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Proposed rules set guidelines for clinical research on humans Proposed new Department of Health, Education and Welfare (HEW) regulations would sharply limit the participation of children, prisoners, and the mentally infirm in certain types of clinical research, and would establish review groups to ensure their protection. The proposals—which the department stresses are only in draft form—would set up two new review groups. The first, called Ethical Review Boards, would be organized within federal agencies to examine the ethical issues in any proposed research project. A second type of group, called Protection Committees, would be established at institutions that receive federal grants to do research. The committees' task would be to assess the validity of consent given by, or on behalf of, the research subjects. Obtaining valid consent on behalf of some subjects has long been a special problem. Children have been considered inappropriate subjects for many research projects, but as the draft
JAMA – American Medical Association
Published: Jan 7, 1974
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