The document is a formal joint response from major academic associations—AAMC, AAU, APLU, and COGR—to the National Institutes of Health’s (NIH) proposed changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The associations express general support for the efforts to streamline oversight and reduce duplicative reporting in human gene transfer (HGT) clinical research, while sharpening the Guidelines’ focus on biosafety issues. However, they voice significant concerns about the proposed deletion of Appendix M, arguing that its removal would leave institutional biosafety committees (IBCs) without a clear framework for assessing biosafety in HGT research. They recommend retaining relevant guidance from Appendix M and urge clearer articulation of IBC expectations in the updated Guidelines.
Additionally, the letter highlights that evolving technologies such as CRISPR and synthetic biology are not adequately addressed in the existing Guidelines, underscoring the need for comprehensive updates and a dedicated NIH/OSP task force with appropriate expertise. The associations support proposed modifications to the Recombinant DNA Advisory Committee (RAC), with an expanded focus on emerging biotechnologies; however, they express concern over the absence of a central advisory entity for oversight at NIH, suggesting the need for formalized roles, accessible points of contact, and mechanisms for sharing information among IBCs engaged in multisite trials. Overall, the associations call for more detailed guidance, structured communication channels, and collaborative oversight structures to ensure continued effective governance and biosafety standards in the rapidly evolving field of genetic research.
