Human Gene Transfer
Section III-C-1. Human gene transfer is the deliberate transfer into human research participants of either:
1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome ( e.g. cis elements involved in integration); or
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
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
- There may be additional requirements; please review the Investigational Agents Consisting of Recombinant DNA or Infectious Agents policy.
Project Revisions and Continuing Review Requirements:
Additional Requirements for Human Gene Transfer Trials:
Long Term Follow Requirements: FDA Guidance on Observing Subjects for Delayed Adverse Events