A Social Organizational Approach to Problems of Ethics in Clinical Research

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A SOCIAL ORGANIZATIONAL APPROACH TO PROBLEMS OF ETHICS IN CLINICAL RESEARCH DAVID R. MAINES* and ATTALLAH KAPPASÎ The quality of professional judgments made by clinical investigators with respect to the rights of patients is the ultimate target of the recent increases in attention being paid to issues ofethics in biomedicine. That attention frequently takes the form of a type of drama played out not only in research settings but in courts, legislative bodies, and the public media. It is a drama precisely because it reminds us ofthe delicate nature of social existence and of the fact that in pluralistic societies the lines differentiating freedom and victimization of individuals are sometimes quite ambiguous. In these issues of biomedical ethics, passions frequently become aroused, and in response, various sectors ofsociety seek to promote means through which the rights of experimental human subjects might be protected. Lawyers tend to advocate the passing ofnew laws, the federal government enacts an elaborate set of guidelines, ethicists speak prolifically about the moral climate of society, and scientists respond scientifically by conducting studies of risk/benefit ratios [1, 2]. Ostensibly all are sincere, and no doubt if problems ofbiomedical ethics are to be resolved, an approach representing the varied interests of society is needed. Clinical investigators can contribute to the solving of such problems if they are able to act on a better understanding of patterns of behavior which occur within clinical research settings. It is the researcher-patient relationship that, after all, occupies center stage of the drama, and it is the roles of both parties in this relationship with which we should be most concerned. An assumption underlying attempts to protect the rights of research patients is that if left to themselves clinical researchers would periodically violate those rights in the name of science. This assumption strikes at the heart of the physician-patient relationship, because it calls into»Present address: Center for the Study of Health Services, Yale University, New Haven, Connecticut 06520. tRockefeller University Hospital, New York, New York 10021. We gratefully acknowledge the helpful comments of Professors Bernard Barber and Eliot Freidson.© 1978 by The University of Chicago. 0031-5982/78/2104-0029$01.00 606 I David R. Maines and Attallah Kappas ¦ Ethics in Clinical Research question the compassion which physicians have for their patients. It also challenges the traditional basis of professional autonomy in medicine, which historically has rested on claims of superior knowledge and skills and has expressed itself in such a way that physicians require that patients trust their professional judgments [3]. It is that very trust that is being questioned. The implications concerning professional autonomy in these matters are complex. One fact stands out, however, which not only should be of special interest to clinical researchers but which presents them with a problem of substantial dimensions. It is evident that in an attempt to protect the rights of patients, legal guidelines and review boards represent the imposition of a bureaucratic structure on the biomedical research process. These bureaucratic instrumentalities, while necessary to some extent, clearly have the effect of externally limiting professional medical autonomy [4]. The defining characteristic of a profession, however , is internal control, or self-regulation [3]. Ifbiomedical researchers wish to retain a measure ofcontrol over their work, therefore, they must engage in activities which will have the effect of producing or maintaining that control. One step already being taken, ofcourse, is the conducting of risk/benefit studies; but as we will suggest, such studies can have only limited usefulness. In fact, there is no single approach which in itselfcan improve the quality of professional biomedicaljudgments concerning ethical issues which does not take into account the social organizational nature of clinical investigation. This approach is one which has not been seriously explored by the medical profession. It is the purpose of this paper to discuss the elements of social organization in clinical research and how knowledge of them might improve the quality of biomedicaljudgments in relation to research ethics. This approach directs attention to patterns ofprofessional activities. It is important to consider these patterns because biomedical research projects are increasingly becoming collaborative in nature [5, p. 192], a fact reflected in part in the increase...

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