The NIH Guidelines has specific requirements regarding any rDNA research that involves human participants. Appendix M of the NIH Guidelines outlines the procedure when submitting rDNA protocols involving human subjects. Also covered in this appendix are criteria used by RAC (Recombinant DNA Advisory Committee) and the IRB (Institutional Review Board) when reviewing such protocols and requirements for the initiation of the clinical investigation and annual reporting. It is the responsibility of the PI to ensure all aspects of Appendix M have been addressed prior to submission of a human gene transfer experiment to NIH/OBA.
Submittal procedures include:
- Submitting a research protocol to RAC, and at the same time submit a copy to the Biosafety Office as notification of pending RAC review.
- Forwarding any correspondence from RAC, response(s) to RAC recommendation (if applicable) and a completed and signed copy of the University’s rDNA registration document to the Biosafety Office, 100 EHS.
After IBC review, an approval/disapproval letter will be emailed to the PI through UIRIS. The PI must forward a copy of the approved rDNA document, available on UIRIS, to the funding agency, if required. The PI must submit to OBA specific documentation (described in Appendix M of the NIH Guidelines) within 20 days after enrollment of the first research participant. Annual data report forms sent by NIH OBA must be completed and a copy forwarded to Haley Sinn, EHS, 100 EHS.