NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 25, Number 24, July 19, 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. DATES: September 26-27, 1996 TITLE: Role of the IRB in Collaborative Research LOCATION: Jumer's Castle Lodge, Peoria, IL SPONSORS: University of Illinois College of Medicine at Peoria, Peoria, IL; Meharry Medical College, Nashville, TN REGISTRATION: Ms. Nancy Hibser IRB/OPRR/FDA/Conference University of Illinois College of Medicine at Peoria One Illini Drive P.O. Box 1649 Peoria, IL 61656-1649 Telephone: (309) 671-8437 FAX: (309) 671-8513 REGISTRATION FEE: $125 ($135 after September 16, 1996) 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 society 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 Institutional Review Board's (IRB) 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). Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions 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 special population, including children and elderly research subjects. Guest speakers will include representatives from OPRR: Mr. F. William Dommel, Jr., J.D., Dr. Kammal K. Mittal, and Ms. Darlene M. Ross; FDA: Dr. Gary L. Chadwick, Mr. Paul Goebel, Jr., Dr. Michael Norcross; NIMH: Dr. Andrea Baruchin. Distinguished members of the academic and clinical research community will also be present, including: Dr. Patricia Finn, St. Jude Children's Hospital at Memphis; Dr. Ernest Prentice, University of Nebraska; and co-host Dr. John Estrada, Meharry Medical College. The format will encourage audience participation and informational exchanges, with question and answer sessions 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 - 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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