Research on Human Subjects

Research on Human Subjects: Problems of Social Control in Medical Experimentation

Bernard Barber
John J. Lally
Julia Loughlin Makarushka
Daniel Sullivan
Copyright Date: 1973
Published by: Russell Sage Foundation
Pages: 272
https://www.jstor.org/stable/10.7758/9781610440257
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  • Book Info
    Research on Human Subjects
    Book Description:

    How are human subjects treated in biomedical research? What are the expressed standards and self-reported behavior of biomedical researchers in regard to what has sometimes been called their "animal of necessity"? What are some of the determinants of the "strict" and "permissive" patterns which describe the standards and behavior of biomedical researchers? These are the important questions asked and answered inResearch on Human Subjects. It is a book based on four years of intensive research. Two studies were completed, one on a nationally representative sample of biomedical research institutions, a second on a sample of 350 researchers who actually use human subjects.

    In their chapters on "the dilemma of science and therapy," the authors look at the tension between the values of humane therapy and discovery in science. They show that the significant minority of researchers who are "permissive" on the issues of informed consent and a favorable risk-benefit ratio are more likely to be those who are "relative failures" in pursuing the science value.

    Research on Human Subjectsalso documents the inadequate training that biomedical researchers get in the ethics of research on human subjects not only in medical schools but in their postgraduate training as well. The medical schools pay relatively more attention to the scientific training of their students than they do to theethicaltraining that should be its essential complement.

    The local peer review groups that screen research on human subjects in the institutions where it is carried on are another central focus of attention of the research and analysis reported in this book. The peer review groups do a fairly good job but, the authors show, there are various conditions of their relative efficacy which are not met by review groups in many important research institutions. The medical school review groups, for example, have not been outstanding performers with respect to the several conditions of relative efficacy.

    In the concluding chapter, the authors discuss the general problem of the social responsibilities of powerful professions and make very specific suggestions for policy change and reform for the biomedical research profession and its use of human subjects.

    eISBN: 978-1-61044-025-7
    Subjects: Sociology, Health Sciences

Table of Contents

  1. Front Matter
    (pp. i-iv)
  2. Table of Contents
    (pp. v-vi)
  3. PREFACE
    (pp. vii-viii)
    BERNARD BARBER, JOHN J. LALLY, JULIA LOUGHLIN MAKARUSHKA and DANIEL SULLIVAN
  4. 1 INTRODUCTION
    (pp. 1-10)

    All during this century, but with especial frequency during the last thirty years, a large number of discoveries have been made in biomedical science. The area of therapeutic drug discovery and use may perhaps serve as an example of what is happening in many other areas of biomedicine. Three of what are now the eight major classes of prescribed therapeutic drugs were unknown thirty years ago. These three are the antibiotics, the antihistamines, and the psychoactive drugs. Two other major classes of drugs, the sulfas and vitamins, were introduced between World Wars I and II. Somewhat earlier in the century,...

  5. 2 RESEARCH DESIGN AND METHODOLOGY: THE TWO STUDIES
    (pp. 11-28)

    Our aim, as we indicated in the Introduction, was to collect valid, representative data on both the patterns and the social sources of conformity and deviance in researchers’ expressed standards and actual behavior with regard to two key issues in the treatment of human research subjects: informed consent and the proper risk-benefit ratio. Given our analytic assumptions about some of the major sociological variables that might be relevant to our task, assumptions which will be spelled out in detail as we proceed with our analysis in later chapters, we needed to collect data on at least the following six matters:...

  6. 3 IS THERE A PROBLEM? CURRENT PATTERNS OF ETHICAL STANDARDS AND PRACTICES
    (pp. 29-58)

    In the Introduction we stated that the data from our two studies, National Survey and Intensive Two-Institution Study, reveal two patterns in the ethical standards and practices of biomedical researchers. There is a conforming pattern and a deviant pattern or, perhaps better, there is a “strict” pattern and a “more permissive” pattern. The fact that the more permissive pattern exists suggests that there is indeed a problem in this area, that the increased concern shown by both the biomedical research community itself and the lay community over ethical standards of researchers whose studies use human subjects is not without some...

  7. 4 THE DILEMMA OF SCIENCE AND THERAPY: THE EFFECTS OF COMPETITION IN THE SCIENCE COMMUNITY
    (pp. 59-80)

    Having described the two patterns of expressed standard and behavior with regard to the use of human subjects in biomedical research, the patterns which we have called “strict” and “permissive” and which seem to represent the more conforming and more deviant responses to moral expectations in this field, we turn now to some explanation of the social sources of these different patterns. As we have said, our explanations fall into two broad classes. One, which will occupy us in later chapters, is a class that includes three different types of social control structures and processes: socialization, collaboration groups and informal...

  8. 5 THE DILEMMA OF SCIENCE AND THERAPY: THE EFFECTS OF COMPETITION IN THE LOCAL INSTITUTION
    (pp. 81-92)

    In Chapter 4 we examined the effects of the structure of competition for recognition and reward in the scientific community at large on biomedical researchers’ expressed standards and actual behavior in the use of human subjects. In this chapter we will show that somewhat analogous effects of the structure of competition in science exist at the local-institutional level where the individual researcher carries out his work and where the reward he seeks is organizational rank and its associated perquisites.

    Sociologists of science have long asserted, but without systematic empirical evidence, that the value ofuniversalismis an essential constituent in...

  9. 6 SOCIAL CONTROL: SOME PATTERNS AND CONSEQUENCES OF SOCIALIZATION
    (pp. 93-118)

    We turn now from our first explanatory variable, the conflict of equal values in socially structured situations, to our second one, the structures and processes of social control. In the previous two chapters we have seen how, in this biomedical research instance of value-conflict, the dilemma of science and therapy interacts with the competition structures of science to produce certain patterns of ethical conformity and deviance. Now, similarly, we wish to show how various social control structures and processes also contribute to determining these patterns.

    Among sociologists, the concept of social control is construed quite broadly and includes structures and...

  10. 7 SOCIAL CONTROL: SOME PATTERNS AND CONSEQUENCES OF COLLABORATION GROUPS AND INFORMAL INTERACTION STRUCTURES
    (pp. 119-132)

    The second type of social control we have studied consists of those structures and processes that bring the pressures of informal social interaction to bear on behalf of conformity or deviance. In this chapter, therefore, we inquire how scientific collaboration groups and other informal interaction structures may affect the “strict” and “permissive” patterns we have discerned among biomedical researchers. Here again we shall proceed by first reporting the methods and instruments we used to collect our data in this area. Then we shall suggest some of the ways that informal structures, just by themselves,mayinfluence expressed standards and actual...

  11. 8 SIX CASE STUDIES
    (pp. 133-144)

    After an extended and detailed analysis in the last four chapters of the patterns, social sources, and consequences of conforming and deviant behavior in the use of human subjects, we will now provide some concrete examples of the abstract structures and processes we have delineated. We have seen how the dilemma of science and therapy, the competition structures of science in both the larger community and local institutions, socialization processes, and collaboration groups and informal interaction structures affect our aggregated data. How do such necessary and useful analytic structures reveal themselves in concrete individual cases? We hope to show how...

  12. 9 SOCIAL CONTROL: THE STRUCTURES, PROCESSES, AND EFFICACY OF PEER GROUP REVIEW
    (pp. 145-168)

    We return now to our more systematic and abstract analysis. In this chapter we deal with the last of our three types of social control, peer group review, which is a set of formally defined structures and processes that various governmental (e.g., the P.H.S. and the F.D.A.) and individual biomedical research organizations have stipulated as necessary for producing normatively desirable social performance with regard to the use of human subjects by their grantees or members. This is the type of relevant social control where probably the largest changes have occurred in recent years and with probably the most consequential effects....

  13. 10 SOCIAL CONTROL: HAVE MEDICAL SCHOOLS BEEN ETHICAL LEADERS?
    (pp. 169-184)

    As we saw in our sketch of the evolution of peer review, the impetus to the reform of standards and practices in the use of human subjects in biomedical research has tended to come in much greater measure from governmental response to public outcry, a response showing itself in F.D.A. and N.I.H. regulation, than directly from the medical profession at large or biomedical research profession itself. There have, of course, been a few distinguished individual exceptions. For example, in addition to the effects of governmental regulation, some weight in pushing forward reforms in the use of human subjects has come...

  14. 11 THE SOCIAL RESPONSIBILITIES OF A POWERFUL PROFESSION: SOME SUGGESTIONS FOR POLICY CHANGE AND REFORM
    (pp. 185-198)

    Having presented all our findings and analysis, we wish to make some suggestions for policy change and reform. From the beginning of our research we have hoped that we could achieve two different but interrelated purposes. First, of course, we hoped to make a contribution to sociological theory and understanding. And second, we hoped that the theory and understanding arrived at through our research would result directly in specific and useful suggestions for policy change and reform. Indeed, the relation between our two purposes has been wholly reciprocal. For not only have theory and findings resulted in suggestions for policy...

  15. APPENDIX I. NATIONAL SURVEY QUESTIONNAIRE
    (pp. 199-232)
  16. Appendix II. INTENSIVE TWO-INSTITUTION INTERVIEW SCHEDULE
    (pp. 233-258)
  17. INDEX
    (pp. 259-263)