NOT-99-009: WORKSHOP ON HUMAN SUBJECT PROTECTIONS

Department of Health
and Human Services (HHS)

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WORKSHOP ON HUMAN SUBJECT PROTECTIONS Release Date: January 22, 1999 P.T. 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: APRIL 21-23, 1999 TITLE: Research Involving Infants, Children & Adolescents" Issues and Ethics For the Twenty-first Century LOCATION: Hyatt Regency Crown Center 2345 McGee Kansas City, MO SPONSORS: Children"s Mercy Hospital, Kansas City, MO REGISTRATION CONTACT: Wellington Group Workshop Management Co. 4707 College Blvd., Suite 213 Leawood, KS 66211 Phone: 913-345-1990 FAX: 913-345-0893 REGISTRATION FEE: $175 before March 31, 1999, $200 after April 1, 1999 DESCRIPTION: As the new millennium approaches, now is the time to address issues that affect our most precious resource: our children. This will be one of the first opportunities to address and discuss the new federal policies for inclusion of children in human research. With keynote speakers and breakout sessions to address both legal and ethical issues, you"ll leave this workshop more informed, more effective and more excited about protecting research subjects than ever before. Plenary sessions include: (1) The Impact of Federal Regulations on Research Involving Children, (2) Parental Permission and Assent by Children: Therapy vs. Research The Patient s/Parent’s Understanding of the Elements of Assent/Permission, (3) The Risk of Not Doing Research Involving Children, and (4) Lost Souls in Pediatric Research: Cultural Diversity, Gender Neutrality and Special Needs Children. DATES: MAY 7-8, 1999 TITLE: Therapeutic Bias and Cultural Diversity: Two Barriers To Informed Participation In Research LOCATION: Olympia Park Hotel and Conference Center 1895 Sidewinder Drive Park City, UT 84060 801-355-0910 SPONSORS: The University of Utah School of Medicine, Salt Lake City, UT, Centro de La Familia, Salt Lake City, UT, Indian Health Service, Albuquerque, NM REGISTRATION CONTACT: University of Utah School of Medicine Continuing Medical Education 50 North Medical Drive Salt Lake City, UT 84132 Telephone: (801) 581-8664 FAX: (801) 581-3647 REGISTRATION FEE: $200 DESCRIPTION: This program is a combination of short lectures from acknowledged experts and focused working sessions with researchers, IRB members, and representatives of the research subjects community. Lectures and workshops are designed to focus on barriers to informed participation in research trials and to share strategies that make trials better understood, more equitable, and more representative of the ultimate patient population. Participants will act as an IRB in protocol, reviews, and receive constructive feedback. This program will be of interest to clinical investigators, epidemiologists, health educators, Institutional Review Board members, university and hospital administrators, lawyers, ethicists, potential research subjects, and representatives of different cultural communities. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Darlene Marie Ross, B.S. Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 435-5648 FAX: (301) 402-0527 EMAIL: dr20a@nih.gov

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