The Impact of Institutional Review Boards on Clinical Research

THE IMPACT OF INSTITUTIONAL REVIEW BOARDS ON CLINICAL RESEARCH* ROBERTf. LEVINEf Since I do not know what the impact ofthe Institutional Review Board (IRB) is or has been, I shall focus on what it could or ought to be. I begin with the basic premise that the IRB, as now designed, is somewhat more beneficial than harmful to the biomedical research enterprise. Through intelligent remodeling of the structure and function ofthe IRB, the ratio of the benefits it produces to the harm that it causes can be made much more favorable than it is now. I shall identify some factors in current and proposed federal policy that I think will influence this harm-benefit balance and suggest that we should support those that would make it more favorable and resist those that would make it more harmful. The role of the IRB is defined adequately by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter, the Commission) in its Report on IRBs: "The ethical conduct of research involving human subjects requires a balancing of society's interests in protecting the rights of subjects and in developing knowledge that can benefit the subjects or society as a whole. . . . Investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others who are independent of the research must share this responsibility, because investigators are always in positions of potential conflict by virtue of their concern with the pursuit of knowledge as well as the welfare of the human subjects of their research" [1, p. I]. To that I would add that, since this is an age of specialization, most investigators are not aware of all of the interests of subjects and of society that deserve consideration. For that matter, it is a rare IRB member who has such total awareness; therefore, to use the old NIH language, "group consideration" is required . ?Portions of this chapter are derived from articles published in IRB: A Review ofHuman Subjects Research [10, 13, 18] and theHastings Center Report [5]. This has been done with the permission of the holder of the copyright for both, The Hastings Center Institute of Society , Ethics, and the Life Sciences. tDepartment of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut 06510.© 1980 by The University of Chicago. 0031-5982/80/2322-0159$01.00 S98 I Robert]. Levine ¦ Institutional Review Boards The Commission believes (and I concur) that the rights of subjects should be protected by local review committees operating pursuant to federal regulations and located in institutions where research involving human subjects is conducted . Compared to the possible alternatives of a regional or national review process, local committees have the advantage of greater familiarity with the actual conditions surrounding the conduct of research. Such committees can work closely with investigators to assure that the rights and welfare of human subjects are protected and, at the same time, that the application of policies is fair to the investigators. They can contribute to the education of the research community and the public regarding the ethical conduct of research. The committees can become resource centers for information concerning ethical standards and federal requirements and can communicate with federal officials and other local committees about matters of common concern. [1, pp. 1-2] In my opinion, the single most important factor that contributes to the successful functioning of the IRB is its credibility within the institution that it serves and within the community that the institution serves. My arguments supporting this opinion are published [2, pp. 4.1-4.73]. Without credibility, the IRB cannot perform its functions. Some of the more important factors relevant to the credibility of the IRB are: 1.The IRB must have a membership that merits the respect of persons within the institution as well as within the community. 2.The IRB must concentrate on doing important things. If it invests too much energy in doing trivial things, the IRB will not have the time and energy to perform its legitimate and consequential functions. It will develop an image within the institution as a group that is totally preoccupied with trivia and therefore to be avoided...