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| NIH Guidance on Informed Consent |
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Prior to the first clinical gene transfer trial enrolling subjects, the National Institutes of Health (NIH) and its Recombinant DNA Advisory Committee (RAC) have sought to assist investigators in developing good consent forms and processes for clinical gene transfer research. Specifically, Appendices M-III and M-IV of the NIH Guidelines address points and issues related to informed consent that would benefit from particular attention. These appendices address issues unique to gene transfer, as well as issues that gene transfer has in common with other forms of clinical research.
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The requirements of Appendix M were always intended to be complementary to and are consistent with other requirements, regulations, and guidance documents, including 45 CFR 46, 21 CFR 50, and 21 CFR 56, and other guidance from the Office for Human Research Protections and the Food and Drug Administration. However, even after the promulgation of Appendix M-III and M-IV, NIH has continued to seek ways to assist investigators and others involved in the consent process for gene transfer trials.
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In 2002, the NIH Office of Biotechnology Activities (NIH OBA) formed a RAC Informed Consent Working Group - composed of members of the RAC, outside experts, and representatives of the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) - to assist the in the development of a comprehensive, web-based guidance document to supplement Appendix M. After an extensive development process, the guidance document was endorsed by the RAC in December 2003.
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Go directly to the web-based guidance document.
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