New government-wide requirements create significant review, certification, monitoring, reporting, and enforcement obligations for federally funded life sciences research.
On July 28, 2026, the National Institutes of Health announced the release of the United States Government Policy for Stopping High-Risk Life Sciences Research, a government-wide framework dated July 20, 2026, designed to address what the government views as areas of research posing the “greatest risk” to national security. The policy prohibits federal funding for research classified as “dangerous gain-of-function research,” establishes new restrictions for certain international life sciences research, and imposes expanded review, certification, monitoring, reporting, and enforcement obligations on researchers and institutions receiving federal life sciences funding.
The policy represents a significant change in federal oversight. It replaces the 2024 federal policy governing dual-use research of concern and pathogens with enhanced pandemic potential, along with earlier DURC and P3CO policies, and expressly shifts from a principally list-based model to a broader, risk-based framework. The new requirements apply not only to research involving specified pathogens, but potentially to research involving any biological agent that could produce designated high-risk outcomes and significant negative societal consequences.
Although agencies have up to 120 days to issue implementation guidance, research institutions should begin preparing now. Institutions receiving federal life sciences funding will be expected to evaluate all proposed and ongoing life sciences research for covered risks, establish a new institutional review structure, designate a responsible institutional official, train researchers annually, revise proposal and award-management procedures, and monitor certain non-federally funded research.
Key Takeaways
• Federal funding for dangerous gain-of-function research (DGOF) is prohibited. The prohibition extends to research conducted domestically or internationally when the research seeks, achieves, or has a substantial risk of achieving specified outcomes with potentially significant negative societal consequences.
• Potential DGOF research may remain eligible for funding, but only after enhanced institutional and federal review, including risk-benefit analysis, mitigation planning, and review by a government-wide independent third-party body.
• The policy applies broadly across the federally funded research enterprise, including principal investigators, research institutions, and federal agencies conducting, funding, or supporting life sciences research.
• Institutions must evaluate all proposed and ongoing life sciences research—not merely research already believed to be high risk—against the DGOF and international-research criteria.
• International collaborations will receive substantially greater scrutiny, including prohibitions involving designated countries, institutions, or individuals of concern and risk-based review of other foreign research.
• Certifications and compliance representations carry significant enforcement risk, including funding revocation, suspension or termination, withholding of support, up to five years of ineligibility, and potential False Claims Act exposure.
What Research Is Covered?
Dangerous Gain-of-Function Research
Dangerous gain-of-function, or DGOF, research is defined as research involving a biological agent that seeks, achieves, or has a substantial risk of achieving one or more specified outcomes and could result in significant negative societal consequences. The listed outcomes include enhancing the harmful consequences of a biological agent; disrupting beneficial immune responses or immunization effectiveness; conferring resistance to useful interventions or facilitating evasion of detection; increasing stability, transmissibility, or dissemination; altering host range or tropism; increasing population susceptibility; and generating or reconstructing an eradicated or extinct biological agent.
Federally funded DGOF research is prohibited. The policy separately defines potential DGOF research as research that could potentially produce one or more listed outcomes and could result in significant negative societal consequences. Potential DGOF research is not automatically prohibited, but may receive federal funding only after review and a recommendation by the government’s independent third-party review body confirming that the research does not meet the DGOF definition.
The distinction between DGOF and potential DGOF is therefore critical. Institutions will need defensible procedures for determining whether a project presents a substantial risk of producing a covered outcome or merely has the potential to do so. Neither term is reducible to a simple pathogen list, and the policy defines potential by reference to what relevant scientific experts would expect to occur with a non-trivial likelihood.
International Research of Concern
The policy’s second major category, international research of concern, or IROC, addresses two forms of international activity.
First, federal agencies may not fund life sciences research involving an entity of concern. This includes research conducted in a country of concern and research performed outside the United States by a designated institution or individual of concern. The Director of National Intelligence and the Secretaries of State, Agriculture, and Health and Human Services are directed to establish and publish appropriate lists within 120 days and review them at least annually.
Second, other international research that could reasonably threaten public health, public safety, economic security, or national security may be funded only after a risk-based assessment. Agencies must determine whether the foreign institution meets, exceeds, or complies with U.S. biosafety and biosecurity oversight standards and whether it can provide adequate oversight.
These provisions will likely affect not only direct foreign subawards but also foreign collaborators, foreign research sites, key personnel, material transfers, and projects whose personnel or institutional arrangements change after award.
A Broader Framework Than the Prior DURC and P3CO Policies
The policy replaces the 2024 federal oversight policy for dual-use research of concern and pathogens with enhanced pandemic potential, the 2012 and 2014 DURC policies, and the 2017 P3CO guidance. Existing legal regimes—including the Federal Select Agent Program and export-control regulations—remain separately applicable.
The most important conceptual change is the move away from relying primarily on specified agents and experimental categories. The policy instead asks whether research involving a biological agent could produce designated outcomes and significant negative societal consequences. Life sciences research is defined broadly to include biotechnology, genomics, proteomics, bioinformatics, pharmaceutical and biomedical research, and funding for research capacity and infrastructure, including BSL-3 and BSL-4 laboratory construction or renovation.
The policy also reaches planned wet-laboratory work developed through computational methods. Purely computational research is generally not prohibited unless it involves an entity of concern, but a proposal to create or modify a biological agent that would meet the DGOF or potential-DGOF definition remains covered even when the proposal results from in silico research. The Office of Science and Technology Policy will convene an interagency group to monitor developments at the intersection of artificial intelligence and biological sciences.
New Responsibilities for Principal Investigators
Before submitting a proposal for federal life sciences funding, a principal investigator must determine whether the proposed research constitutes DGOF or potential DGOF research and attest in writing to that determination. The policy requires continuous evaluation rather than a one-time assessment at proposal submission.
When a PI determines that a project may constitute DGOF or potential DGOF research, the PI and the institution’s review entity must complete an initial risk-benefit analysis before submission. If the agency considers the proposal for funding, the PI and institution must prepare a full risk-benefit assessment and risk-mitigation plan for federal review.
The mitigation plan may address experimental design, cybersecurity, physical access to laboratories and materials, technology and intellectual-property transfers, publication disclosures, information sharing, and personnel training and oversight. A mitigation plan is intended to ensure that DGOF research will not occur; it is not a mechanism for authorizing research that meets the prohibited DGOF definition.
PIs must identify the names and institutional affiliations of key personnel, including proposed foreign collaborators and participants in work conducted abroad. Changes in research aims, key personnel, or institutional arrangements must be reported to the funding agency, and key personnel must disclose professional research-and-development support from non-federal sources, including material and in-kind support.
For funded research not previously reviewed by the government-wide review body, the PI must halt the work and notify the institution and funding agency if the project later meets—or has the potential to meet—the potential-DGOF definition. For reviewed projects, the institutional review entity must conduct at least annual evaluations. Research must be stopped immediately, with notice within 24 hours, if it may meet the DGOF definition.
New Institutional Governance Requirements
Institutions proposing or supporting federally funded potential-DGOF research must designate an Institutional Contact for Dangerous Gain-of-Function Research, or ICDGOF. This individual will serve as the institution’s internal policy resource and liaison with federal agencies.
Covered institutions must also establish an Institutional Review Entity, or IRE, consisting of at least five members with sufficient life-sciences expertise to assess potential-DGOF research. Members must be free from relevant conflicts of interest, and institutions are encouraged to include representatives from the local community and the institutional biosafety committee.
The IRE’s responsibilities include performing initial risk-benefit analyses; helping PIs prepare full assessments and mitigation plans; communicating findings to federal agencies; overseeing funded projects reviewed by the federal body; evaluating mitigation plans at least annually; seeking agency approval for modifications; and maintaining records sufficient to demonstrate compliance.
Institutions must certify that federal funding applications are accurate and truthful and attest that each proposal has been evaluated for DGOF and IROC issues and correctly classified by the PI. Institutions receiving federal life sciences funding must also implement mechanisms to identify non-federally funded potential-DGOF and DGOF research and monitor for international-research concerns. They must report non-federally funded potential-DGOF and DGOF research annually to their primary federal life sciences funding agency.
This institution-wide reach is among the policy’s most consequential features. Even when a particular project is privately funded, the existence of federal life sciences funding elsewhere within the institution may trigger identification, oversight, and reporting duties.
Federal Review and Award Administration
Federal agencies must assess each life sciences proposal being considered for funding and review PI attestations. Agencies must identify covered research not properly classified by the PI or institution and provide positive and negative attestations concerning potential-DGOF and IROC proposals to the Office of Management and Budget and the independent review body.
A single government-wide Independent Third-Party Review Body, or ITPRB, must be established within 90 days. The body will review potential-DGOF proposals and generally should make a recommendation within 90 calendar days after receiving the required review materials. It may also audit up to 25% of negative attestations annually.
The policy provides an expedited process for research needed to respond to a declared public-health or agricultural emergency or research critical to national security. Expedited review procedures are to permit review within 30 days, if not sooner, but do not displace other applicable statutes, regulations, or policies.
Research approved after ITPRB review will be governed by award-specific terms and conditions. The PI and institution must accept those conditions and implement the approved mitigation plan, with continuing institutional and federal oversight.
Enforcement and Potential False Claims Act Exposure
The policy directs agencies to incorporate compliance requirements into contracts, grants, cooperative agreements, and other awards. Within 180 days, agencies are expected to make recipients’ compliance certifications material to federal payment decisions for purposes of 31 U.S.C. § 3729(b)(4), a provision of the False Claims Act.
Potential consequences for noncompliance include immediate revocation of ongoing federal funding; suspension, termination, or withholding of support; up to five years of ineligibility for federal life sciences funding; and other penalties available under existing federal law and regulations.
The policy specifically identifies deliberately false negative attestations as conduct that may lead to revocation and ineligibility. Institutions should therefore treat DGOF and IROC classifications as formal compliance determinations supported by scientific analysis, documentation, internal review, and escalation procedures—not as routine administrative checkboxes.
Implementation Timeline
The operative deadlines run from the policy’s July 20, 2026 issuance date:
| Deadline | Required action |
| Within 90 days — October 18, 2026 | Federal agencies and departments are to establish the single ITPRB and its charter, procedures, and review criteria. |
| Within 120 days — November 17, 2026 | Relevant agencies are to issue implementation guidance; responsible officials are to establish and publish appropriate lists of entities of concern. |
| Within 180 days — January 16, 2027 | Federally funded research institutions are to establish an IRE, designate an ICDGOF, implement annual training and institutional policies, and maintain training records. Agencies are expected to incorporate verification, compliance, and enforcement provisions into life sciences awards. |
Executive Order 14292’s existing suspension of federally funded potential-DGOF research remains in effect until agencies issue implementation guidance and establish the review mechanisms required by the policy.
Practical Considerations for Research Institutions
Proposal Intake Will Need to Begin Earlier
The required scientific and institutional review cannot reliably occur at the final stage of grant submission. Sponsored-programs offices may need to identify potentially covered projects during pre-proposal development, particularly where research involves engineering biological agents, increasing transmission or stability, altering host range, reconstructing agents, or using foreign laboratories or collaborators.
Existing Committees May Not Fully Satisfy the New Requirements
Institutions may be able to draw on institutional biosafety committees, DURC committees, research-security offices, export-control personnel, and compliance functions. Nevertheless, the policy prescribes specific requirements for the IRE, including size, expertise, conflict management, recordkeeping, and responsibilities. Institutions should not assume that an existing committee automatically satisfies those requirements.
International Research Reviews Should Be Integrated
IROC review overlaps with, but is not identical to, export controls, foreign-influence disclosure, research security, sanctions, and subrecipient monitoring. Institutions should consider a coordinated process involving research compliance, sponsored programs, export controls, legal counsel, information security, procurement, and international-program personnel.
Private Funding May Not Remove Institutional Obligations
Institutions receiving federal life sciences funding must implement mechanisms addressing covered non-federally funded research and annually report identified potential-DGOF and DGOF research to their primary federal funding agency. The policy therefore may affect philanthropic, industry-sponsored, institutionally funded, and other privately funded research conducted within federally funded organizations.
Documentation Will Be Essential
Given the contemplated audits, award certifications, potential funding consequences, and False Claims Act implications, institutions should document the scientific basis for classifications, committee deliberations, mitigation decisions, disclosures, personnel changes, foreign-site assessments, training, monitoring, and escalation of changed circumstances.
What Organizations Should Do Now
1. Establish an implementation team. Include scientific leadership, institutional biosafety, sponsored programs, research compliance, research security, export controls, information security, legal, audit, and grants-management personnel.
2. Inventory potentially affected research. Review proposed and ongoing work involving biological agents, including federally and non-federally funded projects, international collaborations, foreign subawards, foreign sites, BSL-3 and BSL-4 infrastructure, and research developed through computational or AI-assisted methods.
3. Map existing governance to the new model. Determine whether existing committees, policies, systems, and personnel can support the IRE and ICDGOF functions and identify any governance gaps.
4. Develop an interim screening process. Create risk-based intake questions that can be used before agencies issue final implementation guidance. Any interim process should expressly remain subject to revision.
5. Review international arrangements. Identify research conducted abroad, foreign collaborators and key personnel, foreign subrecipients, material transfers, and relationships that may require additional diligence once entity-of-concern lists are released.
6. Revise proposal certifications and escalation procedures. Establish documented processes for PI attestations, institutional confirmation, changed circumstances, research holds, and 24-hour reporting when work may meet the DGOF definition.
7. Prepare training and communications. The policy requires annual training, and institutions may need role-specific instruction for PIs, laboratory staff, committee members, research administrators, and international-program personnel.
8. Review award-compliance controls. Determine how new terms and conditions will be incorporated into subawards, contracts, collaboration agreements, laboratory procedures, publication processes, and internal audit plans.
Important Open Questions
How will agencies distinguish DGOF from potential DGOF? The line between a substantial risk of achieving an outcome and the potential to achieve it will often require scientific judgment. Consistent review standards will be essential.
How broadly must institutions evaluate ongoing research? The policy requires all proposed and ongoing life sciences research at federally funded institutions to be evaluated, but it does not specify the required timing, documentation, or depth of the initial institution-wide screening.
What constitutes an adequate IROC risk assessment? Agencies must assess foreign oversight using a risk-based method, but the policy does not yet establish uniform criteria, acceptable evidence, or procedures for addressing deficiencies.
How will non-federally funded research be reported? Additional guidance is needed concerning report content, confidentiality, privilege, proprietary information, and coordination where an institution receives funding from multiple agencies.
How will the policy apply to institutional affiliates and complex organizations? Further clarification may be necessary for health systems, separately incorporated research foundations, joint ventures, contract research organizations, affiliated hospitals, and multicampus institutions.
How will agencies handle pending proposals and existing awards? The policy leaves open how new requirements will be applied to applications already submitted, awards already issued, renewal applications, supplements, and ongoing work that was compliant under the prior framework.
What is the precise reach of the False Claims Act language? Award-specific implementation will determine which certifications, attestations, invoices, progress reports, and payment requests carry express or implied compliance representations.
Conclusion
The new policy substantially expands federal scrutiny of high-risk biological research and places primary screening and monitoring responsibilities on both individual researchers and their institutions. Although important details will depend on forthcoming agency guidance, the policy establishes clear near-term expectations: institutions must evaluate life sciences research broadly, create new governance and certification processes, strengthen oversight of international activities, and prepare for meaningful funding and enforcement consequences.
Organizations that receive federal life sciences support should begin implementation planning before the formal deadlines rather than waiting for agency-specific guidance. Early preparation will be particularly important for institutions with large research portfolios, decentralized proposal processes, significant foreign collaborations, or privately funded biological research that may fall within the new risk categories.
Primary Sources
U.S. Government Policy for Stopping High-Risk Life Sciences Research (July 2026)
NIH announcement regarding release of the policy
This client alert is intended for general informational purposes and does not constitute legal advice. Readers should consult counsel regarding the application of the policy to specific research activities, awards, collaborations, or institutional structures.
