Regulatory overview: protection of human subjects--IRBS and informed consent.

The Food and Drug Administration (FDA) regulations on Institutional Review Boards (IRBs) and Informed Consent (IC) were published on January 27, 1981 and became operational on July 27, 1981. The historical development of these regulations began in August 1978 when the FDA proposed standards for IRBs. During the comment period, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report and recommendations on IRBs and informed consent. In its report, the National Commission recommended revision of the Department of Health and Human Services (DHHS) regulations and one uniform standard for IRBs. On August 14, 1979, the FDA withdrew the 1978 proposal and published a revised proposal that it had developed in conjunction with the DHHS in response to the recommendations made by the National Commission. Following consideration of the comments received on the 1979 proposal, the new regulations were published as final. I would like to discuss how these regulations relate to the FDA's mandate and regulatory responsibilities, to the work of IRBs, and to the protection of human subjects involved in the FDA-regulated research. I will also mention the FDA's internal organization to deal with IRB issues and, finally, what we may look forward to in the future.