NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 23, June 23, 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. 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 the following: DATES: September 18-19, 1995 TITLE: Contemporary Human Subject Issues in Academic Research LOCATION The University of Mississippi, Oxford, MS SPONSORS The University of Mississippi Jackson State University REGISTRATION Mr. D. Russell Cooper OPRR Conference Registration c/o Center for Public Service and Continuing Studies The University of Mississippi P.O. Box 879 University, MS 38677 Telephone: (601) 232-7282 FAX: (601) 232-5138 REGISTRATION FEE: $95 ($115 after September 5) DESCRIPTION: The biomedical and behavioral research currently being conducted within academic institutions promises exciting advances in scientific knowledge, as well as unprecedented opportunities for the betterment of individual and societal life. Increasingly, however, these dramatic achievements and opportunities are accompanied by scientific, ethical, regulatory, and legal intricacies, and dilemmas. Within the academic community, understanding these rapidly changing complexities is central to the IRBs ability to protect the rights and welfare of human research subjects while supporting scientific endeavor and its potential benefits to humankind. This conference is designed to examine a broad range of contemporary scientific, ethical, regulatory, and legal issues relating to biomedical, social, behavioral, and anthropological research involving human subjects. Each of these issues will be discussed within the framework of the academic research environment, and presentations will focus on the unique challenges presented to IRBs, researchers, subjects, and administrators in academic institutions. Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions on examining common IRB issues - including liability, informed consent, and deception - the conference will feature special focus sessions on issues related to historical perspectives, issues in mental health, the establishment, structure, and management of IRBs, computerized management information systems for the IRB office, FDA regulations for clinical trials, guidelines on inclusion of minorities and women, research involving genetic/DNA testing, and research involving special populations, including American Indians children, and elderly research subjects. Sessions will feature issues particularly pertinent to historically black colleges and universities and institutions newer to the IRB process. Speakers will include representatives from OPRR and FDA, including Dr. Gary B. Ellis, Mr. Paul Goebel, Jr., and Dr. Gary Chadwick, and other Federal agencies such as the Congressional Office of Technology Assessment, the Office of Research on Women's Health at NIH, and the National Institute of Mental Health. Distinguished members of the academic and clinical research community will also include Dr. William L. Freeman of the Indian Health Service, Dr. Diane Brown from the University of California at Berkeley, Dr. Ernest D. Prentice of the University of Nebraska, and Dr. John Estrada of Meharry Medical College. The format will encourage audience participation and informal information exchanges, with ample question and answer opportunities throughout the program. 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 x233 FAX: (301) 402-0527 .
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