IBC > Guidelines > Gene Therapy/Genetic Research
Gene Therapy/Genetic Research
Individuals planning to conduct genetic research or gene therapy should consult Appendix M, page 92 of the NIH Guidelines for Research Involving Recombinant DNA Molecules as well as the IRB.
Review Of Human Gene Therapy Protocols
Human gene therapy protocols are subject to dual review by the IBC and the Institutional Review Board (IRB). A joint IBC/IRB Committee will review both human subject and biosafety issues. The IBC members, chosen for their expertise in the area of the protocol, will review the protocol in accordance with the regulations established for the review of new protocols. The committee shall make recommendations to the IBC and IRB for final approval.
Most new protocols will receive a full IBC review. However, under special circumstances an expedited review may be conducted by at least two designated reviewers from the appropriate Committee(s) in accordance with the NIH Guidelines and/or other federal regulations. The RO-11 form and a written description of the protocol is provided to the reviewers, who may call for a full review, if necessary. The reviewers shall be given five working days to complete the review. Expedited review may not be used for protocols involving BL2/BL3 or BL3 containment.