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 If your application transfers recombinant
DNA, or DNA or RNA derived from recombinant DNA, into research participants, you'll need
additional approvals.
The NIH Recombinant DNA Advisory Committee must review your application before review by your institutional biosafety committee, FDA, and your IRB or IEC. Send NIAID written documentation, including comments, of those reviews and approvals.
For more information, go to the NIH Office of Biotechnology Activities Web site and the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Additional Resources
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