Abstract
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Commission) has made several recommendations for changes in federal regulations for the protection of human research subjects. Some of these changes will have important and felicitous consequences for biochemical pharmacologists who use human tissues and body fluids as research materials. For most—but not all—proposals to use such materials for research purposes, review at a convened meeting of an Institutional Review Board (IRB) will no longer be required. Similarly, requirements to use consent forms will be curtailed substantially; in some cases it will not even be necessary to negotiate informed consent. The recommendations of the Commission for these policy changes are grounded in recent clarifications of the following concepts: (1) the meaning of risk; (2) the purpose of informed consent; (3) the purpose of consent forms; and (4) the purpose of IRB review.
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