NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 41, November 25, 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: December 8-9, 1994 LOCATION Seven Hills Center San Francisco State University San Francisco, CA SPONSORS San Francisco State University, San Francisco, CA California State University, Los Angeles, CA REGISTRATION Darlene Yee, Ph.D. Chair, Committee for the Protection of Human Subjects Office of Research Sponsored Programs San Francisco State University 20 Tapia Drive San Francisco, CA 94132 Telephone: (415) 452-1908 FAX: (415) 338-6378 TITLE: Current Issues in Research Involving Human Subjects DESCRIPTION: Institutional Review Boards (IRBs) are charged with responsibilities for ethical review and oversight of the use of human subjects in research protocols. The primary principle governing the IRB's review and action is the protection of human subjects from risks while permitting the advancement of research. IRBs are faced today with complex concerns that require deep ethical and moral judgements, and they are challenged to act in an objective and timely fashion. Our workshop will focus on current issues in research involving human subjects: evolving concerns for protection of human subjects from research risks; FDA regulatory update; new guidelines on the inclusion of women and communities of color in clinical research; guidelines for human embryo research; ethics and philosophy of research with vulnerable populations such as children, the elderly, and those who are cognitively impaired and/or physically challenged; lessons learned from historical episodes in research; changing demographics of research in California; and emerging issues in research involving prisoners. The workshop formats will include facilitated forums, information exchanges, panel discussions, and active audience participation. We have assembled an outstanding faculty of distinguished experts to provide authoritative and provocative discussion of challenging issues in the field of human subjects research review. Participants will (1) learn how Federal regulations and community participation can protect human subjects in research, (2) become familiar with the issues involved in protecting the rights of vulnerable populations in research, (3) explore how regulations and community participation can collaborate to protect human subjects, (4) become more knowledgeable about policies, procedures, and expectations of an IRB, and (5) discuss the rights and responsibilities of researchers. INQUIRIES For further information on 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, MSC 7507 Bethesda, MD 20892-7507 Telephone: (301) 496-8101 FAX: (301) 402-2071 .
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