New Resources from the NIH Office of Biotechnology Activities April 22, 2004 Medical Research Summit Washington, D.C.

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Presentation transcript:

New Resources from the NIH Office of Biotechnology Activities April 22, 2004 Medical Research Summit Washington, D.C.

New Resources from the NIH Office of Biotechnology Activities Genetic Modification Clinical Research Information System (GeMCRIS) –A public database of human gene transfer trials registered with the National Institutes of Health Informed Consent Guidance –A new resource for investigators, IRBs, IBCs, potential research participants, and others concerned with informed consent in gene transfer trials

New Resources from the NIH Office of Biotechnology Activities Genetic Modification Clinical Research Information System (GeMCRIS)

Key Features of GeMCRIS: On-line adverse event reporting to NIH –One format for NIH and FDA Security measures to protect trade secret and patient confidential information On-line search capability Implementation of controlled medical vocabularies Controlled scientific vocabulary developed specifically for gene transfer research

GeMCRIS: Key Information Protocol title Study phase Clinical indication(s) Investigator(s) Clinical trial site(s) Scientific abstract Non-technical abstract Investigational strategy Vector Transgene Route of administration

Accessing GeMCRIS: Connect to:

New Resources from the NIH Office of Biotechnology Activities NIH Guidance for Informed Consent for Gene Transfer Research

Informed Consent Guidance for Gene Transfer Research Impetus RAC review of informed consent documents revealed that investigators were having difficulty conveying important concepts pertinent to gene transfer research and to human subjects research more generally –inappropriately positive description of benefits –therapeutic misconception –presumptive use of the first person pronoun (“I understand that...)

Informed Consent Guidance for Gene Transfer Research Intent Assist gene transfer investigators with the development of forms and with the communication process Educate other users (IRBs, IBCs, potential participants) about important issues related to informed consent Serve as a model resource for the research and IRB community more generally Not new policy or an amendment to Appendix M

RAC Informed Consent Working Group Baruch Brody (co-chair) Baylor College of Medicine Nancy King (co-chair) University of North Carolina James Childress University of Virginia Bernie Lo University of California, SF Sue Levi-Pearl Tourette’s Syndrome Ass’n Diane Wara University of California, SF Kristina Borror (OHRP) Cynthia Rask (FDA) OBA staff (NIH) Roster

Accessing this Resource Connect to:

For Updates on All OBA Initiatives Subscribe to OBA_NEWS – to: –In body of message: subscribe OBA_NEWS

Office of Biotechnology Activities National Institutes of Health 6705 Rockledge Drive Suite 750, MSC 7985 Bethesda, Maryland Phone (301) Fax (301)