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U.S. Government Policy for Stopping High-Risk Life Sciences Research Fact Sheet

S3: Science Safety Security

At A Glance

The United States Government Policy for Stopping High-Risk Life Sciences Research establishes a comprehensive framework to stop Dangerous Gain-of-Function (DGOF) research and strengthen oversight of high-risk international life sciences research to protect public health, economic security, and national security.

What the Policy Covers

  1. Prohibits federal funding for DGOF under all circumstances and sets parameters for funding high-risk international research.

  2. Strengthens compliance and oversight through accountability, monitoring, and enforcement provisions.

  3. Requires regular reporting to support transparency and public trust while safeguarding national security and intellectual property.

  4. Supports legitimate research and is not intended to impede basic or applied research, medical countermeasure development, or biotechnology innovation.

Key Policy Changes

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Unified risk-based approach. 
Replaces the 2024 U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with 
Enhanced Pandemic Potential.
 

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Independent review.
Creates an Independent Third-Party Review Body (ITPRB) to provide expert review of potential DGOF research.

 

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Stronger accountability.
Requires attestations, disclosures, monitoring, annual reporting, audits, funding terms and conditions, 
and enforcement for noncompliance.
 

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International safeguards.
Prohibits federal funding of life sciences research involving entities of concern. Other international life sciences
research must meet, exceed, or comply with U.S. biosafety and biosecurity oversight standards and policies.
 

Who the Policy Affects

  • Research institutions receiving federal life sciences funding, including academic and private-sector institutions.

  • Principal Investigators conducting or applying for federally funded life sciences research.

  • Institutional Contacts for DGOF Research (ICDGOFs), a position established by the policy.

  • Federal agency leadership and staff conducting or funding life sciences research.

  • Institutions conducting non-federally funded DGOF or potential DGOF research, which may have oversight and reporting responsibilities or implications for future Federal funding eligibility.

What Researchers Should Do Now

  • Review the final policy.

  • Monitor your primary funding agency for implementation guidance and resources.

  • Prepare for institution-level requirements, including designated contacts, review processes, training, and compliance procedures.

Implementation Timeline

  1. 90 DAYS

    Federal agencies and departments establish the ITPRB.

  2. 120 DAYS

    Funding agencies publish DGOF/International Research of Concern implementation guidance and resources; designated officials publish the entities-of-concern list.

  3. 180 DAYS

    Federally funded institutions establish an Institutional Review Entity, designate an ICDGOF, and implement annual training and institutional procedures; funding agencies incorporate compliance provisions into funding instruments.

FOR MORE INFORMATION

Consult the full policy and the soon-to-be-released implementation guidance issued by the relevant federal funding agency. This fact sheet is a plain-language summary and does not replace the policy or agency-specific requirements.

Questions? Contact: LifeSciOversight@hhs.gov
 

Download the Fact Sheet (PDF)