NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 25, Number 17, May 24, 1996 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: July 25-26, 1996 TITLE: Protecting the Rights of Human Subjects in Research: Sharing the Benefits and Burdens of Research LOCATION: Alana Waikiki Hotel, 1956 Ala Moana Boulevard, Honolulu, HI 96815, telephone (808) 941-7275 SPONSORS: Kapi'olani Health Research Institute, Honolulu, HI; University of Hawaii, Honolulu, HI; Tripler Army Medical Center, Honolulu, HI REGISTRATION: Ms. Lora Young, Grants Assistant Kapi'olani Health Research Institute 1441 Kapi'olani Boulevard (18th Floor) Honolulu, HI 96814 Telephone: (808) 973-4759 FAX: (808) 973-8080 FEE: $120 DESCRIPTION: Topics to be discussed include: Protecting the Rights of Human Subjects: Today's Challenges; FDA Compliance Update; Report of Advisory Committee on Human Radiation Experiments; The IRB in Depth (Regulations; Policies and Procedures - What You Can and Cannot Review, Informed Consent, Expedited Reviews, Cooperative Agreements); Legal Issues in the Protection of Human Subjects (Access to Records: Hawaii Laws and Federal Regulations; Informed Consent; Liability Issues: The Institution Staff and Committee Members); Resolving Ethical Principles; Stressors for the IRB: Adverse Reaction Reporting Surviving Audits; The IRB's Obligation Regarding the Continuing Review of the Protocols; and Points for the IRB to Consider in Research Related to Human Genetics. 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 - MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov .
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