Human Gene Transfer (HGT)
Human gene transfer (HGT) is the deliberate transfer into human research participants of:
- Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules
- Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any of the following criteria:
- Contain more than 100 nucleotides
- Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration)
- Have the potential to replicate in a cell
- Can be translated or transcribed
The Office of Biotechnology Activities Oversight provides administrative support for HGT research for two separate reviews:
- We facilitate the pre-NIH registration review of HGT protocols for the assessment of whether public RAC review is warranted if the University of Minnesota is an initial site.
- We provide administrative support for the Institutional Biosafety Committee, which must review and approve all HGT experiments before they may be initiated.
All HGT experiments require registration with the NIH, and both approvals from the IBC and Institutional Review Board.
Pre-NIH Registration Review
- Use eProtocol to create an HGT application through the IBC eProtocol interface.
- Fill out the application via eProtocol as a “Human Gene Transfer—Human Subjects/Clinical Trial” activity.
- Use the first page of the "Protocol Information" section (1. Study Objectives) to note in the first sentence that the application is HGT—Pre-review and type the same information into the field called “Legacy Protocol ID.”
- Skip the attachment of the NIH RAC Registration letter (you will need to attach something here otherwise you will not be able to submit the application).
- Attach the required documentation as shown in the table in eProtocol (basically Appendix M of the NIH Guidelines). Note: There is duplication in materials in what eProtocol requires for HGT submission. The principal investigator (PI) should submit Appendix M, but there are individual attachments required that are actually part of Appendix M (see below).
- The PI must submit the eProtocol application (an email confirmation will be sent if successful).
- The PI must send an email to OBAO (firstname.lastname@example.org) noting the Protocol ID and that this application requires a pre-NIH Registration review for Human Gene Transfer.
- Upon receipt of the email, OBAO will send the PI a “PI HGT pre-review comments” file that must be filled out and returned by email. We will attached this file to the application.
- If the HGT protocol is registered with the NIH, submit an IBC application via eProtocol and attach all the required documentation.
- If you have previously submitted the HGT protocol for pre-NIH registration review via eProtocol:
- Use eProtocol to clone the previous application. This creates a new application with a different ID but is identical to the previous application.
- Adjust the application with any changes in the HGT section and attachments.
- Ensure you have attached the letter/email that confirms the NIH registration.
- Submit the eProtocol application.