NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 6, February 17, 1995 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, and will 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 Public Health Service agencies. The current schedule includes the following: DATES: February 23 & 24, 1995 TITLE: Regulating Human Experimentation in the United States: The Lessons of History 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 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. During 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 on American citizens during the Cold War are prominent in the media. Once again, reform must be linked 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 the critical implications for IRB performance and policy today. The first day of the conference will address questions such as, "Who were the primary sponsors of clinical research in the period preceding 1950?" Significant attention will be devoted to why the first subjects for human experimentation were so often recruited from minority group and institutionalized populations. The changing norms for informing subjects about clinical research and the place of human experimentation in popular culture and the media will be analyzed. Cold war research and its implications for current IRB operations and policy will be examined on the second day. In light of the historical record, the discussion will place particular emphasis on the use of vulnerable populations as human subjects in clinical research. DATES: May 4-5, 1995 TITLE: Contemporary Issues in Human Research Subject Protection in Vulnerable and Minority Populations: Sharing the Benefits and Burdens of Research LOCATION: Regal Riverfront Hotel, St. Louis, MO SPONSORS Washington University School of Medicine Jewish Hospital of St. Louis at Washington University Meharry Medical College REGISTRATION Barb Woodson Secretary, Research Administration Jewish Hospital of Saint Louis 216 South Kingshiway, Room 1768-69 Saint Louis, MO 63110 Telephone: (314) 454-8322 FAX: (314) 454-4241 REGISTRATION FEE: $150 DESCRIPTION: The HHS and FDA mandate to Institutional Review Boards is to protect the rights and welfare of human subjects while supporting scientific advancement. This protection is extended to all human subjects, but additional safeguards are provided by both the HHS/FDA regulations and basic ethical principles to protect the rights and welfare of vulnerable subjects who, by reason of their disability or illness, exhibit diminished personal autonomy. Neither the Federal regulations, nor ethical codes, including The Belmont Report, proscribe inclusion of vulnerable persons as research subjects, although special justification of any plan to involve vulnerable persons as research subjects is required. Women and members of certain racial groups -- particularly Afro-Americans and Hispanics -- have been excluded from research. Inasmuch as these groups have not been involved, they also are vulnerable -- vulnerable to exclusion and to the possibility of being deprived of proven new advances from research. This Conference will focus particularly on evolving concerns for the protection of vulnerable subjects from research risks, inappropriate or inadvertent exploitation, or discrimination by exclusion. Presentations will highlight FDA regulatory updates; explore the new guidelines for the inclusion of women and people of color and diverse racial and ethnic backgrounds in clinical research; examine the claims that women have been systematically excluded from research and potentially deprived thereby of proven diagnostic and therapeutic strategies; review current issues in research in vulnerable populations including unconscious patients in emergency rooms, AIDS patients, children, the elderly, and the cognitively-impaired. IRB challenges in research in psychiatry will be discussed, including the validity of initial and continuing informed consent for research in schizophrenic patients, justification for the use of a placebo, the social and medical implications of genetic screening for vulnerability to psychiatric disease, the ethical difficulties involved in research in child psychiatry, and the influence of cultural patterns on psychiatric research in minority populations. The Conference will include keynote addresses, panel presentations, facilitated forums, information exchanges, and active audience participation. An outstanding faculty of experts in each area of discussion has been selected on the basis of expertise and ability to communicate authoritatively and comprehensively. INQUIRIES For further information regarding these workshops and 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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