The Council on Governmental Relations (COGR), representing 190 research universities and associated medical centers, submitted comments to the NIH Office of Science Policy regarding proposed amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. COGR generally supports the NIH’s intentions to streamline oversight of human gene transfer protocols by maintaining the current submission and safety reporting requirements, but limiting individual protocol reviews by the Recombinant DNA Advisory Committee (RAC) to exceptional cases meeting specific, risk-based criteria. They accept the proposed criteria for RAC review—such as first-in-human use of a vector, reliance on unvalidated preclinical models, or unexplored toxicities—but express concern that local oversight bodies may interpret these criteria inconsistently, potentially leading to complications when new clinical trial sites are added post-registration.
COGR also requests clarification in certain areas of the amended guidelines, particularly regarding the timing of subject enrollment under differing sections, and asks whether any special requirements for informed consent in human gene transfer trials remain following the removal of most guidance on informed consent. The organization welcomes the proposed reduction in submission document requirements, recommending that future guideline changes be presented with redlined comparisons to facilitate review. Additionally, they encourage NIH to issue clear guidance on the new processes, akin to resources provided for other research oversight policies. Overall, COGR appreciates the opportunity to comment and underscores the importance of clarity and consistency as regulatory responsibilities transition to local oversight bodies.
