NIH has revised the NIH Guidelines to specify biosafety practices for research involving gene drive modified organisms (GDMOs) in contained research settings.  These revisions include: 

Specifying the minimum containment requirement for research involving GDMOs;  

Articulating considerations for risk assessment and additional responsibilities for Institutional Biosafety Committees (IBCs) and Biosafety Officers 

NIH previously published a Request for Information (RFI) in August 2023 seeking public input on proposed revisions. The proposed revisions were informed by recommendations contained in the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) report, Gene Drives in Biomedical Research.   

The revised version of the NIH Guidelines is available at https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm. To assist IBCs, biosafety professionals, and investigators with implementation of these changes, OSP has developed a reference document to help ensure the safe and responsible conduct of research involving GDMOs in contained research settings.   Questions may be sent to SciencePolicy@od.nih.gov.  Also, please consider following us on X @NIH_OSP.