Human Gene Transfer
NIH Guidelines for Research Involving Recombinant DNA Molecules
Section III-C-1. Experiments Involving the Deliberate Transfer of Recombinant DNA, or DNA or RNA Derived from Recombinant DNA, into One or More Human Research Participants.
Review Requirements
Human gene transfer proposals must first be submitted to the NIH Office of Biotechnology Activities (OBA) for review-see Appendix M-I-A. Requirements for Protocol Submission. See also, Frequently Asked Questions (FAQs) about the NIH Review Process for Human Gene Transfer Trials (information provided by the NIH OBA).
Once NIH OBA review is complete, the project must be submitted to both OHSU's IBC and IRB for review.
Investigators must submit to the IBC:
- Completed responses to Appendix M-see Appendix M-II. Description of the Proposal
- Memo from NIH/OBA certifying RAC review is complete, and any additional RAC questions with response
- Protocol and Investigator Brochure
- Consent form (use OHSU Gene Transfer Template); also see Appendix M-III. Informed Consent, and specific requirements for human gene transfer consent forms M-III-B-2
- Drug Preparation Instructions
- Subject Gene Therapy Education Materials
- Gene Therapy Subject Identification Card
- There may be additional requirements; please review the Investigational Gene Therapy Agents policy.
Project Revisions and Continuing Review Requirements:
Follow IRB instructions as usual. The IBC will review all PRAFs and Continuing Review materials and approve prior to IRB approval.
Additional Requirements for Human Gene Transfer Trials:
Appendix M-I-C-3. Annual Reports A copy of the annual report must be submitted to the IBC (submit using the electronic IRB) when available
Appendix M-I-C-4. Safety Reporting
See also: FDA Guidance on Observing Subjects for Delayed Adverse Events (long term follow requirements)
