New U.S. Policy Reshapes Oversight of High-Risk Life Sciences Research

Overview

The federal government has issued a new government-wide policy establishing funding prohibitions, review requirements, institutional responsibilities, and enforcement mechanisms for certain high-risk life sciences research.

The United States Government Policy for Stopping High-Risk Life Sciences Research, dated July 20, 2026, was developed in response to Executive Order 14292, Improving the Safety and Security of Biological Research. It replaces several previous oversight frameworks, including the 2024 federal policy governing dual use research of concern and pathogens with enhanced pandemic potential.

The new framework prohibits federal funding for research that meets the policy’s definition of dangerous gain-of-function research, establishes a review process for potential DGOF research, restricts certain international research activities, and creates new responsibilities for principal investigators, research institutions, and federal funding agencies.

NIH Director Dr. Jay Bhattacharya described the policy as a “paradigm shift” in federal oversight, citing its risk-based framework, enforcement measures, accountability provisions, international restrictions, and enhanced review requirements.

From Pathogen Lists to Consequence-Based Review

The policy replaces the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, including oversight previously established through federal policies issued in 2012, 2014, and 2017.

A central change is the move from a primarily list-based approach to a risk-based model. Instead of focusing only on designated pathogens or predefined research categories, the policy considers whether research involving a biological agent could produce significant negative societal consequences.

Those consequences may affect public health, agriculture, economic security, national security, the environment, or multiple systems at the same time. The policy’s definition also recognizes that an information hazard may contribute to significant negative societal consequences.

This broader framework means that determining whether research is covered requires an assessment of its intended or reasonably possible outcomes, not merely the identity of the biological agent involved.

Where Federal Funding Is Prohibited

The policy prohibits federal funding for research that meets its definition of dangerous gain-of-function research, whether the work would be conducted in the United States or abroad.

DGOF research is defined as research involving a biological agent that seeks, achieves, or carries a substantial risk of achieving one or more specified outcomes and could result in significant negative societal consequences.

Covered outcomes include:

• Enhancing the harmful consequences of a biological agent
• Disrupting a beneficial immune response or reducing the effectiveness of an immunization
• Conferring resistance to clinically or agriculturally useful interventions
• Facilitating evasion of detection methods
• Increasing stability, transmissibility, or ability to disseminate
• Altering host range or tropism
• Increasing the susceptibility of a human, animal, or plant population
• Generating or reconstituting an eradicated or extinct biological agent

The policy states that creating mirror organisms is included within the category of enhancing the harmful consequences of a biological agent.

The federal funding prohibition should not be interpreted as a universal statutory ban on all privately funded DGOF research. The policy notes that additional statutory action would be required to stop all DGOF research and DGOF funding by all U.S. entities. Executive Order 14292 separately directs the development of a strategy addressing dangerous gain-of-function research that does not receive federal funding.

How Potential DGOF Research Will Be Evaluated

The policy distinguishes prohibited DGOF research from potential DGOF research.

Potential DGOF research involves a biological agent and could result in one or more of the listed DGOF outcomes while also producing significant negative societal consequences.

Potential DGOF research is not categorically barred from federal support. Before it may be funded, however, the research must undergo institutional assessment and review by a single government-wide Independent Third-Party Review Body, or ITPRB.

The principal investigator and the institution’s review entity must complete a full risk-benefit assessment and a risk mitigation plan for a proposal being considered for federal funding. The ITPRB then provides a recommendation to the federal funding agency. The funding agency retains responsibility for the funding decision.

Importantly, a risk mitigation plan does not authorize DGOF research. Instead, researchers and institutions must use the plan to identify experimental modifications and implement safeguards that prevent prohibited DGOF research from being conducted.

Potential safeguards may include:

• Cybersecurity practices
• Restrictions on physical access to laboratories and research materials
• Controls involving transfers of technology and intellectual property
• Information-sharing management
• Disclosures to journal publishers before manuscript submission
• Training and oversight for laboratory personnel and collaborators

The ITPRB should, to the extent practicable, complete its standard review and provide a recommendation within 90 calendar days after receiving the review materials. The policy also permits expedited review in specified public health, agricultural emergency, and national security circumstances.

New Responsibilities for Principal Investigators

Principal investigators must evaluate proposed and ongoing life sciences research for DGOF, potential DGOF, and international research concerns.

Before submitting an application for federal funding, a PI must determine whether the proposed work meets the definition of DGOF or potential DGOF research and attest to that determination in writing.

If a proposed project may meet the potential DGOF definition, the PI must work with the institution’s review entity to complete an initial risk-benefit analysis before submission. If the project is being considered for federal funding, the PI and institutional review entity must prepare the full assessment and mitigation plan required for government review.

Applications must also identify key personnel and their institutional affiliations, including proposed foreign collaborators and research to be conducted outside the United States. Principal investigators must report any changes to research aims, key personnel, or participating institutions to the funding agency.
The policy also requires continuing evaluation after research begins.

If ongoing research develops the potential to meet the DGOF definition, the work should be halted while the PI and institutional review entity conduct the required assessment and inform the federal funding agency.

If the research may meet the definition of DGOF research, the PI must halt it immediately and notify the institutional contact, institutional review entity, and federal funding agency within 24 hours.

New Institutional Governance Requirements

The policy assigns new responsibilities to institutions receiving federal life sciences funding.

Its roles-and-responsibilities section specifically states that institutions proposing or supporting federally funded research with potential DGOF concerns must establish an Institutional Review Entity, or IRE, and designate an Institutional Contact for Dangerous Gain-of-Function Research, or ICDGOF.

The IRE must include at least five members with sufficient life sciences expertise to review potential DGOF research. Institutions are encouraged to include members of the local community and their Institutional Biosafety Committee. IRE members must not have conflicts of interest involving research under review.

The IRE’s responsibilities include:

• Conducting initial risk-benefit analyses with investigators
• Preparing full risk-benefit assessments and mitigation plans
• Communicating findings to federal funding agencies
• Overseeing approved mitigation plans and experimental modifications
• Reviewing mitigation plans at least annually
• Reporting modifications to the funding agency
• Maintaining records demonstrating compliance

The policy’s implementation section uses broader language. It states that, within 180 days, research institutions receiving any federal life sciences funding will establish an IRE and designate an ICDGOF.

Because these sections do not describe institutional scope in identical terms, agency-specific implementation guidance may need to clarify how the requirements apply across institutions and research portfolios.

Attestations, Certifications, and Institutional Accountability

Research institutions must attest that life sciences proposals submitted for federal funding have been evaluated for DGOF and international research concerns and have been correctly attested by the PI.

The ICDGOF must certify applications for federal funding to ensure that proposal materials are accurate and truthful. Federal agencies will monitor compliance under penalty of law.

Institutions receiving federal life sciences funding must also implement oversight mechanisms addressing non-federally funded potential DGOF and DGOF research and monitor for international research concerns.

Institutions must report non-federally funded potential DGOF and DGOF research annually to their primary federal life sciences funding agency. The policy states that agencies will treat this information as proprietary business information when appropriate and protect legitimate intellectual property interests.

These provisions do not establish a federal funding prohibition on all non-federally supported research. They establish oversight and reporting responsibilities for federally funded institutions while the government develops a broader strategy under Executive Order 14292 for research conducted without federal support.

A Government-Wide Review Body and Audit Process

Federal funding agencies must establish a single United States Government ITPRB.

The body will include officials and subject-matter experts in areas including molecular biology, microbiology, clinical medicine, biosafety, biosecurity, cybersecurity, medical countermeasure development, ethics, public health, agriculture, law enforcement, national security, and biodefense.

The ITPRB will review potential DGOF projects being considered for federal funding and provide recommendations based on:

• The full risk-benefit assessment
• The project’s risk mitigation plan
• Proposed experimental modifications
• Procedures for preventing DGOF research
• Other information relevant to the funding decision

The ITPRB will also issue annual public reports on its recommendations while avoiding disclosure of information that could compromise national security, research safety and security, confidential business information, personal information, or legitimate intellectual property interests.

Federal funding agencies must maintain attestation records for audit by the Office of Science and Technology Policy and the Office of Management and Budget. The ITPRB may randomly review and audit up to 25 percent of negative attestations annually.

New Restrictions on International Research

The policy establishes a category called International Research of Concern, or IROC.

Federal funding agencies may not fund life sciences research involving an entity of concern. This includes covered research conducted in a country of concern or research conducted outside the United States by an institution or individual identified as an entity of concern.

The policy directs designated federal officials to establish, maintain, and publish, as appropriate, lists of entities of concern within 120 days. Those lists are to be reviewed and updated at least annually.

Federal agencies must evaluate the names and affiliations of key personnel, including updates made during a project, to determine whether proposed or ongoing research involves an individual or institution of concern.

Other international life sciences research is not categorically prohibited. It may be considered for funding following a risk-based assessment of the potential threat and the institution’s ability to provide oversight consistent with U.S. biosafety and biosecurity standards and policies.

These provisions do not prohibit international scientific collaboration as a category. They establish funding restrictions and review requirements based on the location of the work, participating entities, potential consequences, and adequacy of oversight.

How the Policy Treats Computational and AI-Enabled Research

The policy also addresses computational, or in silico, research.

Purely computational research, including the development of models or software and the computational design of novel biological agents, is not prohibited unless it involves an entity of concern.

However, the policy applies when a proposal includes plans to create or modify a biological agent resulting from in silico research and the proposed activity would meet the DGOF or potential DGOF definitions.

OSTP will also convene an interagency group to monitor advances at the intersection of biological sciences and artificial intelligence, including in silico life sciences research.

The policy does not broadly prohibit AI-enabled biological research. Its requirements apply when the planned creation or modification of a biological agent falls within a covered category or when the work involves an entity of concern.

What the Policy Does Not Prohibit

The policy does not categorically prohibit:

• Basic or applied life sciences research
• International scientific collaboration
• Development of vaccines, therapeutics, diagnostics, or other essential medical products
• Development of medical countermeasures against bioterrorism or biological weapons
• Research intended to improve public health, agriculture, biotechnology, biomanufacturing, biosafety, or laboratory biosecurity

Those activities remain permissible when they do not meet a prohibited category and otherwise comply with applicable oversight, funding, biosafety, biosecurity, statutory, and regulatory requirements.

Implementation Timeline

The policy establishes several implementation periods measured from its July 20, 2026 issuance.

Within 90 Days – Relevant federal agencies and departments must establish the single ITPRB. The body must develop its charter, procedures, and review criteria.

Within 120 Days – Relevant federal funding agencies must:

• Issue DGOF and IROC implementation guidance
• Define roles, responsibilities, and review standards
• Address implementation questions from research institutions
• Modify review processes, funding mechanisms, and terms and conditions as necessary

Designated federal officials must also establish, maintain, and publish, as appropriate, the lists of entities of concern. The Executive Office of the President will coordinate agency plans and provide final clearance.

Within 180 Days – The policy states that federally funded research institutions must:

• Establish an IRE
• Designate an ICDGOF
• Implement annual educational training
• Maintain records of individuals accepting and complying with the policy
• Establish policies for identifying and addressing DGOF and potential DGOF research

Within the same period, relevant federal departments and agencies are to ensure that life sciences research contracts, grants, cooperative agreements, and Other Transactions include specified compliance and enforcement terms, consistent with applicable law and regulation.

Until agency implementation guidance and the policy’s review mechanisms are established, the suspension of federally funded potential DGOF research required by Executive Order 14292 remains in effect.

Potential Consequences of Noncompliance

The policy directs federal agencies to incorporate its requirements into the terms and conditions of federal life sciences funding.

Failure to comply may lead to:

• Immediate revocation of ongoing federal funding
• Up to five years of ineligibility for relevant federal life sciences funding
• Suspension, termination, or withholding of support
• Additional penalties consistent with applicable federal law and regulation

These consequences are not described as automatic in every case. The policy states that recipients, employers, or institutions found in violation may be subject to them.

The policy also specifically identifies deliberate false negative attestations as conduct that may result in revocation of federal research funding and a period of funding ineligibility.

How Institutions Can Prepare

The policy establishes the government-wide framework, but agency-specific procedures and implementation details are still to come.

Institutions may want to determine how responsibilities under the policy relate to existing functions involving:

• Institutional biosafety
• Biosecurity
• Research security
• Sponsored programs
• Proposal review
• International research
• Information security
• Legal and compliance oversight
• Research communications and publication review
• Training administration and recordkeeping

This is an implementation consideration rather than a prescribed organizational structure. The policy defines required functions, but it does not direct institutions to assign those functions to particular existing offices.

Institutions should identify which requirements come directly from the policy and which procedures federal agencies may further define through implementation guidance, funding terms, and applicable regulations.

Why the Policy Is Significant

The policy consolidates several prior federal oversight frameworks into a government-wide, risk-based system involving funding prohibitions, attestations, institutional review, independent government-wide review, audits, transparency measures, and potential enforcement.

NIH has described the new framework as a “paradigm shift” in federal oversight and has advised researchers and institutions involved in life sciences work to review the policy in detail.

Its practical effect will depend partly on the implementation guidance issued by individual funding agencies. Still, the policy itself establishes new federal expectations for evaluating research risk, documenting institutional review, certifying funding applications, monitoring ongoing work, and responding when research meets or may meet a covered definition.