New Government-wide Policy on High-Risk Life Science Research

By: Galen Cobb
Wednesday, August 12, 2026
On July 28, the White House released the U.S. Government Policy for Stopping High-Risk Life Sciences Research, a government-wide framework that restricts two categories of research: Dangerous Gain-of-Function (DGOF) research and International Research of Concern (IROC). The policy, issued pursuant to Executive Order 14292 on Improving the Safety and Security of Biological Research, replaces prior federal oversight frameworks built around a limited list of regulated pathogens with a risk-based approach centered on the potential consequences of research. Both the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) issued statements welcoming the policy's release, and NIH issued a companion notice, NOT-OD-26-101, the same day.

DGOF research is defined as work with a biological agent or toxin that “could result in significant negative societal consequences” and seeks, achieves, or carries a substantial risk of achieving one or more of seven outcomes: enhancing the harmful consequences of the agent or toxin; disrupting beneficial immune response or vaccine effectiveness against it; conferring resistance to clinically or agriculturally useful prophylactics or therapeutics, or the ability to evade detection; increasing stability, transmissibility, or dissemination; altering host range or tropism; increasing susceptibility of a human host population; or generating or reconstituting an eradicated or extinct agent or toxin. Federal support for DGOF research meeting these criteria is now explicitly prohibited, in the United States and through foreign collaboration.

The policy also distinguishes potential DGOF research, which “could potentially result in” one of the seven outcomes listed above. Institutions and principal investigators (PIs) bear initial responsibility for identifying potential DGOF research. PIs, working with their institution's Institutional Review Entity (IRE), must conduct a risk-benefit assessment and develop a risk-mitigation plan before that research can proceed to further review.
The IROC policy restricts research conducted with foreign entities of concern, prohibiting collaboration on covered research with such entities altogether. It further restricts collaboration with entities in countries that do not meet U.S. standards of biosafety and biosecurity oversight, as determined by the head of the relevant funding agency.

The policy establishes new institutional and oversight obligations. Institutions receiving federal life sciences funding must stand up an IRE and designate an Institutional Contact responsible for DGOF-related matters. Both institutions and PIs will be required to submit attestations affirming that proposed research does not meet the definition of DGOF. Oversight at the federal level will run through a new Independent Third-Party Review Board (ITPRB), a single review body serving all federal agencies, with agencies submitting annual reports to the Office of Science and Technology Policy, the Assistant to the President for National Security Affairs, and the Office of Management and Budget.

Federal departments and agencies have 120 days from the policy's release to publish implementation guidance and 90 days to establish the ITPRB. Until agencies finalize their implementation guidance and review mechanisms, research previously flagged as potential DGOF under NIH's June 2025 pause (NOT-OD-25-127) remains suspended.

Institutions and investigators engaged in research are encouraged to review the full policy text, the HHS announcement, and the NIH companion notice linked above.