NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 42, December 2, 1994 P.T. 42 Keywords: Human Subjects Policy National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: DATES: February 23 & 24, 1995 LOCATION Kellogg Conference Center, Columbia University, New York, NY SPONSORS Columbia University, New York, NY Harlem Hospital Center, New York, NY The John Conley Foundation for Ethics and Philosophy in Medicine, Inc., New York, NY REGISTRATION David J. Rothman, Ph.D. Bernard Schoenberg Professor of Social Medicine and Director College of Physicians and Surgeons Columbia University 630 West 168th Street, Black 101 New York, NY 10023 Telephone: (212) 305-4184 FAX: (212) 305-6416 REGISTRATION FEE: $200 TITLE: Regulating Human Experimentation in the United States: The Lessons of History DESCRIPTION: The current organization and operation of Institutional Review Boards (IRBs) cannot be understood apart from the history of human experimentation. During the 1950s and 1960s, a series of exposes and scandals created the pressure for reform and oversight of clinical research. Over the 1970s, regulations were enacted that reflected an increased public awareness of the atrocities committed by Nazi doctors during World War II and such American incidents as Tuskegee, Willowbrook, and those described by henry Beecher in his whistle-blowing 1966 New England Journal of Medicine article. Today, exposes of experiments with radioactive materials and mind altering chemical substances of American citizens during the Cold War are now prominent in the media. Once again, reform must be like to an understanding of history. The past record is of primary relevance to the design of an effective public policy in human experimentation for the 21st century. Hence, this two day conference will explore the history of human experimentation in the United States in the 20th century and analyze its critical implication for IRB performance and policy today. The first day of the conference will address such important and heretofore unexplored questions as who were the primary sponsors of clinical research in the period preceding 1950. It will devote significant attention to why the first subjects for human experimentation were so often recruited from minorities and institutionalized populations. It will also analyze the changing norms for informing subjects about clinical research and the place of human experimentation in popular culture and the media. The second day will examine cold war research and draw out its implications for current IRB operations and policy. In light of the historical record, the discussion will place particular emphasis on the use of vulnerable populations as human subjects in clinical research. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 FAX: (301) 402-0527 .
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