Human Gene Transfer Experiments
Research involving the deliberate transfer of recombinant or synthetic nucleic acids into human subjects (gene therapy research) requires final approval from both the UNC Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB). The requirements for IBC review are outlined in Appendix M of NIH Guidelines. Applications for human gene transfer experiments are submitted via email to email@example.com.
NOTE: NIH Guidelines outline specific procedures for clinical trials at initial study sites. In such instances, the initial site’s IBC and IRB must determine whether the study represents novel risks by qualifying for any of the following criteria:
- The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; or
- The protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or
- The proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight and federal regulatory bodies to evaluate the protocol rigorously.
If the oversight committees determine the clinical trial does not meet the above criteria, initial approval will be granted with the stipulation of registering the study with the NIH Office of Science Policy. Final approval will be granted once the Investigator provides evidence of having completed the NIH OSP registration process.
If the oversight committees determine the study meets the above criteria, further review will be required by the NIH Recombinant DNA Advisory Committee (RAC). In such instances, approval will be granted after completing the NIH RAC review process.
Human gene transfer protocols approved by the IBC are considered approved by the IBC for the duration of the study provided:
- No protocol amendments involving changes to the recombinant or synthetic nucleic acids (including vectors, gene of interest etc) administered to human subjects have been made.
- No protocol amendments involving changes to the handling of the recombinant or synthetic nucleic acids by UNC employees, including waste disposal, personal protective equipment etc have been made.
If any such changes are made, an amendment must be submitted for review and approval by the IBC.
For assistance, email firstname.lastname@example.org.