Issue: ORN-2026-42

United States Government (USG) Policy for Stopping High-Risk Life Sciences Research

The U.S. Government Policy for Stopping High-Risk Life Sciences Research, issued in July 2026, fundamentally shifts federal oversight of biological research from risk mitigation to outright prohibition of designated high-risk activities, expanding the scope from previous policies to include even computational research. Under this new policy, federally funded institutions must identify, review, and, where necessary, halt proposed and ongoing research that meets broad definitions for Dangerous Gain-of-Function Research (DGOFR), potential DGOFR, or International Research of Concern (IROC).  Federal funding is categorically prohibited for DGOFR and certain IROC, and potential DGOFR is subject to stringent third-party review.  Institutions and principal investigators now bear primary responsibility for compliance, and are required to implement new internal review mechanisms, annual reporting, and certification processes, with noncompliance resulting in severe penalties, including funding revocation and multi-year federal ineligibility, all on an accelerated implementation timeline culminating in full compliance by January 2027, with a retroactive lookback to July 2026.

Federal funding agencies (NSF, NIH, etc.) must release their operational and compliance guidance by November 17, 2026.  Specific implementation details will not be available until after the guidance is made public.

NIH Notice: NOT-OD-26-101: USG Policy for Stopping High-Risk Life Sciences Research

The Federal Government is issuing a new United States Government (USG) Policy for Stopping High-Risk Life Sciences Research pursuant to Section 4 of Executive Order 14292. NIH is working with the Administration and its Interagency partners to fully implement this new USG Policy, which includes an explicit prohibition on dangerous gain-of-function research. All research activities identified as potential dangerous gain-of-function research per NOT-OD-25-127 and NOT-OD-25-112 remain paused until NIH specific implementation requirements are established. 

The USG Policy for Stopping High-Risk Life Sciences Research defines areas of life sciences research posing the greatest risk to our Nation's security, implements federal funding prohibitions, and establishes a robust framework for mitigating risk and ensuring compliance. Two broad categories of life sciences posing the highest risk are identified:

• Dangerous gain-of-function (DGOF) research. Research with a biological agent that seeks, achieves, or has a substantial risk of achieving one or more of the outcomes listed in the Policy and could result in significant negative societal consequences.

• International research of concern (IROC). Research conducted in a country of concern or outside of the United States by individuals or institutions of concern; or research that could reasonably pose a threat to public health, public safety, and economic or national security conducted in a country with inadequate oversight.

The new Policy explicitly prohibits any federal support for DGOF research, as defined therein, as well as research conducted in or involving countries or entities of concern. It also establishes a comprehensive, risk-based oversight framework for all other life sciences research, including new restrictions on international research conducted in countries lacking adequate oversight. Actions required of investigators, research institutions, and federal funding agencies are backed by strong enforcement, accountability, and transparency measures.