Following approval by all appropriate bodies, the Human Gene Transfer Policy will be retired effective July 31, 2024. The retirement of the university policy will eliminate duplicative oversight already achieved through these processes as required by the Federal Policy for the Protection of Human Subjects (Common Rule). While the policy goes through the retirement process, the Human Gene Transfer Institutional Review Process SOP has been revised.
The university policy was originally issued in 2005 when human gene transfer (HGT) was new. Since then, regulations and perceptions surrounding HGT research have changed significantly. The retirement removes additional oversight including: IBC risk summary and risk matrix, requirement for IRB review to be performed by an Ohio State IRB, identifying the party responsible for reporting in the sponsored research agreement, CCC trial summary, CCC benefit matrix, CCC leadership approval of documents and trial, institutional approval for participant accrual by the executive vice president of the Enterprise for Research, Innovation and Knowledge, and monthly review and reporting by the Office of Research Compliance.
All human gene transfer clinical trials will continue to require the Institutional Biosafety Committee (IBC) and Institutional Review Board (IRB) approval moving forward.