Human Gene Transfer
Overview
“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.” HGT is currently being investigated by researchers at the Ohio State University in a variety of human diseases to see whether it can treat certain health problems by supplying a missing protein, compensating for a defective gene, providing a therapeutic substance, or activating the subject’s own immune response.
Because it touches on a number of scientific, medical, ethical and safety issues, the NIH mandates that all HGT research be reviewed and approved in a publicly accessible manner by the Recombinant DNA Advisory Committee (RAC). The federal RAC committee includes experts in a variety of fields including medicine, genetics, and ethics who review proposed human gene transfer research in the context of current technology and scientific understanding of recombinant DNA research. The RAC advises the NIH Director and the NIH Office of Biotechnology Activities (NIH OBA), the office charged with oversight of recombinant DNA research. NIH OBA is responsible for publishing and updating the NIH Guidelines for Research Involving Recombinant DNA Molecules (“NIH Guidelines”). The NIH Guidelines set forth the guiding principles regarding oversight and provide specific guidance on the conduct of human gene transfer to ensure the safe handling and containment of recombinant DNA.
In addition to federal RAC review and approval, HGT research must be reviewed and approved locally by the Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB). Lastly, all HGT research at the Ohio State University must undergo a formal institutional review and approval process. For additional information on conducting HGTs at the Ohio State University see the institutional policy on Human Gene Transfer along with the Human Gene Transfer Flowchart for an overview of the Institutional Review Process.
The Institutional Biosafety Committee (IBC) helps coordinate the HGT review process at the University, which is briefly described above. The first step is that investigators should register their HGT research with the IBC. For more information, see the Investigator Guidance. For general information on HGT clinical trial research contact Jennifer Yucel, Ph.D., Research Compliance Administrator at jennifer.yucel@orc.osu.edu or (614) 247-8831.
