COGR Submits Comments on NIH Guidelines on Recombinant or Synthetic Nucleic Acid Molecules

COGR responded to the National Institutes of Health’s (NIH) request for public comments regarding proposed amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. COGR expresses support for the NIH’s intention to optimize the benefit of the Recombinant DNA Advisory Committee (RAC) review process by restricting detailed gene transfer reviews to exceptional cases meeting specific criteria, while maintaining essential protocol submission and safety reporting requirements. The organization does not object to the outlined amendments, acknowledging that Institutional Biosafety Committees (IBCs) and Institutional Review Boards (IRBs) will assume greater responsibility in determining when protocols warrant RAC review under the clarified criteria, such as first-in-human applications, reliance on novel preclinical data, or potential unknown toxicities. However, COGR notes potential challenges related to diverse interpretations of these criteria by local oversight bodies, especially when additional clinical trial sites are introduced after protocol registration. The letter requests clarification on areas where the amended guidelines appear inconsistent, particularly concerning the specific point at which participant enrollment may commence. Additionally, COGR seeks clarification regarding informed consent expectations in human gene transfer trials, following the removal of most related language from Appendix M-III. The organization also recommends providing redlined versions of proposed guideline changes to facilitate review and expresses appreciation for the streamlining of submission requirements. COGR requests that NIH offer further implementation guidance, such as detailed instructions and diagrams, and thanks the agency for the opportunity to provide feedback.