Human Gene Transfer
IBC review of human subjects research
"Human Gene Transfer" or "HGT" is used to describe research involving the transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into human subjects. It is also sometimes referred to as "Gene Therapy." Nucleic acids (DNA or RNA) may be transferred as "naked" nucleic acid, encapsulated nucleic acid, or nucleic acid within another organism, such as a virus or within a cell.
The focus of the IBC HGT review is for the local oversight of biosafety aspects (e.g. administration, shedding) of HGT protocols.
The project must be submitted to both OHSU's eIBC and eIRB for review.
Note: Even if IRB review is waived to another IRB, OHSU will NOT waive Institutional Biosafety Committee (IBC) review.
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Human gene transfer is the deliberate transfer into human research participants of either:
- Recombinant nucleic acid molecules, DNA or RNA derived from recombinant nucleic acid molecules, or
- Synthetic nucleic acid molecules, DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
- Contain more than 100 nucleotides; or
- Possess biological properties that enable integration into the genome ( e.g. cis elements involved in integration); or
- Have the potential to replicate in a cell; or
- Can be translated or transcribed.
Investigators must submit to the IBC
Via the eIBC System:
- IBC Questionnaire for Human Subjects Studies
Via the eIRB System:
- Protocol and Investigator Brochure
- OHSU Consent form(s) (Note: the IRB has a Gene Transfer Consent form Template that should be reviewed for appropriate template language)
- Drug preparation instructions
Research teams should also review the Investigational Medication Dispensed to Research Subjects policy for additional requirements.
Project revisions and continuing review requirements
Follow IRB instructions as usual. The IBC will review all materials in eIRB and approve prior to IRB approval. If any change is needed to your IBC-specific documentation, the IBC office will contact you to complete a modification in the eIBC, otherwise, no additional eIBC submissions will be required.