TL;DR: On July 28, 2026, NIH, HHS, and OSTP announced the release of the U.S. Government Policy for Stopping High-Risk Life Sciences Research (framework dated July 20, 2026), issued under Section 4 of Executive Order 14292. The new policy formally replaces the 2024 USG Policy for Oversight of DURC and Pathogens with Enhanced Pandemic Potential (DURC/PEPP) — which had itself unified the 2014 DURC policy and the 2017 P3CO Framework — with a risk-based regime built around two new categories: prohibited “dangerous gain-of-function” (DGOF) research and new restrictions on “international research of concern” (IROC). It adds certification, monitoring, reporting, and stop-work obligations for institutions, backed by enforcement up to five years of federal ineligibility, with agency implementation guidance due within 120 days.
What Changed: A Risk-Based Framework Replaces DURC/PEPP
The policy is NIH’s implementing notice for a government-wide directive that traces back to EO 14292 (signed May 5, 2025), which paused federal funding for dangerous gain-of-function research and rescinded the 2024 DURC/PEPP policy while OSTP worked out a replacement. NIH published its own notice, NOT-OD-26-101, alongside a joint HHS statement. Where the 2024 DURC/PEPP policy worked primarily from an enumerated list of agents and experiment categories, the new policy shifts to a broader, risk-based test: does the research seek, achieve, or carry a substantial risk of achieving specified dangerous outcomes, regardless of whether the agent involved appears on a pre-set list.
Two Categories of Covered Research
Dangerous Gain-of-Function (DGOF) Research
The policy defines DGOF research as research involving a biological agent that seeks, achieves, or has a substantial risk of achieving one or more specified outcomes, where the result could produce significant negative societal consequences. The outcomes it lists include enhancing the harmful consequences of an agent, disrupting host immune response, conferring resistance to medical or public health countermeasures, increasing transmissibility, altering host range, and generating or reconstructing an eradicated or extinct biological agent. This is narrower in one sense than a blanket ban on gain-of-function technique — the broad category of routine, low-risk gain-of-function work used throughout ordinary laboratory research is not what the policy targets — but broader in another, because the test is now outcome-based rather than tied to a closed list of covered agents. See CASRAI’s guide, What Is Gain-of-Function Research?, for the underlying science and how DGOF relates to the wider Dual Use Research of Concern (DURC) category.
International Research of Concern (IROC)
The second new category restricts federal funding for research conducted in a country of concern, or performed outside the United States by an institution or individual the government designates as one of concern. Other international life sciences research — work that doesn’t fall into that designated-entity category outright — is instead subject to a risk-based assessment of whether the foreign institution meets U.S. biosafety standards and can provide adequate oversight. Agencies are directed to establish and publish lists of entities of concern as part of their implementation guidance.
New Institutional Obligations
The policy adds several duties that did not exist under the 2024 DURC/PEPP framework:
- Certification and attestation. Institutions must certify that federal funding applications are accurate and truthful, and attest that each proposal has been evaluated for DGOF and IROC issues; principal investigators are expected to provide written attestations on research classification before proposal submission.
- Monitoring and annual reporting. Institutions must implement mechanisms to identify potential-DGOF and DGOF research that is not federally funded — a gap the funding-agreement-based 2024 framework had no mechanism to reach — and report it annually to their primary federal life sciences funding agency.
- Immediate stop-work and 24-hour notice. If ongoing research may meet the DGOF definition, the policy requires that work stop immediately, with notice to the funding agency within 24 hours.
- Institutional Review Entity (IRE) evaluations. The institution’s IRE — often the same body designated under the prior DURC policy, sometimes the Institutional Biosafety Committee (IBC) — must conduct at least annual evaluations of funded projects against the new DGOF/IROC criteria.
Enforcement and Liability Exposure
Noncompliance carries real consequences under the new policy: immediate revocation of ongoing federal funding; suspension, termination, or withholding of support; and up to five years of ineligibility for federal life sciences funding. Separately, within 180 days agencies are directed to make compliance certifications material to federal payments under the False Claims Act (31 U.S.C. § 3729(b)(4)) — which means an inaccurate DGOF/IROC certification could expose an institution to False Claims Act liability, not just a funding action, once that provision takes effect.
Timeline: The Next 120 Days
Federal agencies have 120 days from the policy’s release — by roughly mid-November 2026 — to issue their own implementation guidance and to establish and publish agency-specific lists of entities of concern under the IROC provisions. Per NIH, research activities already identified as potential DGOF research under its earlier notices, NOT-OD-25-127 and NOT-OD-25-112, remain paused until NIH publishes agency-specific implementation requirements under the new policy. Institutions should not assume agency guidance mirrors the government-wide policy text exactly once it lands — each funding agency is expected to publish its own version.
What Research Administrators and Biosafety Officers Should Do Now
- Inventory active and pending life sciences awards against the DGOF outcome list above, in coordination with the IBC/IRE and sponsored-programs office, rather than waiting for agency-specific guidance to start the review.
- Map international collaborations against the IROC provisions — identify any collaborator, subrecipient, or performance site located outside the United States before agency entity-of-concern lists are published, since the underlying restriction applies from the policy text, not only once a list exists.
- Stand up (or confirm) a non-federally-funded research monitoring process, since the annual reporting duty for potential-DGOF work explicitly extends beyond federally funded projects.
- Confirm the IRE’s annual-evaluation cadence and 24-hour stop-work notification pathway are actually operational, not just documented in policy — this is a new procedural requirement, not a restatement of existing IBC biosafety review.
- Loop in institutional counsel on the certification language going into future proposals, given the False Claims Act materiality provision taking effect within 180 days.
How This Relates to Executive Order 14292
This policy is the deliverable EO 14292 called for: CASRAI’s earlier coverage of Executive Order 14292 tracked the order’s three OSTP deadlines and reported that, as of that writing, none could be independently confirmed as met. The July 2026 USG Policy for Stopping High-Risk Life Sciences Research is that confirmation for the DURC/PEPP-replacement deliverable specifically — institutions should treat this policy, not the order’s original text alone, as the current operative framework for DGOF and IROC obligations going forward.
Mixed Reaction From the Research Community
Coverage since the policy’s release has reported a mixed response from the scientific and biosafety community. Some researchers and professional societies have raised concerns that the DGOF outcome-based definition is broad enough to potentially reach carefully regulated, lower-risk research alongside its intended targets, while proponents of the policy frame the shift to a risk-based test as closing gaps in the prior list-based approach. CASRAI has not independently verified specific attributed statements from that reporting and is not citing any here; institutions should treat this as an active, unsettled discussion rather than a resolved question, and watch for agency implementation guidance for how DGOF is actually applied in practice.
Frequently Asked Questions
Does the new policy ban all gain-of-function research?
No. It prohibits federal funding for research meeting the specific DGOF definition — an outcome-based test tied to significant negative societal consequences — not the broader category of routine gain-of-function techniques used throughout ordinary laboratory research.
What replaced the 2024 DURC/PEPP policy?
The USG Policy for Stopping High-Risk Life Sciences Research (framework dated July 20, 2026, released July 28, 2026) replaces the 2024 USG Policy for Oversight of DURC and Pathogens with Enhanced Pandemic Potential, moving from a largely list-based model to a risk-based DGOF/IROC framework.
When is agency-specific implementation guidance due?
Agencies have 120 days from the policy’s release to issue implementation guidance and publish their own lists of entities of concern under the international-research restrictions — roughly mid-November 2026.
Does the policy only apply to federally funded research?
No. While the funding restrictions and certification duties attach to federal awards, institutions also have a new duty to identify and report non-federally-funded potential-DGOF research annually to their primary federal life sciences funding agency.
What happens if ongoing research may meet the DGOF definition?
The policy requires that the research stop immediately, with notice to the funding agency within 24 hours, pending evaluation.
