Gene Therapy ResearchThe National Institute of Health and the Food and Drug Administration are the government agencies responsible for regulating gene therapy trials. The NIH oversees gene therapy clinical trials through the NIH Guidelines for Research Involving Recombinant DNA Molecules and the Recombinant DNA Advisory Committee (RAC). The Food and Drug Administration (FDA) also oversees trials through regulatory measures such as scientific review, testing, and inspection.10 After Jesse Gelsinger's death, the Working Group Advisory Committee on Oversight of Gene Therapy Clinical Research was established by part of the NIH. examine the purpose and role of the NIH in regulating gene therapy. It made several recommendations, many of which were adopted by the NIH as amendments to its research guidelines.12 In March 2000, two FDA and NIH initiatives were announced by the Department of Health and Human Services to increase the protection of people involved in gene therapy experiments. The first initiative, the Gene Therapy Clinical Trial Monitoring Plan, requires sponsors of gene therapy trials to regularly submit their monitoring plans to the FDA for review. The FDA will also inspect clinical trials to ensure plans are being followed and any problems are being handled. Additionally, expert gene therapy scientists will gather to discuss monitoring practices at inspector conferences. The second initiative, the Gene Transfer Safety Symposia, comprises a series of symposia held four times a year to discuss gene therapy data, inviting some of the most experienced authorities in their respective fields. The NIH and FDA are also providing support to other organizations interested in holding safety conferences on the topic of gene therapy.12Proposed review process3The NIH guidelines for gene therapy research have also changed since 2000. In an amendment to the guidelines guidelines governing gene transfer research, the NIH has changed the way research subjects are enrolled for gene therapy experiments. Under the amendment, clinical trial protocols must be submitted to the NIH's Office of Biotechnology Activities (OBA) for RAC review, and the RAC must complete its review before the Institutional Biosafety Committee (IBC) local authority gives its approval to the study. Subjects for research can only be accepted after the IBC and the International Review Board, IRB, approve the study.