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LEGAL AND FINANCIAL ENCUMBRANCES TO CLINICAL RESEARCH MICHAEL R. SONNENREICH* Whenever I approach a subject such as clinical research, I am critically aware of the conceptual chasm which exists when the medical and the legal professions address an overlapping area of mutual concern. In the last 10-15 years, it has become increasingly apparent that there exists a collision of views, principally due to both professions defining the same issues differently and seeking different goals. The problems that arise from this language confusion and misunderstanding of goals are primarily manifested outside both professions, and this has resulted in public disenchantment and governmental regulation. It is no longer the case that questions involving research are worked out corporately among the individuals directly involved in the process, as it was in the past. The primary outside influence, government regulation, has changed the scenario and, due to its far-reaching and often unanticipated impact, altered dramatically the ability of persons involved in research to control , regulate, or perform their own activities and destinies. Within the last several years the legal profession, both in legal and ethical terms, has taken a more activist and dominant role with regard to medically related matters and especially clinical research. This awakening of legal interest in research issues, beyond the conventional issues of medical malpractice, has resulted in the courts and the regulatory agencies more closely monitoring the medical profession and in many instances substituting theirjudgment, under the rubric ofuniversality of application and paternalism, for that of medical professionals and researchers who traditionally dealt with these matters through peer review and scientific consensus. There appear to be two basic positions with regard to the input of law into the process and relationship surrounding clinical research. These positions are not always consistent, although they can be, and often tend to polarize opinion with regard to research. First, there is legal review of research activity to insure that it conforms to the broad confines of ?Chayet and Sonnenreich, P.C., Suite 720, 600 New Hampshire Avenue, N.W., Washington, D.C. 20037.© 1980 by The University of Chicago. 0031-5982/80/2322-0161$01.00 Sl 20 I Michael R. Sonnenreich ¦ Legal and Financial Encumbrances appropriate medical activity as defined by the medical community. Second , there is active review in which the legal system substitutes legal judgments on research activities to assure conformity with wider legal norms. There is an ever so delicate balance which must be maintained between these two basic roles of the legal system if excesses are to be avoided. Certainly, there are circumstances in which the medical profession has erred and the courts and regulators must play an active role in guiding the profession into a realignment of its position. However, such interventions must be very sparingly applied so that legitimate research processes and inquiries are not impaired. I believe that in clinical research this balance has not been maintained. Thejudiciary, the regulators, and even the legislators have been substituting theirjudgment increasingly in disregard of prevailing professional standards and mechanisms. Further, this process has assumed a self-perpetuating, somewhat evangelical character and will require a great deal of careful, persistent effort to halt its snowballing effect. Given the general governmental theorem that a regulation in effect tends to stay in effect and grow, clinical researchers will have to make an overpowering case against centralized government control over clinical research before regulatory growth can be arrested and restricted. Before detailing some of the primary areas in which the clinical investigator has lost control over the design and implementation of future research and in which the courts, regulators, and legislatures have substituted theirjudgments for that of the medical profession, I would like to summarize these issues. I will cover the following points in this paper. Informed consent üsues.—My thesis is that malpractice law, federal regulation , consumerist groups, and blue ribbon commissions have taken the lead (and, to a certain extent, co-opted the field) with regard to informed consent issues. Mechanisms of control established consequent to the reports of the National Commission on the Protection of Human Subjects place the hand of the federal government in almost every research protocol. Financial requirements for insurance and compensation of...


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