Download Human Gene Transfer/Recombinant DNA

DEPARTMENT OF RESEARCH
Institutional Review Board
Human Gene Transfer / Recombinant DNA Research
Principal Investigator of IRB Application:
IRB # (if known):
Study 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 LBH.
If your application involves Human Gene Transfer Research, please complete this form and include it with your
application to the Institutional Review Board (IRB).
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-LBH sponsor, the sponsor should have already completed the
required submission to the NIH Office Biotechnology Activities (OBA) for RAC consideration. LBH
investigators must contact the sponsor to request a copy of the RAC proposal for 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).
3. Provide an overview of the progress of this application from its inception. Include a time-line (dates) for
each milestone accomplished.
NOTE: If the study is supported by a non-LBH sponsor, correspondence with the OBA RAC will occur between
the OBA and the sponsor’s PI. LBH investigators must contact the sponsor for this information.
Section B. Serious adverse event (SAE) reporting responsibilities to the OBA. Please provide all of the
following information:
Who is responsible for SAE reporting to the Office Biotechnology Activities (OBA)?
If “other” please include a copy of the letter of delegation that is on file with the OBA
LBH IRB Form # 18: Human Gene Transfer / Recombinant DNA Research
Ver. 1 - 11/2/06
[ ] PI
[ ] Other.
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Principal Investigator’s Certification
 I certify that I have read LBH IRB Guidance regarding Human Gene Transfer/Recombinant DNA Research
 I will ensure that all personnel involved in the conduct of this study are aware of and will follow the LBH IRB
guidance regarding Human Gene Transfer/Recombinant DNA Research.
Principal Investigator's Signature
LBH IRB Form # 18: Human Gene Transfer / Recombinant DNA Research
Ver. 1 - 11/2/06
Date
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