Human Gene Transfer (HGT/s)
Human gene transfer is the process of transferring genetic material (DNA or RNA) into a person. For an experiment involving the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human research participants, no research participant may be enrolled until: 1) the RAC review process has been completed; and (2) IBC and IRB approvals and FDA and all other applicable regulatory authorization(s) have been obtained.
The oversight process for this type of research is being developed. Check back for updates.