Amendments to Streamline Review of Gene Therapy Trials and Transform the RAC to NExTRAC – April 2024: In August 2018, the NIH and FDA announced a joint proposal to streamline duplicative and burdensome oversight over gene therapy. In response, the NIH released an amended NIH Guidelines. The amended version removes the requirement to register and report on human gene therapy protocols under NIH Guidelines to NIH. Additionally, the RAC (NIH Recombinant DNA Advisory Committee) has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

Template for Reporting Adverse Events in Human Gene Transfer Trials (opens in Microsoft Word): The NIH Guidelines require that “any significant problems, violations, or any significant research-related accidents and illnesses” be reported to Office of Science Policy (OSP) within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).