Key Dates

Related Announcements

• June 18, 2025 - Implementation Update: Terminating or Suspending Dangerous Gain-of-Function Research in Accordance with the Executive Order on Improving the Safety and Security of Biological Research. See NOT-OD-25-127
• May 7, 2025 - Implementation Update: Improving the Safety and Security of Biological Research. See NOT-OD-25-112

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

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. 

Implementation Guidance

Federal departments and agencies have 120 days to develop and publish implementation guidance consistent with this Policy and 90 days to establish a single independent third party review body. As soon as departments and agencies have promulgated implementation guidance and the review mechanisms defined in this Policy have been established, the suspension of federally funded DGOF, per section 3(b) of the EO, will be lifted and projects flagged as potential DGOF research can be processed as described in the Policy. 

All research institutions are expected to fully review and comply with this Policy. Section 4 outlines specific requirements for institutions receiving federal life sciences funding. HHS and NIH will develop resources and issue DGOF and IROC oversight implementation guidance to research institutions within 120 days per the Policy.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy 

[email protected]