NOT-OD-26-101
NIH announcing a new policy designed to strengthen oversight of life sciences research that may pose significant risks to public health, public safety, economic security, or national security.
Issued pursuant to Executive Order 14292, the new policy establishes federal funding prohibitions and a risk-based oversight framework for high-risk life sciences research. The policy identifies two broad categories of research presenting the highest levels of concern: Dangerous Gain-of-Function (DGOF) research and International Research of Concern (IROC).
Importantly, this new policy replaces U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), which had previously established the federal framework for oversight of certain categories of biological research. The new policy therefore represents a significant change to the federal oversight framework for high-risk life sciences research, with DGOF and IROC requirements taking the place of the previous DURC-PEPP framework.
DGOF research is defined as research involving a biological agent that seeks, achieves, or has a substantial risk of achieving certain outcomes specified in the policy and that could result in significant negative societal consequences. IROC includes certain research conducted in countries of concern, research conducted outside the United States by individuals or institutions of concern, and research conducted in countries with inadequate oversight when the work could reasonably pose a threat to public health, safety, or economic or national security.
The policy explicitly prohibits federal support for DGOF research as defined under the new framework, as well as certain research conducted in or involving countries or entities of concern. It also establishes a broader risk-based oversight framework for other federally supported life sciences research, including additional restrictions involving international research conducted in locations where adequate research oversight may not be available.
NIH also states that research activities previously identified as potential DGOF research under NOT-OD-25-127 and NOT-OD-25-112 will remain paused until NIH-specific implementation requirements are established. Federal departments and agencies will develop and publish implementation guidance consistent with the new policy, and a single independent third-party review body will be established as part of the new oversight framework.
HHS and NIH will develop additional resources and issue implementation guidance addressing DGOF and IROC oversight requirements as the new federal framework is put into place. More information from UCSF will be coming.