Gene therapy studies are becoming increasingly common as the US FDA and other countries have begun issuing approvals for gene therapies, particularly in the field of oncology. Gene therapy studies pose exciting advancements for clinical research but also involve additional risks and regulatory requirements. Gene therapy studies receiving federal funds or taking place at sites receiving federal funds, require review by both an IRB and an Institutional Biosafety Committee prior to registering with the National Institutes of Health (NIH). Further review may be required by the NIH Recombinant DNA Advisory Committee (RAC). This presentation will summarize the current state of gene therapy research and the associated risks. Attendees will learn how to obtain the necessary regulatory approvals and prepare sites to conduct gene therapy research.