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no-fault research insurance, which would obviously be the rational way to go. I am stunned by the disunited, piecemeal response of clinical investigators to this regulation. Sonnenreich pointed out that in many ways we are involved in a political struggle, and in a political struggle one must lobby for his position. He is right; but prior to lobbying one must get organized. We are not organized. We have many small professional organizations, each with its own set of interests. No interorganizational, united front has mobilized to say to HEW, "You are making regulations that have tremendous public impact. Although we are the substantively informed people in this area, we are being ignored. There should be no regulation without representation ." A task force representing the body of clinical investigators should be meeting regularly with appropriate units of HEW to discuss the need for the regulations. Regulations are now being proposed and promulgated without any formal contact of this sort. On regulations affecting psychiatric clinical research there is no contact between HEW and the American Psychiatric Association, the Psychiatric Research Society , the American College of Neuropsychopharmacology, the American Psychopathological Association, or the Society for Biological Psychiatry. We are fortunate that a few knowledgeable people have been acting as informal consultants to HEW on regulations, but there is no procedural setup. One outcome of this meeting should be an interorganizational task force that could make representations to HEW about being involved in formulating such regulations before they are published in the Federal Register. IRBs: Notesfrom the Discussion Institutional review boards are moderately useful bodies; they are responsible and hard working, and they probably improve the quality of research. They should be kept independent, serving to keep some regulatory power decentralized. Even so, can one regulate good medical practice? And how can IRBs deal with the issue of medical experimentation involving serious risk? Nothing should ever be done for the first time. It is very difficult to get first-time approvals, Levine agreed, but it is possible. It is not the job of the IRB to regulate good medical practice: the problem area is informed consent. Paper is more and more replacing the physician's talks with his patients, and the patients are getting angry about it. Douglass, under whose purview are the NIH study sections, believed Sl 18 Donald F. Klein ¦ A Slippery Slope that the relationship between the study sections and the IRBs is still unclear. He thought Levine's suggestion that the study sections attempt to resolve differences concerning the ethical aspects of grant applications immediately with IRBs was a constructive one. The study sections' work load has more than doubled in 6 years, with minimal increase in resources, and the system is badly overloaded. Some felt that it would be dangerous to license clinical investigators, as Klein proposed in his paper as one possible way to enhance trust. Perspectives in Biology and Medicine · Winter 1980 ¦ Part2 | Sl 19 ...


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