USA IBC REGISTRATION SUPPLEMENT
Human Gene Transfer / Recombinant DNA Research
Principal Investigator:
IRB # (if known):
Project Title:
Human Gene Transfer Research is defined by federal regulations as “any deliberate transfer of
recombinant DNA, or DNA or RNA derived from recombinant DNA (technology), into human research
participants.” Special provisions are necessary for conducting human gene transfer research at USA.
If your application involves Human Gene Transfer Research, please complete this form and include it
with your application to Institutional Biosafety Committee (IBC).
Section A.) Recombinant DNA Advisory Committee (RAC), review and recommendations. Please
provide all of the following information:
1.
One copy of the NIH Guidelines Appendix M-II: Description of Proposal
Note: If the study is supported by a non-USA sponsor, the sponsor should have already
completed the required submission to the NIH Office Biotechnology Activities (OBA) for RAC
consideration. USA investigators must contact the sponsor to request a copy of the RAC proposal
submission.
2.
All RAC correspondence and recommendations.
a). RAC approval or exemption letter
b). A copy of RAC recommendations for conduct of the trial, (if applicable)
c). One copy of the RAC reviewed protocol and sample consent documents (if applicable).
Note: If the study is supported by a non-USA sponsor, correspondence with the OBA RAC will occur
between the OBA and the sponsor’s PI. USA investigators must contact the sponsor to request all RAC
correspondence and recommendations.
aSection B.) Serious adverse event (SAE) reporting responsibilities to the OBA. Please provide all
l of the following information:
l Who is responsible for SAE reporting to the OBA? [ ] PI [ ] Other
If “other” please include a copy of the letter of delegation that is on file with the OBA
Principal Investigator’s Certification
� I certify that I have read the Guidance on Regulatory Requirements regarding Human Gene
Transfer Research.
� I will ensure that all personnel involved in the conduct of this study are aware of and will follow
the USA IBC’s guidance on Regulatory Requirements regarding Human Gene Transfer
Research.
Principal Investigator’s Signature
GeneTransferSupp.rtf (2/2006)
Date
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Gene Transfer / Recombinant DNA Research August 2005
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