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COMMENTARY AND DISCUSSION A Slippery Slope DONALD F. KLEIN* It might help us in thinking about regulation of clinical research to step back and look at the social framework and the social history in which the IRB regulations have developed. At this conference I noticed how often people referred to issues of trust and credibility, and I think that is actually the key situation here. The basic issue is a lack of trust by some segments of our society in the scientist conducting human experimentation . This lack of trust has not been generated by some large, documented number of instances in which the experimenter-subject relationship was defective. There have been a couple of pre-IRB howlers, but only a few—very few. I know of no body of data indicating that such research abuses are common or current. Therefore, it seems that the lack of trust is not based so much on historical facts as on the mere potential for abuse, given the experimenter-subject relationship, where the experimenter is believed placed in a conflict of interest and the subject is thought, for some reason, to be unusually vulnerable. Our society has many situations in which a professional relationship places the professional in a possible conflict of interest and the subject is unusually vulnerable. One could argue that dentists have good reason to make the most expensive and extensive recommendations to a distressed patient, made vulnerable by his toothache, rather than to do the job in the most economical and valid way. Nonetheless, the only assurance society gives that the dentist's conflict of interest and the patient's vulnerability do not result in exploitation is that the dentist must complete professional schooling and obtain licensure. There is no system ofreview prior to any proposed action. Recently, systems referred to as PSROs ?Director of Research, Office of Mental Health, New York State Psychiatric Institute, 722 West 166th Street, New York, New York 10032.© 1980 by The University of Chicago. 0031-5982/80/2322-0160$01.00 Perspectives in Biology and Medicine ¦ Winter 1980 ¦ Part 2 Sl 15 (professional services review organizations) have developed, but these are systems for post-hoc review of professional actions. Similar arguments relate to all professional relationships. The usual social mechanism is prior restraint of a class of actors rather than prior restraint of an act. You have to be duly educated and licensed to be a physician, lawyer, etc. It would seem that there should be ample evidence provided to circumvent this traditional procedure by a prior restraint in the form of third-party intervention, as with the IRBs. Nonetheless, that is what has happened to research with human subjects. Without demonstration ofany major, real, historical risk, the mechanism of the IRB has been developed. It is interesting that the historical stage of board certification or licensure has been skipped over by current regulations, probably due to the very rapid development of the field of human experimentation in the past 30 years. Instead of developing a system of licensure for human experimenters, which would help professionalize this group and probably to some degree engender public confidence, we have leaped into the Institutional Review Board mechanism . Unfortunately, once one is involved with prior restraint of particular actions, the complications ramify indefinitely. The problem is that the entire procedure involved in recruiting subjects for research, gaining their meaningful participation, maximizing their protection, carrying out the research, etc., is not a one-step affair but a tremendous sequence of events. The National Commission and current regulations have decided that the individual human experimenter cannot be trusted to go it alone. The response has been to erect a new guardian of the public interest in the form of the Institutional Review Board. The trouble is that now the distrust extends to the IRB: how do we make sure that they will be ethical and competent? In an attempt to assure this, regulations proliferate concerning every possible contingency involving all stages of the research process. My work has been primarily in psychiatric research, which provides an outstanding example ofhow bad things can be because ofthe promulgation of the proposed regulations on the institutionalized as mentally disabled. Briefly, these regulations...


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