by the 6,500 researchers working at such centers (Vaitukaitis 1991: 145). Two points should be noted here: first of all, the period of funding for the centers can run up to 20 years. This satisfies a necessary prerequisite for making such structural facilities attractive: the behavioral expectations placed on interdisciplinary research have to be of an especially long-term character, in order to convince researchers that it actually pays to make a change from one credibility cycle to another. More than a few years are needed to establish a new direction in research, a new discipline, or a critical mass of researchers. And this has been recognized by most funding organizations.^^

76 "The GCRCs provide the clinical research infrastructure to facilitate clinical research—the specialized research nurses, research dietitians, research facilities for both inpatient and outpatient studies, including their research ancillary costs. In addition, GCRCs provide biostatisticians, computer systems managers, computer hardware and software for graphics, database management and analyses. Many GCRCs have laboratories for many sophisticated technologies..." (Vaitukaitis 1991: 145).

77 The DFG provides funding for 15 years within its special research fields (SRF); the institutes of the Max Planck Society are supposed to have about the same life span; INSERM provides its research teams with a 12-year term; and the MRC research units often work together for 20 years.

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Within this program, an evaluation by NIH is supposed to occur about every 5 years. Since, however, this only involves an assessment of the scientific efficiency of the structure evaluated, this in no way undermines the faith of the researcher or physician in the readiness of the funding organization to provide long-term support for such interdisciplinary research. Quite the contrary: regular evaluation has an integrative effect on the participating researchers. In a certain respect, the participating scientists and physicians at such centers even become "prisoners" of this game. Only their common achievement decides whether a center's grant will be renewed or not. The researcher who is not ready to invest in the work of the center thus punishes all other researchers who are interested in the center having its grant extended and has to reckon with negative sanctions. For this reason, there is a high degree of social control over the researcher's performance at such centers. Moreover, the evaluation and even the recognition of such a center is primarily based upon research achievements, proof of cooperative capabilities, and the interdisciplinary character of the proposed research program. Thus, outstanding individual research achievement is in no way suffient; decisive is only collectively produced, innovative research in a given area. Thus, both mutual interdependency of all participants on the performance of others and the necessity to cooperate serve to satisfy the standards of NIH and, in this way, contribute to the permanency of such arrangements. However, once again emphasis has to be placed on the especially favorable institutional order existing in the United States, which facilitates the creation of such centers. Since most researchers in the United States are dependent upon grants and medical schools and hospitals are very interested in such centers (due to the additional financial resources they provide and the opportunity they give to ftirther strengthen one's reputation as a center of excellence), NIH is able to initiate and finance such centers without many problems. It rarely has to make an effort to find researchers ready to work in such hospital centers or institutions ready to integrate such centers into their structures. Moreover, the decentralized decision-making structure of American universities and hospitals makes it relatively easy to establish such centers. Above all, though, the high degree of mobility of scientists and physicians inherent to the American system represents a necessary precondition for the diffusion of the ideas and forms of cooperation developed at the centers.

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Thus, in the United States, there is a very high probability of successfully converting research in molecular biology into clinical research and application because the high degree of mobility and the accompanying diffusion of knowledge in this country allows new disciplines and paradigms to arise much more rapidly than in Europe (see also Ben-David 1971). Thus the range of NIH's set of instruments is increased by these structural features: There are no major problems associated with the creation of new transfer centers (as long as there are sufficient funds and qualified scientists can be found). Once they are established, they exhibit few centrifugal tendencies and therefore enjoy, if they are reviewed favorably, a relatively long institutional life. And finally, relatively few centers are needed in order for the measure to promote the greatest possible diffusion of knowledge and methods. Moreover, in addition to these extramural measures, NIH also possesses the unique construct of the Clinical Center in Bethesda, whose entire staff of physicians is involved in research and to which only patients of special interest to research are admitted. NIH is able to set an example in the transfer of research from molecular biology into the hospital through its intramural research as a whole, but especially by means of this Center.

6.2.4.2 The Problem-Solving Abilities of MRC Funding Measures in Addressing Clinical Research Deficits. The MRC primarily uses its research units and the Clinical Research Centre (CRC)^^ as structural instruments for implementing transfer-related goals. In recent years, repeated evidence has been brought forth showing that these instruments are inadequate for advancing clinical research and especially for promoting the diffusion of the research findings of molecular biology. This has now led to the clinical research initiative measures and the establishment of a series of interdisciplinary centers. Only a small percentage of the approximately 50 research units have been used to carry out the transfer function. It has been estimated that about 10%-15% of the units are involved in clinical research. Despite the implantation of units into hospitals, there has been little success in

78 The Clinical Research Centre will be dissolved in 1994 (see below).

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establishing cooperation between clinicians and basic researchers in biomedicine. The implanted research teams remained largely isolated. This shows the relatively unadaptable character of the institutions of the English university. The implantation of structural "core units" can only function if physicians are granted sufficient time to conduct research, and the institutions are willing to provide corresponding infrastructural support. It does not represent a measure with which the unequal allocation of resources in medical departments and hospitals could be corrected; it only provides clinicians with unique opportunities which they can take advantage of. A key incentive mechanism for getting clinicians to devote themselves to research was largely lacking, however: the institutional self-interest of medical departments and hospitals in scientific clinical research. Such a construct clearly does have instrumental advantages, with such research teams attracting attention and serving as a model in Germany for clinical research teams. For research units represent structural measures in the very way they are organized. Nevertheless, they only function by means of the cooperation between biomedical scientists and clinicians. If they are placed at hospitals or in medical departments - and this is always true in France and usually so in England - they are able to set an example, especially in structural terms. By functioning as models, they can certainly set off a process of transforming previous structural rigidities, if the scientific system allows a high degree of diffusion. Such units can be especially useful to clinical research, since they provide the necessary research infrastructure in the form of laboratories and findings from basic research that are often lacking in hospitals. They are accessible to the clinicians in medical departments and hospitals. Clinicians are themselves often pressured to take charge of such teams, so that direct contact can be established to patients. Nevertheless, such participation by clinicians remains in both England and in France more the exception than the rule. Even the Clinical Research Centre (CRC) of the MRC has proven incapable of paving the way for transfer, even though it was explicitly established at the beginning of the seventies to promote clinical research. It will be dissolved in 1994. The distance between the CRC researchers and the clinicians at the nearby district hospital was never overcome. One of the main reasons for this was the lack of time set aside for research at the hospital: patient care demanded too much of the attention of clinicians, who were not selected on the basis of scientific criteria anyway, and it hardly

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allowed for any intensive cooperation between them and researchers (for details, see Braun 1993a, Vol. 2). Only Hammersmith Hospital currently enjoys general recognition as a promising construct for transfer, especially after basic research is strengthened by the future integration of the research teams of the CRC. Hammersmith is a teaching and research hospital exclusively reserved for post-graduates that primarily conducts patient-oriented research. Departments are headed by scientifically trained physicians, which is unusual in the English system. Hammersmith has been known for its outstanding clinical research for years. However, here too, there is only the beginnings of transfer; the incorporation of CRC teams aims to improve this. Its continued part in the regional care system and the concomitant outpatient care this requires represent the only drawbacks of this construct as time resources for research become scarce. This teaching hospital is basically modeled upon the American version of a clinical research center. Its chances for success appear to be guaranteed by the following key elements: the hospital's departments are run by physicians from the university medical-department staffs who are interested in research; these medical departments themselves correspond to the graduate-school model; though patient care is provided, the focus is clearly on its research aspect; and finally, research laboratories and basic-research teams are in direct proximity to patients. In combination, this makes it likely that there will be a difftision of the findings of basic research throughout the hospital and its routines. The MRC has also come to view the creation of centers in general as the correct funding concept for transfer. In doing so, it hopes not only to promote cooperation between researchers from different disciplines, it also hopes to be able to make research less expensive by concentrating it at such centers. In times of scarce resources, this becomes increasingly important. Whereas the MRC previously funded relatively permanent institutional constructs, such as the CRC and its other institutes, it moved away from such long-term funding in the eighties and limited itself to medium-term funding. Thus, new centers are now funded as extramural units, receiving a certain period of ftinding after which they will have to arrange for their own provisions. The overall clinical research initiative of the MRC is designed in the following way: the interdisciplinary centers are explicitly employed to improve the interlinkage between basic research and clinical research. The

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basic idea is more or less the same as the idea of the center in the United States: the MRC finances interactive facilities for research, for example, at a hospital. Funds are approved for the administrative and infrastructural costs of such a center. Researchers who would like to work there are then required—as in the case of the NIH—to provide themselves with additional funds by means of special project grants. The advantage over the normal unit construct is not merely the provision of a clear time frame after which the centers have to be financed through grants or other forms of basic-facility funding, but also the fact that clinicians and researchers have to propose and work on such a project in unison. Thus, the construct of the center lays the foundation for the joint action of actors from different social systems. The idea of the research "hotel" is also similarly designed. This construct provides not only for transfer into clinical research; it also emphasizes transfer into the health care subsystem and private industry: researchers from universities, foundations, and private industry are offered the opportunity to conduct research under one roof and to use the same infrastructure (financed by the MRC and other funding organizations) and know-how from selected scientists. The individual research teams do not have to work together, but their research topics should be similar enough that their knowledge proves complementary to one another. This should make it possible to reach the chief objective of these "hotels": application and utility. In sum: English funding policy is thus presently marked by a reorientation in the use of its set of instruments, which aims to markedly improve the ability of funding to solve the problem of transfer. The reorientation strengthens the extramural component at the expense of intramural funding and the active mode of funding (goal-oriented, programmatic, and structurally oriented measures) at the expense of the incentive model. Though the research-unit construct clearly has its advantages, it proved inadequate for resolving the problem of transfer. It was especially hampered by the relative isolation of such teams at universities and hospitals. The structural instrument alone cannot create a permanent connection between the roles of basic researcher and physician, anchored as they are in different social systems. This is the reason why the switch was made, some time ago, to the ftmding of centers, a strategy modeled on American practice. The interdisciplinary centers and support for the Hammersmith Hospital—m harmony with a coordinated funding initiative to eliminate deficiencies in clinical research-represent the outstanding examples of such a policy.

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6.2.4.3 The Problem-Solving Abilities of INSERM Funding Measures in Addressing Clinical Research Deflcits. Though France also moved in the direction of the center construct, INSERM has remained loyal to intramural funding, with which it still seeks to effect transfer. Since INSERM, unlike NIH and the MRC, does not have any of its own institutes, the incorporation of the units into the hospitals and university medical departments is its only way to conduct research. INSERM was able to come to a basic agreement with the agencies financially responsible for the hospitals at the start of the seventies, allowing it to implant its own research teams into hospitals. Nevertheless, the research teams remained foreign bodies at these institutions. The research environment was frequently just as hostile as in England. Occasionally, it was possible to get clinicians to participate in such research teams. However, due to the great attractiveness of patient care for clinicians and other structural limitations, diffusion effects remained small and have not yet been able to stimulate transfer to any appreciable extent. This is also one of the reasons why INSERM has pushed for a new contract with the responsible hospital authorities of lie de France in which hospitals are more clearly obliged to participate in the support of research than was previously the case. The aim here is to improve the integration of the units within the hospitals. A first attempt at putting the center construct into practice has already been made in nutritional research. This effort pursues the same goals as in NIH and MRC. The establishment of further centers is in preparation. INSERM makes greater efforts than the other funding organizations to integrate the key actors in the health care subsystem (thus, for example, the medical professions and medical associations) within a cooperative structure (the comit^s d'interface). The aim here is to enable research to respond more quickly and more specifically to problems in the health care subsystem. At the same time, the communication provides for better understanding of research among the actors in the health care subsystem. By comparison to the United States and England, the efforts of INSERM in extramural funding are limited. The steps referred to here were largely taken in order to improve the transfer capacities of the research units. In sum: The range of INSERM's set of funding instruments stands or falls with the effectiveness of the units and the modification of the research environment. In France, it is not possible to move flexibly between

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extramural and intramural components. But this need not necessarily weaken the chances of successfully translating basic research into clinical research. More decisive in this context is the extent to which influence can be exerted upon the research environment by means of structural constructs and a favorable research environment can be created. Here, however, France exhibits the same negative features of a patient-care-oriented system as do Germany and England. Since INSERM makes almost no use of the incentive system of extramural funding, it requires other kinds of strategies for influencing the conditions of research. INSERM seeks to do this by communicating and reaching compromises with the most important actors in the health care subsystem. Though such a step is no guarantee for resolving the transfer problem, it has increased the sensibilities of the actors in the health care subsystem, and in a certain sense, even put them under a moral obligation to support research. In the long term, this might very well be the only way to provide transfer with a chance of success in France. 6.2.4.4 The Problem-Solving Abilities of German Funding Measures in Addressing Clinical Research Deficits. With its special research fields (SRF), the DFG possesses a center-like construct, which has, however, only rarely been specifically applied to the problem of transfer in clinical research. Instead, hopes have been placed in recent years on the effects of clinical research teams. These teams have been set up by a joint effort of the BMFT and the DFG at the recommendation of the Science Council. As of the summer of 1993, the BMFT had financed 17 such clinical teams. The DFG has taken over the task of selecting and evaluating these teams. The teams are basically set up according to the example of the research units of the MRC in England. One difference, however, is the requirement that the head of the team must be given a professorship at the medical school in question. This has been done in order to both get clinicians of a high quality in research and in order to create structural core units for the development of clinical research within medical schools. After 6 years of research, funding is terminated and the medical schools are obliged, in case of a favorable evaluation, to finance the clinical team for an unlimited period of time. Whether they can be better integrated in this way, remains to be seen. One disadvantage of such a construct could be that, when the funding period ends, the clinical research teams become directly integrated into the normal allocation procedures of medical departments; if the environment is hostile

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to research, it would have to reckon with the loss of its previous infrastructural advantages. In this sense, the INSERM and MRC research teams are more secure, since they remain a part of the funding agencies and can expect the permanent support of the latter. As this is a very recent flinding measure (the first teams were set up in 1990), it cannot yet be ascertained whether the establishment of clinical research teams has actually improved clinical research. The first four teams, which have now been evaluated after three years of research, report that the communication between scientists and clinicians is functioning quite well. However, given the minor success achieved by research teams in France and England in regard to the transfer problem, it is not advisable to be too optimistic concerning the structural implantation of clinical research groups in German medical departments. In a generally unfriendly research environment, the success of such a structural instrument is often dependent upon purely contingent factors, such as the willingness of individual physicians and researchers to work together. Three other initiatives have been taken in Germany for purposes of improving clinical research: • The BMFT has restructured its Federal Program on Health Research in favor of structural instruments, i.e., rather than emphasizing programmatic areas of interest to the Ministry, stress instead has been placed on the improvement of the structural conditions of clinical research in general. A whole series of interdisciplinary centers for clinical research at university hospitals are planned, which are closely modeled on the U.S. center prototype. They have four objectives: (a) the establishment of efficient structures for clinical research at an interdisciplinary level, (b) the development of research with a specifically university character, (c) the expenditure of federal and state research fimds according to quality criteria, and (d) increased transparency in the financing of research, patient care, and teaching at university hospitals. • In the wake of German unification a new big science center, the Max DellbrUck Center for Molecular Medicine in Berlin-Buch, has been established with the specific aim of becoming a center of excellence for the transfer in question. The Center will have a direct link to hospitals in order to exchange knowledge regarding patients. • Finally, several of the BSC dealing with health research have set up a clinical association which aims to gain access to the clinical wards at

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university hospitals for BSC basic researchers. Some arrangements have already been concluded. It can be seen that German policymakers and sponsors have realized that the kind of funding measures they had made available were not sufficient for overcoming the deficiencies in clinical research in Germany. During the last few years a number of initiatives have, therefore, been taken which could have a positive effect on clinical research in the future.

6,3

FUNDING MEASURES: SOME CONCLUSIONS

In terms of improving the transfer of basic biomedical knowledge into clinical research, differences exist in the problem-solving abilities of the various sets of funding instruments available in the different countries investigated. In contrast to the German funding agencies, all mission agencies can make recourse to the instrument of intramural research. This allows them to act more quickly, more flexibly, and in a more innovative way in their funding practices. The way NIH organizes its intramural research into institutes distinguishes it from the research councils of the MRC and INSERM: it allows NIH to avoid a negative aspect of this instrument, namely, the ability of small, intramural research units to perpetuate themselves beyond the time of their usefulness. Moreover, NIH has another advantage over all other funding organizations. The high receptivity of the structures of the American scientific system for grant-funding measures in general facilitates the implementation of its funding measures: both individual researchers and their research institutions are interested in grant monies. This makes it easy for NIH to link its funding measures to certain conditions and demands, without having to fear a decrease in grant demand. This high receptivity in many cases also frees NIH from having to actively seek approval and institutional cooperation, something quite typical in the European context.

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The establishment of clinical centers, a funding measure which has been functioning well for some time now, has proven to be especially favorable for transfer under these conditions. The center construct has now prevailed in the other three countries as well as an important funding measure for establishing a well-functioning system of transfer. The advantages of such a construct are apparent: • Centers are established for a relatively long period of time. In this way they reduce the fears of many scientists and clinicians of not having enough time to create a secure reputation in an interdisciplinary field. • The funding of the centers is focused on providing it with its own infrastructure. This gives the research enterprise a certain degree of independence from the internal organizational decisions of the host institution. And this allows interdisciplinary research to be organized, even in an environment unsympathetic to research. • Those participating in the centers are all "prisoners" of the same game. The continued existence of the centers is dependent upon its overall research performance receiving positive review. Thus, any investigators who intend to conduct research at such a center have to take part in interdisciplinary research and be willing to cooperate with colleagues. • And finally, there is a favorable cost aspect involved: centers concentrate resources and research efforts and shorten information channels. The success of such centers in Europe, though, could be limited by two factors: The first involves integration: the French and English research teams, for example, remained relatively unsuccessful because they were not able to develop in an environment hostile to research. The question is to what extent the new centers will ultimately succeed in becoming better integrated in the long term. The second restriction involves the lower capacity for diffusion within the European (as opposed to the American) scientific system. The rate of diffusion of knowledge is determined by the mobility of researchers, since they are the ones who have to bring thefindingsand methods of a center to other locations. Beyond the willingness to be mobile, there are a series of structural prerequisites. These include a sufficient number of positions in as many places as possible within the scientific system as well as universities

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and other research facilities that compete with each other and whose decision-making processes are decentralized enough in order to be able to make attractive and competitive offers to qualified scientists. These preconditions are not satisfied in any of the three European countries studied (see also Ben-David 1968). The Hammersmith Hospital in England could develop into a model for other centers in Europe. It was shown above that the MRC and other actors have sought to establish several basic organizational patterns at this hospital that are highly promising for good clinical research and successful transfer. These patterns include the administration of patient wards by clinicians interested and trained in research; participation only by post-graduates; the priority of research, even in patient care; and the direct integration of research laboratories and basic-research-oriented investigative teams into a patient setting. In any case, it appears advisable in opening centers in Europe to incorporate the methods of INSERM: it made intensive efforts to establish contact with the key actors in the health care subsystem in order to reach a coordination of interests that can ultimately lead to the acceptance of these structures in hospitals and university medical departments.

PART 4 An International Comparison of Public Health Research and its Funding

7.

PROBLEMS OF PUBLIC HEALTH RESEARCH

Given the challenges and dynamics in health research it was concluded in chapter 3 that scientifically grounded activities were needed in the area of public health. One of the biggest problems in all the countries investigated is, however, that one will hardly find any secure scientific foundations. The approaches in research - frequently they cannot yet be called disciplines rarely have definite boundaries, neither in terms of topic selection nor of methods and procedures. Various disciplines which arose in other contexts find themselves in a struggle for supremacy in public health research. Many areas still lack research scientists. Often, there are not yet any organs of publication that could serve as a general forum for scientific discussion. The research infrastructure is underdeveloped and opportunities for special training are largely lacking. All of these aspects point to the fact that coherent scientifically based action is just beginning to take form. Public-health research still finds itself in a highly exploratory stage of scientific developmentJ^ The lack of a powerful unifying approach among public health scientists is combined, moreover, with a weak position in universities when it comes to the distribution of resources and a low status among public health research funding agencies and policymakers.

79 The cognitive development of research fields can be divided into three phases. In an exploratory phase of scientific development, no unified program of research yet exists. Research is confined to outlining the contours of its subject matter and classifying the latter (frequently descriptively). Theoretical problems are dealt with in terms of an array of theoretical approaches, and research is still largely subject to a procedure of trial and error (see Van den Daele et al. 1979: 42). As soon as a paradigm emerges (i.e., a theoretical model promising coherence), the research process develops its own dynamic, proceeding according to a scientifically immanent logic of development. The attempt is undertaken to integrate the various problems posed and approaches followed into a stringent pattern of explanation and investigation. Pluralism in research makes way for the pursuit of unity within the discipline. Only when the paradigm is established and such unity has thus been reached, does a process of diffusion of the paradigm into new areas begin. The generalizability of the new explanatory approach is tested, so to speak.

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It is this combination of an exploratory and fragmented area of research, a weak position in the university and a low status among creditors which makes it so difficult to establish the scientific foundations needed for informed action in public health. One could argue that this statement does not do justice to the differences in scientific performance between the United States and European countries. Without any doubt, the research activities in public health are much more intensive and comprehensive in the United States than in the other three countries. This can be ascribed to an institutional foundation in the United States that includes 27 public health schools and quite a few government research institutions and epidemiological centers. Public health, moreover, was already incorporated in the American university system by the 1920s (see Fee 1987), while it was banned from the scientific tradition in Germany during the Third Reich and recovered only slowly afterwards. Public health has, despite the tradition of Pasteur, been neglected in France until today. Only in Great Britain is a somewhat stronger tradition of public health found, due to the national health care subsystem. The extent of the integration of public health within the university in the European countries has been limited to the establishment of sections within the medical departments and only a few autonomous university departments and nonuniversity centers. In none of these countries, however, and this includes the United States, has this led to the emergence of a unified science of public health based on a general-population-related paradigm. And experts in all countries complained about their difficulties in obtaining sufficient resources and setting up the interdisciplinary research needed in public health. How is this retardation in the development of a coherent public health discipline, despite the long tradition of public health measures and public health research, to be explained? In this chapter three major reasons for this will be discussed which can shed light on this question: • First, there is the obstacle for public health sciences of being, like clinical research, a research area in between (several) basic sciences and the practical applications of the health care subsystem. The transfer of basic science knowledge into practical application is, however, even more demanding than it is in clinical research. The experiential knowledge of several quite different research traditions has to be combined within an

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interdisciplinary approach in order to conduct successftil research. I will show why this causes difficulties. Second, there is strong competition with medicine that is even fiercer in character that that between the biomedical sciences and medicine; Public health claims to have an alternative, often more usefiil way of dealing with health and sickness than medicine possesses. It is this competition with medicine and the strong position of medicine in all major institutions which has inhibited a broader acceptance of the kind of research done by public health scientists and practitioners Finally, it can be demonstrated that those institutions and actors which are active in ameliorating the deficiencies in clinical and biomedical research do not have similar interests or strategies concerning the development of public health research. One of the most significant factors why public health has remained a somewhat loosely bundled agglomeration of approaches is the close affinity of public health research interests with political interests. Health ministries in particular have long been instrumentalizing public health researchers at will without at the same time providing for the establishment of a sounder and more continuous research base at universities. Funding agencies, in addition, have often neglected this side of health research. Political ftinding of research itself is, therefore, in this case one of the causal factors for the deficiencies in public health research.

7.1 THE INTERDISCIPLINARY

CHARACTER OF PUBLIC HEALTH

One of the major problems of public health research is that it can only rarely be carried out within one disciplinary subfield; instead, it is almost always dependent upon the interdisciplinary interlinking of different basic-science disciplines within the framework of a specific, application-related question. Public health differs from other interdisciplinary fields in the especially large number of basic disciplines that its research draws upon and in the differences in scientific tradition represented by these basic disciplines (for detail, see Braun 1993a, Vol. 1).

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Public health has to integrate at least three or four such foundations: a microbiological tradition, which provides knowledge about the somatogenic conditions of infectious disease based on the paradigm of natural sciences; an epidemiological-biostatistical tradition, which processes, prepares, and assesses data on the occurrence, diffusion, and course of disease among the general public; and a social-scientific tradition, which seeks to explain the social, political, and economic actions of individuals and institutions. Medical disciplines also play a substantial role in public health: both medicine and public health focus their research on health; part of the knowledge won in public health sciences, especially in epidemiology and biostatistics, is also of use to medicine; and conversely, these sciences require the knowledge gained by physicians in order to be able to estimate such influences as that of environmental factors on the individual. "Medicine and public health are intimately related, often overlapping..." (Fee 1987: 2). The effort to interlink the social and behavioral sciences with natural-science-based disciplines such as biology and medicine leads to constant problems. Even in the United States the gap separating these two different scientific traditions could not be bridged (Schwartz and Badura 1990: 7). The fragmentation turns out to be even greater when one considers that the social sciences themselves are a collection of several, often mutually contradictory paradigms. For this reason, public health as taught and researched at medical and non-medical schools is often little more than the organizational coexistence of a series of disciplines from different scientific traditions, each leading an organizational life of its own. Accordingly, I find it fair to characterize scholarship in public health in the following way: it represents an agglomeration of a diverse set of scientific traditions with a common focus, rather than a unified scientific discipline. The development of a unified scientific community with a common approach to research has been impeded up until now at least in part by the inclination of scientists to base their research activities on one of the three or four foundations of public health. This is not only the natural result of the socialization that these scientists have undergone during the early part of their professional training. It also results from the fact that the credibility cycles of researchers have remained tied to individual disciplines. Reward systems in science are almost exclusively based on disciplinary rules and specialized scientific communities. Thus, interdisciplinary research generally

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suffers from an inherent tendency to break down into its original parts. The social mechanisms of science have a centrifugal effect. There are also other reasons why interdisciplinary research is unattractive for scientists. This includes the high time costs connected to this kind of research (the high interaction costs between scientists from different disciplines) and the information and communication barriers caused by the different lingual styles and scientific jargon cultivated in each discipline (see also Kocka [ed.] 1987). These are factors that generally obstruct interdisciplinary research. In our case, the problem is aggravated even further by the low status of public health among the natural sciences. Both a low degree of attractiveness and centrifugal tendencies prevent the establishment of a coherent scientific discipline. Different approaches continue to coexist within universities, a situation only occasionally interrupted by brief spurts of common research activity. The consequence is the inability of public health to present itself as a coherent and unified force within the academic world and within the environment of the scientific system. The highly dispersed scientific foundations of public health, the centrifiigal forces inherent to the organization of science along disciplinary lines, and the low degree of attractiveness of interdisciplinary public health research are impediments for the development of a more coherent and unifying research tradition. Even though they share these tendencies that inhibit the development of a sound scientific base, the institutional differences between the United States and European countries have resulted in differences in performance in public health research. There is a significantly higher degree of productivity and cooperative efforts in the United States than in Europe. This can be attributed to institutional opportunities given in the United States. The United States has the advantage over Europe of possessing large departments, which give public health scientists the opportunity to alternately work together with several different groups of subfield specialists. The traditionally heterogeneous department structure and the dean-based department model also make it easier to establish professorships in new disciplines, which can then spearhead different interdisciplinary teams. These arrangements allow institutions to respond more flexibly to changes in scientific development. The existence of university-based schools of public health, rarely found in Europe, is a necessary prerequisite for improving the productivity and

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innovativeness of research and establishing a link between science and practice. The physical proximity of these schools to other disciplines on the university campus and the flexibility of university structures in adopting interdisciplinary arrangements are advantages which can be made use of in the United States in order to lay the foundation for an interdisciplinary research structure in public health. In contrast, the small sections within medical departments or the isolated institutes found at European universities do not provide the institutional prerequisites for such flexible cooperation between different basic-science disciplines under the common denominator of general-population-related health research. Nevertheless, even in the United States these structural opportunities were not sufficient for overcoming the centrifugal forces in interdisciplinary public health research. As a consequence. Congress has now agreed to establish a few Centers for Health Promotion and Disease Prevention which are intended to generate the same positive effects for long-term interdisciplinary research in public health as they have in clinical research. The first evaluations of these centers have been positive, on account of their research performance and of their success in the transfer of public health knowledge into areas of practical application. But it took until the end of the 1980s before such a measure, which had long been established in clinical research, was implemented. This is just one example of the generally lower degree of attention that funding agencies and the government pay to public health research.

7.2 THE COMPETITION BETWEEN MEDICINE AND PUBLIC HEALTH

A further obstacle that has limited the emergence of public health as a strong and independent discipline has been its conflict with medical schools, and more generally, with medicine itself. Public health and medicine do not stand in a relationship of equality. Whatever opinion one may hold of their relative social importance and moral legitimacy, there can be little doubt that clinical medicine is the more wealthy and powerful of the two. Where the two enterprises directly compete for resources, medicine usually has the advantage. As the weaker partner in an uneasy marriage, public health strives for autonomy and

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independence from medicine, while at the same time desiring the stronger partner*s status and protection. The two are irrevocably linked, unable either to merge or become completely independent. (Fee 1987: 2)

The stronger position of medicine - one could even speak of the hegemony of medicine - is of a structural nature. Three reasons can be given as to why medicine is systematically favored: • Medical intervention is held in higher esteem than public health measures because of the immediacy and visibility of this intervention. The patient who seeks out a physician expects immediate help to ease his or her suffering. By contrast, public health measures are usually long-term projects. Individuals are inclined, however, to give greater value to events in the present or near future than to those in the more distant future. The occurrence of ftiture events is simply uncertain. Everyone is prepared to see a doctor immediately if he or she is in pain. But the individual generally resists taking preventive measures that reduce the probability of fiiture pain. As Luhmann (1990: 190) has noted, individuals behave quite rationally in this regard: it is less costly to wait for harm to one's health than to invest in preventive measures presumed to be unnecessary. • The physician is the person who attends to the patient at his or her time of illness. His or her role is clearly recognizable and visible to the patient. It is easy to connect the alleviation of pain with the physician's intervention. Cure induces gratitude on the part of the patient and contributes to the high esteem in which the medical profession is generally held. Quite the opposite with the measures taken by public health officials: their results are often uncertain, they often cannot even be identified as interventions, and they are frequently not even visible at all. Subsequently, public health finds it much more difficult than medicine to gain the public support it needs. • Medicine's visibility and immediacy do more than just strengthen its public status. They also contribute to the institutionalization of the curative and individually oriented paradigm in national health-care systems. The point of reference of the health-care system is certainly not "to avoid disease" or "to promote health"; rather, it is to heal the patient (see Luhmann 1983; 1990). And this is also the aim of the most important institutions in health-care systems, such as hospitals, private

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practices, and health-insurance funds. By contrast, public health did not have the privilege of shaping many of the organizational structures of the health-care system in the service of disease prevention. Thus, the way the health-care system is institutionalized only serves to foster the curative approach of medicine and neglect the preventive tradition of public health. The position of public health in society is ftirther weakened by another difference between it and medicine: By curing patients, a physician does not contribute to the elimination of disease as such. He or she is thus assured of new patients and the continuation of his or her practice. Public health officials are faced by a very different situation: the success of public health measures can in fact lead to the end of their activities. One need only recall the highly effective intervention of public health specialists in the struggle against infectious diseases. By the start of the postwar era, most problems in this field had been solved. And this triggered a crisis in public-health research. There were, namely, hardly any other problem areas in the Western industrialized countries of that time requiring intervention. Hence, in terms of his or her credibility cycle, success always harbors a danger for the public-health scientist: it might jeopardize his or her continued public and political support. The situation, however, is even worse if public health proves unable to demonstrate success. The competing paradigm of medicine could only profit from this. Thus, whatever the public health official or scientist is capable of achieving, his or her credibility cycle is jeopardized. These factors may explain why medicine has succeeded in attracting more financial and institutional resources and more public funding than public health. Considering these factors, it is easy to understand why public health has so frequently been subordinated to the curative orientation of medicine, and why sustained tensions exist between the two approaches. They are not incompatible, but they do compete for the same scarce societal resources. Can it be contended that there is a difference in the development of public health as a scientific discipline if it is institutionally separated from medical schools as it is in the United States or if it is incorporated within medical departments as is often the case in the European countries? The answer is: there are differences though they are not as great as one might expect:

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It is contended by most experts interviewed that in the European countries the frequently small institutes or departments that take up aspects of population-oriented medicine were hardly able to win out against the powerful clinical disciplines in questions of allocation. There are also practically no opportunities for institutional expansion. On the contrary, today, in times of scarce resources, it becomes ever more difficult to obtain sufficient resources as competition intensifies. The conclusion reached in regard to allocation problems in clinical research can be repeated once again: whatever is of direct utility for patients is always given higher priority in allocation decisions made within university medical departments. Moreover, it is difficult to defend public health research from being exploited intellectually for the purposes of curative medicine. The survival of public health, once incorporated into such departments, demands an adjustment in cognitive orientation. There are only two conditions (cited by English experts) that make it possible to partly avoid being defined by medicine in this way. If a public health department within the overall university medical department is large and if it is at the same time capable of consistently acquiring a high percentage of grants, a certain degree of independence could be gained within the resource-allocation process of the medical department. This would allow public health to develop in its own way. In the United States 8 private and 16 publicly financed, public health schools separated from medical schools trained about 11,000 graduate students in 1988 and had combined faculty staffs of about 2,400 investigator-teachers. Especially at the eight private schools, which are quite dependent on outside funding, research is the predominant orientation (about 60% of time resources are devoted to research according to a spokesperson of the Association of Schools of Public Health; ASPH). Schools of public health were frequently established independently of medical schools, but on the same university campus. Their organizational autonomy has had both advantages and disadvantages. On the one hand, it has allowed them to avoid being subordinated to the traditionally stronger clinical disciplines and has made it easier for them to pursue the diverging interests of public health research. This kind of institutionalization has allowed for a more independent development than in Europe and certainly explains the high productivity in public health research in the United States. The problem is the dirth of links and coordination between clinical

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knowledge and public health knowledge. Because of institutional separation, there is a constant risk that cognitive advances made in the clinical disciplines might not be registered in their public health counterparts. Since clinical knowledge might be crucial for certain areas of public health, its absence could jeopardize the quality of research. The proximity to medical schools still made collaboration possible - an even worse option would be the establishment of public health research outside the university - nevertheless, it has been difficult to organize cooperative efforts. This implies that the European construct, by allowing for direct and personal links between medical and public health scientists, is superior in the communication opportunities it offers. It is inferior in that it places public health in imminent danger of being subordinated to the interests of medicine.

7,3

THE ROLE OF POLITICAL RESEARCH FUNDING

In all the countries analyzed, a peculiar pattern of dual ftmding of public health research can be observed. On the one hand, political authorities possess a marked interest in results from public health research. Funding for such expedient research is provided by the government health ministries of the various countries. On the other hand, the more basic-science-oriented ftmding proposals in the field of public health are usually referred on to the funding organizations. This poses the following dilemma for public health research: in the first funding context, it can receive grants for individual research areas from departments within various health ministries. Here, relatively small sums are involved, and the type offtmdingcontributes more to the differentiation than to the integration of public health research. Conversely, in the second funding context, public health is drawn into grant competition with biomedical and clinical research and has few prospects of emancipating itself from the constraints this entails. Let us turn now in greater detail to these two kinds of ftmding and their implications for public health research.

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7.3.1 The Funding of Public Health Research by Health Ministries

The reference point of public health - the optimization of the general health of the population - links it to political interests. The development of public health sciences has long been marked by their direct proximity to politics and the concomitant problem of fields of study guided by criteria of utility originating outside of science; this has had a negative effect on their image within the scientific community. It is always more difficult for a policy- and application-oriented science to secure a recognized and independent status as an academic discipline than it is for a science that is detached from all user systems. The utility of the knowledge accumulated by public health fosters a completely positive attitude of the responsible government authorities toward it. Public health is regarded as a helpful instrument in designing political strategies for the future and for implementing health-related measures. However, precisely this usefulness leads political actors to attempt to instrumentalize public health. It does not, however, move them to promote its general place in society or bolster its position as a science in the university. The results resemble those of the above-cited case of the hegemony of medicine: Public health research receives funding, even if it is negligible in comparison with that of medicine. However, these funds are not intended to create fields of research which might be important for basic research and the development of a common and unifying paradigm. They are meant to produce useful knowledge for the political subsystem and the health care subsystem. In other words, politics views public health sciences largely as a service sector. Political interest is short term in character. The part played by public health research in politics is linked to present problems, which hopefully can be solved by applying knowledge derived from this field. The politician loses interest in supporting public health research once the problem is solved or other problems arise that absorb his or her interest. This issue-attention cycle leaves little room, in either of its two phases, for establishing a sound scientific foundation for public health by means of basic research: In periods when public health can contribute to a current issue, the call in the political arena is for applied science. In periods when a public health issue does not

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capture the attention of politics, resources are not made available. The sporadic and temporarily limited character of political funding stands in contradiction to the long-term time frame characterizing basic-science-oriented research that would be required in public health research in order to overcome the exploratory stage of cognitive development it finds itself in. The integration of topics from outside of science can certainly have innovatory effects on a scientific discipline; however, no paradigmatic development can be initiated if extrinsic needs are the sole sources of research topics. The usefulness of public health in policy-making decisions and even the success of its past measures have not won, however, public health research esteem comparable to that given to biomedical research by politicians and sponsors. As a consequence, public health research is often underfunded. The "biomedical lobby" enjoys two advantages over those representing public health research: First of all, the kind of research done in biomedical sciences is measurable and cumulative. More importantly, though, a discovery made in biomedical research has visibly positive effects in the struggle against a specific disease. The visibility of the work and achievements of biomedical research and the immediate applicability of the results of its research represent important criteria for politicians in their decisions whether to allocate funds. I would like to give a brief illustration of this difference between public health and biomedicine. If, for example, the genome responsible for a certain disease is found, this immediately contributes to reducing the incidence of that ailment. On the other hand, a public health scientist who tries to demonstrate that smoking causes lung cancer by long-term intervention studies may find his or her assumptions confirmed. However, it is a long road from the knowledge of risk factors to the actual elimination of environmental and behavioral factors influencing lung cancer. What he or she is doing, may, in the long run, become visible to the general public. In the short run, though, it is usually neither measurable nor visible. The dilemma of public health representatives lobbying for more support from members of Congress was put in succinct terms by one U.S. interview partner: "You cannot tell the Congressman that what you are doing at the moment may have some effects on the health of the population in perhaps 20 years. He won't understand. Moreover, most of the Congressmen don't even know what public health is." Thus, public health is at a systematic

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disadvantage: it simply cannot make its research findings as visible as medicine can. The instrumental way in which public health research is funded appears to be marked by the following features in all the countries analyzed: the small size of grants that can be provided by the ministries for health, the degree of fragmentation in the formulation of the needs of research within the ministries, and the problematic coordination between the application-oriented needs of the ministries and the scientifically oriented policy of the funding organizations. The French health ministry has only taken on marginal responsibilities for research funding up until now. On the one hand, this is because it hardly has any money for such purposes; on the other, it is due to the fact that the research ministry and the mission agencies conduct most research and funding activities. Furthermore, for a long time, the French political system was neither interested nor able to promote public health research. The jurisdiction for different aspects of public health was fragmented among a number of departments of the Ministry of Health. Moreover, research represented a low-level priority within this ministry. French political authorities seemed to be content just to train a few health administrators at the National School for Public Health in Rennes. The few research projects commissioned by the individual departments of the health ministry are not coordinated with each other. The contacts between INSERM and the health ministry remained for a long time at a fairly low level in spite of the ministry's seat and voting rights on the administrative council of INSERM. There was hardly any coordination of funding plans. Only in the wake of the AIDS issue and through the efforts of INSERM have contacts recently been intensified. In general, the overall attitude of the government concerning public health began to change with the growing problem of AIDS. After an unsuccessful period of funding from 1986 until 1988, the Prime Minister launched a major institutional reform. The failure of both INSERM and CNRS to give adequate attention to the public health aspects of health research led to the government's decision to create new organizational structures. (This was only after the government's attempt to put INSERM in charge of accelerating advances in French AIDS research resulted in INSERM largely devoting its energies to basic biomedical research). The Ministry of Health lost its jurisdiction over education and funding in the field of AIDS, and these were turned over to the Agence Nationale de Lutte contre le SIDA. INSERM was

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compelled to accept a relatively independent organizational unit within its own organization, the Agence Nationale de Recherche sur le SID A (ANRS), whose mission is to take up all subfields of AIDS research (i.e., its immunological, clinical, and public health aspects). However, INSERM has remained the institution which receives AIDS-earmarked appropriations and then passes them on to ANRS. In the meantime, considerable sums have been earmarked for and expended on AIDS research. ANRS initiated the first collaboration in France between scientists and politicians and between clinicians, basic researchers, and social scientists in public health. Public health research is increasingly attracting the attention of the young, and the new projects initiated in this field might gradually provide for the critical mass of public health researchers necessary. As in all other countries, AIDS has presented public health with a welcome opportunity to improve its status in society in general, and among those active in politics and academia in particular. It is nonetheless obvious that public health research is still dependent on the issue-attention cycle in politics and is still faced by hostility within the biomedically minded INSERM. Given the predominance of biomedical scientists, it is unlikely that INSERM or other government sponsors of research will continue to support public health research at today's levels once the problem of AIDS loses some of its public impact. Presently, however, the high degree of attention granted aspects of public health by politics continues to motivate new institutional activities in the political sector. The former Socialist Minister of Health has begun to lay the foundation for a new public health center, which is to be named Centre de Santi and which is comparable to the Center for Disease Control in the United States. This measure convinced the Minister of Research of the necessity of also becoming active. An expert at Codis was requested to develop strategies for providing public health with a more permanent and fruitftil basis. Since universities are out of the question in this regard, the general inclination is toward the creation of a center of excellence comparable to the Maison de I 'Homme et de la Sociite, the most important French research center in the social sciences. The Maison is designed as a foundation and is largely dependent on the financial support of the state. It nevertheless has the clear advantage of being relatively free from outside interference in the management of its daily affairs and in the formulation of its research policy. Moreover, such a center would also have the advantage

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of being a clear and visible location for all actors involved in aspects of public health. In the United States, where the Department of Health and Human Services (DHHS) administers the entire field of health and thus integrates the research funding of public health and medicine, the funding of public health research is distributed across a whole series of different agencies (such as the Centers for Disease Control, the National Center of Health Statistics, the Environmental Protection Agency, and the Agency for Health Care Policy and Research [AHCP]). The funds available to these agencies are in no way comparable to those of NIH. Whereas epidemiological research possesses a relatively high status within government agencies, the promotion of social-science-oriented research remained underdeveloped for a long time. This had negative effects on the administrative hierarchy. The agency responsible for this research (the National Centers for Health Services Research and Health Care Technology Assessment) had a lower administrative status than NIH for a long time. Only with the founding of the AHCP in 1989 was public health research upgraded and the agency given administrative status equal to that of NIH. Its funding continues to be much lower.^ However, this granting of equal status does allow the AHCP to come to terms with NIH from a position of equality and makes it possible for the two organizations to coordinate their funding policies. Moreover, public health research is not as strongly instrumentalized by the government agencies of the DHHS as it is in the health ministries of other countries, since, for example, the AHCP is a funding organization in keeping with the model of NIH, and thus as a mission agency is also interested in the basic-science-oriented development of public health. Much less U.S. funding is directed to public health than to biomedical research. This is not only witnessed by the low budgets of CDC and AHCP in comparison to NIH, it is also reflected in the level of federal expenditures for the schools of public health: these 24 schools received ca. $140 million in research grants in 1987/1988 (about $7.8 million per facility), $17 million in training grants, and $12 million in student aid (Spring and Magee 1989: 67). These schools' overall expenditures reached $430 million in 1987/1988

80 In 1990, the agency had about $100 million at its disposal.

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(ibid.: 68). As a point of comparison: the 127 medical schools received $2.9 billion in federal support in 1987/1988 (see AAMC 1989: 9), which amounts to about $23 million per medical school. In England, the Department of Health and Social Security (DHSS), today the Department of Health (DoH), commissions research in public health. There are four different ways in which the DoH can be active in the field of public health: (1) It is responsible for the National Health Service (NHS) and regularly provides the latter with a specific sum of money for the funding of research on the health care subsystem, aimed at increasing its efficiency. (2) The External Boards provide the DoH with a kind of instrument of governmental research which it can use, for example in the area of infectious disease, to retrieve important epidemiological data. (3) In 1972, key substantive priority areas were designed for the department, and they were accompanied by so-called Research Liaison Groups, Precisely in this area, the fragmentation of administrative interests created considerable problems for the flexible adjustment to new problems and for the coordination of research policy. Areas of vested interest emerged, which could not be coordinated (see Klein 1985). The actors in these areas, often scientists themselves or representatives from health care agencies, funded those subfields of public health research that appeared to promise them the most useftil results for their own activities. The fragmented funding of public health research by the DoH thus contributed to a dissociating development in public health in England. (4) And finally, health-related measures can also be taken by means of the MRC. There were long struggles between the^PoH and the MRC over which rights the former had to introduce its own conceptions and priorities into the MRC. England is also the best example of the dynamics that can produce incompatibility between the self-interests of the ministries and basic-science-oriented development of public health. A remarkable point is that since the 1970s the DoH deliberately attempted to reconcile the two sides of public health research within its own funding, whereas the other countries sought to differentiate organizationally between application-oriented and basic-science-oriented research.

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The DoH sought to develop its own researcher potential in certain areas of health research within universities by awarding public health research groups short or medium-term grants. It was clear to the DoH from the very beginning that it would be difficult to find suitable researchers for the kind of research envisioned. The heavy application-based requirements, the frequent multidisciplinarity of the research projects, and the lack of potential gain in reputation associated with participation were all expected to create complications. Researchers were needed who were willing to tie their fates to that of politics. As a consequence, the strategy adopted was to build up a scientific potential at universities which could be used when needed. Researchers participating in such government-financed research groups usually came from disciplines with a low status or a less established position in the scientific community. Scientists active in such disciplines hoped that cooperation with politics would bring financial security and an opportunity for scientific development in this way.^^ In such a cooperative relationship, it can be contended, that the political side is basically the stronger of the two parties involved. Its stronger position arises from the fact that DoH funding makes the public health scientists increasingly dependent on the support of politics,^ but DoH is able to dismiss these scientists anytime it so desires. However, the option of dismissal was long more theoretical than practical. On the one hand, politics depends on science to provide it with information to aid in policy formulation. On the other hand, as was mentioned above, special-interest alliances arose that made it difficult for politics to make a principled about-face in its stance toward science. Such an

81 Kogan and Henkel also discuss this point (Kogan and Henkel 1983: 166). They distinguish between strong scientific disciplines, which have little inclination to cooperate with govemment departments and weak disciplines, which hope to gain advantages by taking part in such ventures. They cite the MRC, as the representative of basic biomedical research, as an example of the former: it has successfully persevered in resisting "encroachment" on the part of the DoH. 82 The dependence increases because the added revenues of DoH funding allow the scientists to appoint additional personnel and to expand without gaining any institutional security because the funding remains contingent on the provision of certain services.

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about-face was attempted in 1986 without much success. Recently, the DoH has made a shift toward more intensively commissioning commercial facilities rather than university institutions to carry out its health research projects. The scientists who take part in DoH-funded projects basically have no exit options. There are hardly any other ftmding sources for the kind of research that they perform. Thus, in a certain sense, scientists and politicians are still unified by a converging interest. DoH research units - ftmded by 6-year rolling contracts - became an important basic component of research.^^ The critical problem with the effort to establish a scientific community in public health by means of this ministerial ftinding was that the formation of research units remained dependent on an internally fragmented and shifting political interest.^^ This provided no basis for developing an autonomous research tradition. This was joined by the fact that dependency on politically motivated financing made it difficult for these research units to gain acceptance from scientific institutions. Though most DoH research units were located at a university, they found themselves subject to a dual credibility cycle: in order to solidify their position at the university, they were required to contribute to the search for truth according to the criteria of the scientific subsystem, while at the same time the utility (exploitability) of their research was being assessed by the DoH. The result was that the academic disciplines that would have been useful for the DoH and that were supposed to gain an autonomous, academic reputation by being established did not in fact develop to the extent hoped for.

83 They are reviewed every 2 years, but after 6 years a basic decision is made whether the quality of the research team is satisfactory and whether the department involved is still interested in the research findings produced by this unit (O'Grady 1990: 3). 84 Many research units "were established to meet contemporary needs in perhaps more expansive times, and many have subsequently been disbanded. As a result, the present stock is very mixed in size, subject area, degree of specialization—and extent to which they meet the Department's present needs" (O'Grady 1988: 3).

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Despite the academic context, and the need to maintain and enhance their standing in their disciplines, the units do not enjoy the freedom of action that their locations might imply. In return for a secure environment in which to develop and expand their interests, units are expected to act as a store of expertise which the Department can draw on in its policy development. When these needs conflict with the units* own perceptions of the most appropriate future development of their work, tensions of course arise in the arrangement, which calls for exceptional degrees of mutual understanding and trust. The most successful units show that this is possible (O'Grady 1990: 3-4).

One of the reasons why agreement could no longer be reached on the "definition of objectives" is precisely the tendency of research units integrated into the university and financed by the DoH to place their focus on the point of reference of science, as a means of becoming part of the academic canon. However, when this happens, politics no longer has access to its research units. Theoretically, politics has three options for establishing a high-quality core of researchers. All three prove ultimately not to be stable enough to bear the pressures created by the basic relations of tension between scientific curiosity and political self-interests in public health research: (1) First of all, political authorities can commission government departmental research facilities with public health research, seeking here to attract highly qualified scientists and to equip these facilities as well as possible. However, the DoH in England does not have this option; moreover, the example of Germany shows that such government facilities are also unable to overcome the conflict of the scientist caught between service-oriented research of little reputational value, on the one hand, and the desire to do basic research with great reputational value, on the other (for a comprehensive account, see Braun and Schimank 1992). (2) Secondly, it can assign the task of establishing public health research to an independent ftinding agency, such as was done with the MRC in the case of medical research. Interestingly enough, this was exactly the conclusion that the House of Lords Select Committee, authorized to evaluate the state of affairs in health research (Select Committee 1988). reached on the existing deficits in the English realm of research. The Committee noted that the Research Councils, and especially the MRC, were not capable - and this was not actually their aim - of establishing a research community in the public health area. And that both the NHS and the DoH were too concerned

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with their own self-interests (patient care and policy consultation, respectively) in order to allow high-quality public health research to be established. In the opinion of the Select Committee, public health research needs to be institutionalized on its own, and this should occur as far as possible from the competition of biomedical research (MRC) and political self-interests (DoH). The recommendation was made to found a National Health Research Authority (NHRA), located within the National Health Service, but institutionally separated from the DoH. The aim was to have the NHRA meet exactly those shortcomings still displayed by the previous system, i.e., determine the research needs of the NHS, develop in conjunction with the MRC an appropriate research funding program in response, and take on commissioned research for the NHS.^^ In order to establish public health research, the NHRA was supposed to found at least three public health centers at medical schools. The amount of money that went into the public health area would have to be raised considerably in the view of the Committee (Select Committee 1988, 1:33). Emphasis was placed on the necessity of establishing systematic public health research (ibid.). In fact however, this institution was never founded. Even though the DoH cannot negate the recommendations of such a high authority as that of the House of Lords Select Committee, the decision was made not to accept the recommendations in this form.^^ Above all else, the DoH was unwilling to give up control in questions of public health research. Instead, an organizational reform was designed in which the DoH received all directive powers, but also all future responsibility for the public health research of the NHS and the DoH. On 1 January 1991, the position of Director of Research and Development was established; in contrast to the preceding Chief

85 In addition, there were a series of other tasks such as the dissemination of research findings and the evaluation of clinical studies and new technologies (see Select Committee 1988, Vol. 1:32). 86 "The Government accepts the principal thrust of the recommendations that a new initiative is required to help the NHS identify and meet its own research needs. But it rejects the Select Committee's proposed solution of a 'National Health Research Authority'" (DoH 1989: 1).

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Scientist, it represented a ftill-time position, and its holder did not merely attend to the development of DoH research funding, he or she was also responsible for the development of NHS research fimding.^^ This position was also given a higher status within the ministerial bureaucracy. However, it still remains questionable whether this reform will suffice to eliminate the basic tension between science and politics in the field of public health research. (3) Thirdly, politics can attempt-as DoH has done for many years-to establish a basis for research with its own funding grants, which it can always have recourse to. Here it must face tendencies toward autonomization on the part of research facilities (induced by the logic of the scientific system). For this reason, the DoH has now distanced itself from the idea of establishing for itself a scientific and easily acquirable foundation for research. Moreover, in periods of scarce resources, one is always more cautious in taking on long-term commitments, since this adversely affects an organization's flexibility (which is especially necessary in such times). The utilitarian policy of the Thatcher government has sensitized the ministries to the importance of insisting on the provision of concrete services in ever shorter periods of time. The DoH has now shifted to commissioning commercial research facilities, instead of research units, to do short-term research; the former, namely, are able to work "quick and dirty." Does this show that the experiment of committed political ftmding in the public health field has failed? At the very least, it can be claimed that the relationship between application-oriented political research funding and

87 The following new tasks were cited: "Advising the NHS Management Executive on priorities for National Health Service research and managing a programme of NHS research to meet identified needs, particularly research into the efficiency and effectiveness of health services; supporting the creation in the NHS of regional and local arrangements for identifying and meeting clinical and service research needs; monitoring the service support and facilities provided by the NHS for externally funded research; ensuring that research information is widely disseminated..." (DoH 1989: 1).

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scientific development is marked by a basic tension that is practically irresolvable. Above all, it makes clear that longer-term funding, expressly targeted to the creation of an academic home for the disciplines of public health that will then provide politics with practical knowledge, is condemned to failure. In Germany, the fragmentation of departments dealing with aspects of public health research at the Ministry of Health resembles that of the French Ministry of Health. These departments occasionally fiind public health research on a minor scale, when this research lends itself to the improvement of knowledge useful for political action. This funding does not in any way intent to contribute to the formation of a more coherent and durable scientific community in public health. As does the British Department of Health, the German ministry supervises governmental research organizations involved in drug testing, virological research, and epidemiological studies. The point here is that these research organizations are heavily involved in day-to-day assignments for the government without having time to establish independent and basic research. Most qualified scientists who are trying to maintain their reputation within the scientific system stay only temporarily within these institutions. Once again, the money invested in the governmental research organizations cannot be used to create a sound foundation for public health research (see in detail Braun 1993a, Vol. 1). Finally, the Ministry of Health participates within the Federal Program on Health Research administered by the BMFT. There is some coordination concerning research topics but, in general, the BMFT is the leading agency for the implementation of health research. It is because the BMFT, as the research ministry, is responsible for the promotion of health research, that the promotion of a scientific foundation for public health research can become part of the Federal Program. The BMFT does not have any short-term interests in the results of public health research, but regards it as one of its chief aims to establish institutional conditions for the transfer of basic knowledge from all fields of health research into areas of application within the health care subsystem. The promotion of cognitive advance in public health has been integrated into the Federal Program since its beginning. The main thrust of activities, though, has long been restricted to the establishment of a major study on risk factors in cardiovascular diseases. Only in the last few years have the pressing problems triggered by AIDS sparked a new awareness of the necessity of

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building up a more coherent and productive scientific force in public health. Since then, a number of public health centers at universities have been funded which, after a certain period of time, will become integrated into the appropriations for the basic-facility funding of universities. In this way, it is hoped, structural core units for the establishment of public health research will arise.

7.3.2 The Funding Funding-Agencies

of

Public

Health

Research

by

the

Public health - in contrast to biomedical research - has found little support among those funding agencies that regularly fiind health research. The views of the experts I have interviewed suggest that when public health and biomedical research have to compete for the same resources within the funding agencies, public health research is always a second- or third-rate priority of these organizations. This has first of all to do with the traditional way in which these ftinding agencies conceive of their mission: The institutes of NIH were established to combat very definite areas of disease. At best, aspects of public health were allowed to play a post-facto role. Though INSERM arose as the successor organization to the government's institute of hygiene, from the very outset it defined its area of responsibility as that of clinical research, devoting itself primarily to basic research in biomedicine. CNRS has never regarded itself as involved in public health research. The MRC was certainly established with a general-population-related goal in disease control, namely, to fight against tuberculosis. However, when the English health department was founded, there was a clear demarcation of responsibilities, distinguishing between biomedical tasks on the one hand and population-related measures on the other. Only the project-grant agencies of the BMFT were obliged from the very beginning of the Federal Program in 1988 to take account of developments in public health. As it turned out, disease-related ftinding increasingly replaced public health research in the Federal Program. The DFG with its corporate identity as a funding institution for the basic sciences has only reluctantly approached public health during the last few years.

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Thus, the underprivileged status of public health in the funding agencies of the four countries was completely in keeping with the charters of these organizations. It was only the increase in degenerative chronic illness that brought greater focus on questions of life-style and environment. In addition, AIDS prompted political authorities to have funding organizations intensify their funding policy in public health research. Everywhere, much greater resources were made available for this purpose. However, the interest of sponsors in basic research in biomedicine was so established that it was almost impossible to have public health funding increased. For example, public health research had difficulties just being recognized as a science of equal status among the scientific review boards of funding agencies. Moreover, sponsors are primarily success-oriented. Molecular biology - with its relatively unified and rapidly spreading paradigm - seemed to promise much greater prospects of success for any scientific grant than did a public health research project still caught up in an exploratory phase of scientific development (and thus representing a research funding object of much greater risk). Another great advantage that biomedical research with a molecular-biology orientation has is the clear visibility of its research successes. Such visibility makes it easy for those promoting research to demonstrate the effectiveness of funding to the creditor. In this context, public health research is at great disadvantage. Its research is so long term in scope that proof of success could take ten or more years. And even providing such proof represents a further weakness of public health: it is almost impossible to distinguish the causative factors behind the changes that a public health intervention seeks to induce. In other words, whether the intervention actually caused a change in a health indicator or in the conduct of the general public is almost impossible to prove, given the inability to hold factors constant. For these reasons, it is easy to understand why there is no intrinsic incentive for a sponsor to provide funding for public health, and why special measures are needed to make such funding projects "presentable." The question thus arises: what has been done on behalf of public health research in the funding organizations? In establishing the funding organizations as so-called EPST {etablissements publiques scientiflques et technologiques), the socialist government in 1982 in France made the valorisation sociale, the

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commitment to a social orientation, part of the statutes of the INSERM and the CNRS. This implicitly referred to a funding policy oriented toward the health care subsystem. By the end of the 1980s, INSERM's expenditures on epidemiological and public health activities made up 8% of its budget. Furthermore, 8.3% of all researchers were active in such research fields. However, 70% of the units conduct research solely in the epidemiological field, and only 30% have a social-scientific orientation. In the view of the government, though, these efforts were, as is described above, insufficient for providing suitable research activities in the field of AIDS. The grands organismes were officially accused of having failed to discharge their responsibilities in funding and research policy in the health sciences, and INSERM had to accept a new agency within its confines dealing relatively independently with AIDS research. The relatively marginal efforts by INSERM in the public health field, the one-sided orientation toward epidemiology, and the organizational inflexibility that became apparent in AIDS research funding are exemplary demonstrations of the resistance brought forth by actors from the biomedical lobby within INSERM. At the beginning of the 1980s, Congress demanded more commitment to public health research from NIH in the United States. Since then, 3% of its budget, or approximately $230 million, has been officially expended in this area. Here, NIH focuses on aspects of public health that are directly related to biomedical or clinical research. The other aspects of public health are considered the responsibility of the other aforementioned agencies within the DHHS. In England, public health was first established at the MRC in the 1980s, by means of two agreements between the DoH and the MRC. Even though it remains financially underprivileged, an organizationally stable and relatively independently operating administrative entity has been created within the MRC, whose objective is to help establish a scientific community in the public health field. The MRC allocates the funds set aside for this purpose according to its own criteria, even though the DoH has a say in the matter. Annually, £3.3 million are used expressly for the purpose of establishing a scientific community; however, as in NIH, the focus is on areas that are closely tied to clinical research. On the other hand, the Economic and Social Research Council (ESRC) devotes its funding to the more social-scientific aspects of public health research. The ESRC has started initiatives in the health-related services and

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funding projects on the health-related behavior of the general population; here, the emphasis is on the establishment of public health centers. Its resources, though, are more limited than those of the MRC: it spends about £1 million on public health research per year. In Germany, the DFG never expressly focused on this application-oriented field; however, it did support it to a limited extent in projects overlapping with other disciplines. This rather reserved attitude of the DFG now appears to be giving way to greater interest, as exhibited by the forthcoming memorandum on health care subsystem research. The funding provided by the BMFT within the framework of the Federal Program has already been mentioned. It should be emphasized that in all the countries studied and in all their major funding organizations involved in promoting research in medicine and biomedicine the commitment to the funding of public health research was well below that of other funding activities. It was only in the 1980s that changes were initiated, and this took place largely under political aegis. However, this problem has now been generally recognized, and it is fair to hope that structural improvements in the condition of public health research will now occur.

7.4

CONCLUSIONS CONCERNING PUBLIC HEALTH

Today public health research commands greater attention from the general public and politics than ever before. Both political authorities and ftinding organizations have become sensitized to the necessity of eliminating conspicuous deficiencies in knowledge of health-related behavior, prevention, and health care subsystems by providing greater funding for research. In the United States, this added attention has resulted in the raised administrative status of the AHCP, which is responsible for social-scientific research in public health. Even though itsfinancialabilities are much more limited than those of the NIH, the improvement of its status is important in the strengthening of research funding in the public health area. The development of public health research as a scientific field in the United

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States is especially favored by the ability of the AHCP to undertake funding activities both intramurally and extramurally. In France, the increase in the political attention given to public health has led to the creation of new coordinating institutions, which, however, have only been established for a certain period of time. Moreover, the division between individual research projects commissioned by the health ministry and the basic research promoted within the program of INSERM has not been overcome. Nonetheless, INSERM has also become more sensitive to the general-population-related aspects of health research. As yet, the resistance of actors at INSERM has stopped this awareness from being translated into new funding projects. For this reason, another strategy is now being pursued in France, namely, to establish an independent institution for public health, a centra de la santi, with primary focus on the funding of basic-science-related public health research. In England, AIDS has also heightened awareness for public health issues. There has been greater linking of the interests of the DoH and the funding activities of the MRC. The DoH continues to fiind various health-related topics within its own department, but has largely desisted from basic-facility funding for university research teams. The analysis of the House of Lords Select Committee has not moved the DoH, as demanded, to create an independent authority for the funding of basic research; nevertheless, it has been decided to raise the administrative status of public health research, and a commitment has been made to better coordination of research funding in this area. A similar sensitivity to public health research topics has arisen in Germany. Both the BMFT within its Federal Program and the DFG have recognized the lack of a scientific base in public health. This has prompted the BMFT to intensify its measures, though expenditures are still clearly in favor of biomedical and clinical funding. Meanwhile, a few public health centers have been established at universities which could represent the structural core for a paradigmatic development in public health. One finds, therefore, that activities abound in all the countries investigated. The real question is, however, how long will the newly created institutions and good intentions last, when public and political attention once again turns away from the population-related aspects of health. Attention is always a scarce resource. The inherent tendencies shown above for funding agencies to favor biomedical research could mean that public health research cannot be maintained without lasting and intensive political support within

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these funding organizations. With the exception of the United States, it could then largely become dependent upon the utility-oriented funding of the various national health departments. And this support is too marginal, fragmented, and short term to serve as a basis for the establishment of public health within the academic canon. What can be learned from this description of the general trends and structures of public health research and its funding in the four countries investigated? As a basic rule, the following conclusion can be drawn: If public health is institutionalized outside of medical school control, this can improve the growth chances of public health research at the university - indeed, there is no other way to explain the discrepancies in the intensity and quality of research in this field existing between the United States and Europe. Nonetheless, this is neither absolutely necessary, nor can it solve all the problems of scientific development facing public health.^^ Moreover, integrating public health into the medical department need not necessarily create the problem that its subsequent development is determined by the interests and dictates of medicine. This can be avoided if sufficient funding resources allow a large department or departmental section to be established: in this way, public health can partly dissociate itself from the allocation process of the medical department. However, this option is subject to two conditions: funding organizations have to give adequate attention to public health research and sufficient grants have to be available. In fact, though, the resources available for public health research - in spite of the increased attention given it by funding organizations - have remained much smaller than those for other areas of health research and, given the present financial constraints on government budgets, tend to be diminishing in size. International comparison has shown that there are a whole series of restrictions aligned against successfully establishing public health research as part of the academic canon, and these need to be taken into account in any possible initiatives implemented by funding agencies and policy-makers:

88 Thus, it is precisely this organizational separation between medical schools and public health schools in the United States that has produced great problems in establishing a coordinated interlinkage of research with medical departments. Conversely, this problem could be prevented (though this is hardly automatic) by incorporating public health into university medical schools.

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The path to a coherent discipline of public health is beset by reward mechanisms working to the disadvantage of the interdisciplinary efforts of public health science; public health faces the unified opposition of medicine, which holds the most important positions of power both in the health care subsystem and in the universities; it enjoys little public support, since it is unable to present itself as a unified whole, and it has long been discriminated against by funding organizations and instead found itself dependent on political interests which has served to stabilize the factionalism existing within the field.

8.

CONCLUSIONS: THE FUNDING OF HEALTH RESEARCH

Our basic concern at the outset of the study was to find out what kind of obstacles reduce the productivity and innovativeness of health research positioned as it is at the intersection between basic research and areas of application in the health care subsystem. Given the challenges and dynamics of health research nowadays clinical research and public health research seem to be the most important research areas for the solution of many of the problems besetting the health of the people. The obstacles which were found to have negative repercussions on the development of these transfer fields in science (tendencies of differentiation and centrifugality due to cognitive developments and social mechanisms inhibiting interdisciplinary and cooperative research efforts) can only be eliminated - given the inherent conservatism built into the functioning of the scientific and health care subsystems - if a third player, namely politics, becomes involved. It was shown that the political system has institutionalized funding systems to address their energies to the guidance of scientific development. The major concern of the study was, therefore, to discover how funding agencies with the mission of promoting health research were able to deal with the challenges and obstacles to health research found in the four countries investigated. Though the problems of clinical research and public health research described in this study are taken from the field of health research, they point to features that sponsors will find anytime that research takes place at the point where the scientific subsystem and user subsystems, such as the economy or health care, intersect. In this sense, many of the points made in the analysis here concerning the social dynamics of research, the institutional variations, and the problem-solving capabilities of research funding can also be applied to other problematic fields of research funding and thus permit a generalizable estimation of the problem-solving capabilities of the funding instrument. How useful is the instrument of research funding in initiating the transfer of knowledge between the scientific system and the health care subsystem, between molecular biological knowledge and clinical application? What explains differences in problem-solving capabilities from country to country? The problem-solving capabilities of research funding are dependent upon the type of problem, the make-up of the area of intervention, the

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organizational opportunities for action available to sponsors for solving substantive problems, and finally, the make-up of the available instruments and the combination of instruments of the funding organizations. The international comparison of health research and its funding systems in the United States, France, England, and Germany has demonstrated that the basic problem of clinical research and public health research could be found everywhere: i.e., finding enough scientists and clinicians and research institutions that are willing to "invest" in research at the intersection of two subsystems. The explanation for this problem was looked for in the social closure mechanisms of the scientific and health care subsystems. The example of clinical research served to demonstrate that tendencies toward differentiation between the activities of research and healing and their accompanying mechanisms of social closure exist everywhere. These differentiation tendencies existed in the cognitive discrepancies, mutually excluding credibility cycles, organizational (dis)incentives, and a rising complexity in scientific development that results in the specialization of knowledge. Since clinical research cannot be carried out without knowledge acquired by actors in two different subsystems (the scientific and health care subsystems), guidance is required to bring about the interdisciplinary and intersystemic research needed. Research funding represents one such possibility for giving guidance to this process. The fact that it still makes sense to intervene in this way, in spite of the dynamics of increasing differentiation under today's conditions, is shown by the differences in clinical research performance between the United States and the European countries. These differences can be explained - as the macrosociological analyses of research subsystems made by Joseph Ben-David demonstrate - in terms of the institutional conditions of research. Dissociating tendencies, it was concluded, can at least be slowed down by an appropriate framework of institutional conditions. It became clear in the description of the United States that funding organizations can play a decisive role in the development and reproduction of institutional conditions favorable to clinical research. Why is that? The way research and funding is structured in the United States provides NIH with an advantage over funding organizations in Europe and increases the problem-solving capabilities of its research funding. The enormous ability of the scientific subsystem to organize itself \n the United States largely frees NIH from having to use its funding activities to

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initiate structural changes in health research. Whereas NIH can establish clinical research teams or clinical centers purely by means of an incentive mode of funding, its European counterparts are forced to carry out an active search process to find scientists and research institutions willing to participate. What are the structural characteristics of the institutional order of the American scientific subsystem upon which this great responsiveness to grant-based funding is based? One possible answer is that the responsiveness of the scientific subsystem to signals given by research sponsors is determined by the degree to which researchers are dependent upon grants. This would imply that the greater the grant dependency or the smaller the basic-facility funding of research institutions in a given country, the greater the scope of influence of research funding. Given the enormous importance of the "grants economy" for the development of health research in the United States, this could be a plausible indicator of the large scope of the formative powers of U.S. funding agencies in comparison to their European counterparts. The present study attempted to show, though, that the greater scope of influence of the funding measures of NIH (compared to that of European funding organizations) cannot be explained simply in terms of the greater dependency of American researchers on grants. Given the cutbacks in basic-facility funding in Europe starting in the eighties, there is hardly any difference anymore between American and European researchers in their responsiveness to grants, //"researchers want to do research. There is still ample room for scientists and above all clinicians in the European countries to abstain from research, if they prefer to do so. This opportunity is not available to those working at the research medical schools in the United States. The unique institutional feature of the United States, though, that explains the larger scope of influence of NIH is the fact that not only the researchers, but also the administration of research institutions developed great interest in such resources. It is the converging interest of the administrator and the scientist/clinician in research performance which has shaped the considerable responsiveness of the scientific subsystem to grant funding in the United States. For institutions to develop such interest in research funds, which is in no way automatic, a series of institutional conditions had to be fulfilled. Thus, it was clearly important that

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• The medical schools in the United States, in contrast to their counterparts in France and Germany, were able to operate as relatively autonomous entities with decentralized decision-making authority. • The dual structure of the university subsystem (public and private) promoted competition between medical schools. • The small amount of basic-facility funding of the universities led administrations to develop their own interest in acquiring outside resources. • In contrast, for example, to the German and French situation, the administrations at American medical schools are forced to incorporate the search for organizational resources into their routine organizational practices and develop, in this way, a basically entrepreneurial mentality of resource acquisition and investment. The interest of medical-school administrations in NIH grants is contingent, however: it is unimportant to them which sources medical schools ultimately tap to meet their financial needs. They also have no intrinsic interest in research, but only in the survival of their respective organizations. If funds for research decrease - and this situation has arisen in the United States today in periods of scarce financial resources - then other funding sources have to be found, and they are usually in patient care (Braun 1993c). Accordingly, the responsiveness of American structures to research funding is dependent on the ability of the sponsor to offer universities some added value in comparison to alternative sources of funding. The fate of the grants economy is directly dependent on the ability of NIH to continuously expand the resources it receives from political authorities and to pass these resources on to the scientific subsystem. Up until now, research in the United States has remained responsive to the research funding of NIH. NIH's general clinical research centers program provides an impressive example of this: • Even in clinical research, NIH hardly needs to make any active efforts to attract scientists and clinicians to work at such centers. • The research institutions do not need to be individually convinced to incorporate such centers into their facilities. • The institutional organization of the scientific subsystem allows for high mobility, thus ensuring the diffusion effects of the centers, something which is difficult to achieve in Europe due to the small size of the

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countries, the limitation of the number of scientific positions, and the lack of competition between universities. In contrast, European, and especially continental, structures of research burden sponsors with the task of having to develop an active search routine and special funding measures, in order to be able to organize clinical research. Neither hospitals nor medical departments exhibit great interest in research. Hospitals are usually firmly integrated into the health care subsystem. The actors who make resource decisions at hospitals and medical departments (i.e., the clinical administrations, health-insurance agencies and health ministries, university administration, and the self-governing bodies in the case of the medical departments) usually have developed no direct interest of their own in research. Thus, sponsors in Europe, especially if the implementation of structurally related instruments is involved, have to gain the cooperation of actors who are not primarily interested in research. This reduces the implementability of research ftmding. Another opportunity structure further enlarges the scope of influence of NIH research ftmding in comparison to that of its European counterparts. Of the approximately $9 billion that NIH has at its disposal, 30% is expended on universities to subsidize infrastructure in the form of indirect cost awards. Even though in times of cutbacks, such a high percentage must seem intolerable, it further increases the scope of influence of NIH's instrument set. The combination of directedftmdingand reimbursement of indirect costs of medical schools enables NIH to subject this basic university funding to performance-oriented grant criteria and thus protect the university research budget from being misused for other purposes. In contrast, the size of basic-facility funding of universities in European countries has hardly ever been determined according to research performance criteria; instead, other criteria, such as the size of the instructional burden, have been decisive. No distinction is made in university-directed appropriations between grants for research and those for teaching. Accordingly, resource competition between the functions of patient care, instruction, and research can lead to one function displacing another, in an uncontrolled manner, according to the relative strengths of these different ftinctions. Research is usually at a disadvantage here. In England, the American model was found attractive and some discussion has taken place about turning over the basic-facility research money of the (now) Higher Education Funding Councils to the research

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councils. Only recently this model was rejected in the White Paper of the government on future research funding. In France, however, a similar construct to that of the United States already exists, since the basic-facility funding (though of very small size) that the ministry of education provides to research teams at the universities requires researchers to take part in the research teams of the grands organismes. Only in Germany is basic-facility funding for universities, which is provided by the individual states, still strictly seperated from the research funding extended by the federal government. The large scope of influence of NIH is supplemented by the considerable latitude it has in formulating funding policy. The size of its funding resources is unmatched in the rest of the world; no organization in any other country has as much defining power in the funding subsystem; and science has especially great trust in NIH's research funding. There are, however, reservations to be made concerning the formulation of funding policies. The present report has distinguished between a strong political influence and a weaker political influence on the funding strategies of mission agencies. Hierarchical coordination closely ties the funding organization to the political administration and its various forms of procedural logic, whereas the system of dynamic equilibrium runs its course via negotiating arenas within the funding organizations themselves. Funding agencies finding themselves in the latter system have greater latitude in forming their own funding policies than their hierarchically coordinated counterparts. NIH can be categorized among the hierarchically coordinated on the basis of its integration into a government department (the DoH). It has, however, been able to gain a great deal of autonomy vis-i-vis the executive branch of government, due to the fragmented political structure existing in research policy. Nevertheless, NIH cannot simply and unrestrictedly do what it pleases. The political subsystem exerts influence through Congress. The existence of the Congress has both advantages and disadvantages for the scope of the formative powers of NIH: on the one hand, it was only by means of the congressional budgetary committees that NIH was able to reach the enormous level of research funding it receives today. On the other hand, though, the negotiations in Congress ultimately result in an exchange: in return for appropriations, members of Congress can expect consideration in the definition of funding topics. In this way, a whole series of target-area (priority) programs in specific fields of disease have arisen that enjoy

Conclusions: The Funding of Health Research

187

politically protected funding resources and that are in accordance with demands made by the general public and by Congress. Thus, NIH has to accept this limitation of its defining powers. In England and France, the political subsystem has a voice in the formulation of the general orientational framework of funding policy, but no dominating defining powers. Usually, scientific representatives possess a very important, co-determining negotiating position on decision-making committees. In the formulation of general ftmding policy, control attempts by one side can usually be blocked by counterefibrts of the other side. Funding policy is formulated in research councils by means of a negotiating subsystem that is predisposed toward compromise. In this way, the system of "dynamic equilibrium" does not grant the funding organizations unlimited freedom of action. It does, however, force representatives of both political and scientific interests to present their arguments and requests within a common discourse that ultimately seeks to give equal consideration to both sides. The German DFG belongs in several aspects to this group of funding agencies but enjoys considerably greater room for maneuver than its counterparts in England and France. German federal funding differs from other funding models in three ways: it is marked by (a) an internal differentiation of functions (the BMFT as the responsible decision-making authority, the project-grant agencies as the authorities implementing extramural funding, and the big-science centers [BSC] as autonomous research organizations), (b) a German funding subsystem much more internally differentiated than its non-German counterparts, and (c) a sharply hierarchical coordination of extramural funding. Internal differentiation has been detrimental to the coordination of intraand extramural research and funding policy. This contrasts to the situation of research councils, which combine intra- and extramural funding within one organizational body. Moreover, internal differentiation always entails the task of making different organizational interests, each with their own dynamic tendencies, compatible with one another. This costs time and requires negotiatory efforts. Similar consequences can be found in the German funding subsystem taken as a whole. The coordination of the domain claims of the various actors (DFG, Max Planck Society, Conference of University Rectors, the individual states, BMFT, and BSC) is one of the constant and

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time-consuming tasks of German ftmding. Moreover, the subsidiarity principle results in built-in inhibitions against putting existing arrangements up for discussion. The expansion of the existing funding authority of any one organization usually requires the agreement of the other actors in the funding subsystem. The model of extramural funding guarantees that the BMFT can define and control funding policies. In fact, though, such a construct also entails losses for research ftmding resulting from friction between different subsystems. Hierarchical coordination frequently suffers from problems in coordinating political-administrative logic with scientific logic and from the concomitant time costs of dealing with them. It runs the danger of being dominated by short-term and fragmented political interests, which can jeopardize the internal coherence of the structure of a program. And finally, it is also more difficult for it to gain the acceptance and cooperativeness of science than it is for funding organizations enjoying more room for maneuver. Accordingly, extramural federal funding in Germany - due to its organizational differentiation of functions and hierarchical coordination - has less scope in its formative powers than funding organizations elsewhere. There are a greater number of interests to integrate in Germany than in the other three countries. The network of actors, which in Germany takes the place of the strong corporate actor found in other countries, subjects research funding to politically changing opportunities and to the distribution of power of the given moment. The set of funding instruments available, in particular for dealing with the problems in clincial research, are of importance for the problem-solving capabilities of ftmding agencies. The following points are considered advantageous for removing obstacles in the transfer of basic biomedical research into clinical application: • The opportunity to implement intramural research and extramural funding at the same time within one's own organizational body; • A diversified set of instruments that allows the problems of health research to be approached with a wide array of measures; and • The ability to implement the funding instrument for a longer period of time if necessary, in order to produce structural effects

Conclusions: The Funding of Health Research

189

In German federal funding, extramural funding and intramural research, as described above, are still inadequately integrated with one another; in contrast, synergic effects in research funding can be reached by the other funding agencies by integrating these two activities within one organizational body. Not only can German federal funding cover a smaller range with the instrument set at its disposal, it is also less able to solve problems than are the funding agencies in the United States, France and England. Funding within the framework of the Federal Program is always short term in nature. This explains in part the problems of trying to realize structurally oriented objectives through the Federal Program. Interdisciplinary research can only be established in the long term, due to the nature of credibility cycles in social subsystems. Only secure resources and acceptance on the part of the institutions financially responsible can ultimately create the trust of scientists and clinicians required for investing in such risky fields. The responsible agencies of the Federal Program are forced to supplement their short-term program funding instrument with additional measures. Thus, in the clinical research teams established in conjunction with the DFG, the effort was made to compensate for the temporal limit to one's own funding. This was done by trying to convince the responsible institutions to assume financing of the clinical research teams at the end of the period of funding. This, however, makes one directly dependent upon the interests of the institution in question. The same holds for the interdisciplinary centers for clinical research that are now planned. Such a temporal discrepancy between structural goals and problem-solving ability does not exist in the other countries investigated. In these countries, the problem-solving capabilities of the instrument set is heightened by the fact that it is not unusual for extramural and structurally related instruments - of course, only after corresponding review processes to have funding periods of greater than 10 years, without the necessity of making funding dependent on the cooperation of the responsible institutions. The possibility of long-term implementation of funding instruments fulfils a decisive precondition for the participation of scientists and physicians in research located at the intersection of preclinical and clinical departments as well as at preclinical/clinical and public health departments. One advantage possessed by INSERM and MRC in this context is their ability to make themselves independent, in a certain sense, of the approval of actors in the scientific subsystem. By having intramural research teams

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whose composition and topics can be varied by the funding organization itself, it is possible to implant "interface research" at universities and hospitals without having the general acceptance of the authorities responsible for budgeting the host institutions. The hope is that the site of research and positive experiences with the research team will result in their long-term acceptance on the part of the universities and hospitals. Just because it is able to place these teams at medical departments and hospitals does not yet prove the problem-solving capabilities of this instrument. Both in France and England it was shown that the establishment of clinical research teams is not a sufficient condition of success. The teams often remained foreign bodies; they were not integrated into the disciplinary and organizational context of the institution. Thus, to ensure success, the use of research teams has to be connected to additional measures aimed at increasing their acceptability for the financially responsible authorities and by the actors in medical departments and hospitals. The activities of INSERM are exemplary in this context: intensive efforts have been made for several years to integrate the actors in the health subsystem in the formulation of funding policy and to more clearly orient one's own research in terms of the interest of these actors. The hope is that, in exchange, these actors will demonstrate greater interest in the concerns of research funding and actively support clinical research at universities and hospitals. If one considers the individual instruments that funding organizations use to raise the level of performance of clinical research, the model of U.S. clinical centers appears to have been the most successful. A large part of this success can certainly be attributed to the institutional structure found in the United States. Nevertheless, there are also features of this instrument, whose effects need not necessarily be dependent upon the institutional environment in which it is used: Clinical centers are set up for a longer period of time and thus reduce the apprehensiveness of scientists and clinicians that insufficient time will not allow them to use new investments to create a secure reputation in an interdisciplinary field. They free researchers from allocation mechanisms subject to internal organization constraints. They promote cooperation among researchers, since everyone is a "prisoner" of the same game. And finally, they display certain cost-saving aspects, since they concentrate resources. On the basis of these qualities, this instrument has apparently now also found acceptance in England and France.

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191

Funding agencies and political sponsors in general have had a less favorable impact on the development of public health research than they have had on clinical research. This report has argued that biomedical and clinical research is more attractive in terms of reputation than is public health research. And public health sciences have not been able - because of their highly fragmented composition, their close affinity to the social sciences, and the hegemony of their competitor, medicine - to gain the kind of institutional status within universities and within funding agencies necessary for attracting financial support for its research activities. Because of this, the public health sciences have become entangled within a circulus vitiosus: In order to do research which is not dominated by the considerations of outside disciplines, it had to apply for grants outside the universities. The only grants available for public health were awarded by actors (such as health ministries, foundations, and private health care associations) who had clearly defined self-interests in research results. As a result of this, public health has long been instrumentalized for extrinsic purposes. Instrumentalized science, however, lacks the time and resources to create a paradigm that can only be developed by doing basic research independent of the influence of external actors. Without a paradigm, however, its status within the university cannot be raised. Only during the last few years - as the cynical result of the suffering that AIDS has caused many people - has public health achieved the kind of public attention and financial resources it needed. Politicians in all countries realized that a disease like AIDS could only be fought against if public health had a sound scientific foundation. Since this point in time, the funding of basic research in public health has become more generous. In all the countries centers have been established for the integration of clinical and public health research and for the application of public health knowledge to the practices of public health experts, though still on a minor scale. This is an encouraging development which could help public health to develop into a more unified and accepted discipline. The danger, though, is that the good intentions of policymakers and funding agencies may dissapear once a remedy for AIDS is found. It is still to early to believe that the short-term attention cycle of politics no longer has validity in the field of public health research funding. The only realistic possibility for the long-term maintenance of public support for public health research would be its institutionalization within independent mission agencies. The establishment of the AHCP in the United

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States marks a beginning in this direction. Similar steps are yet to be taken in the European countries. The following can be said in summary: funding organizations can effectively intervene in the institutional order of research and the course of scientific research, if favorable institutional conditions are given within the scientific and health care subsystems, the organizational room for maneuver permits for flexibility in the development and make-up of the instrument set, and if this set allows for experiences from intramural research to be directly passed on into the development of funding instruments in extramural funding. In addition, this set should possess a relatively wide range of varied instruments and should include the implementation of long-term instruments for structural purposes.

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