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Are there special requirements for protocols that involve gene transfer?

April 26, 2017gene involve protocols requirements special transfer

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Are there special requirements for protocols that involve gene transfer?

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Appendix M of the NIH Guidelines (http://www4.od.nih.gov /oba/rac/guidelines_02/Appendix_M.htm) describes additional considerations for gene transfer trials. Investigators are advised to review Appendix M early in the protocol development process to ensure that all requirements are met. In addition to IRB approval, approval will need to be obtained from the CUMC Institutional Biosafety Committee (IBC) and the Recombinant DNA Advisory Committee at the National Institutes of Health (NIH).