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“Stopping Policy”: How the University of Utah will implement the new federal policy on high-risk research

What U of U principal investigators need to know about dangerous gain-of-function (DGOF) and international research of concern (IROC).

Required Training   What is Prohibited   Process for PIs   Next Steps

In July 2026, the federal government released the U.S. Government Policy for Stopping High-Risk Life Sciences Research, commonly called the “Stopping Policy.” The policy prohibits or restricts federal funding for high-risk research, including dangerous gain-of-function (DGOF) research and risky international research of concern (IROC). It replaces all former federal policies on dual use research of concern (DURC) and pandemic pathogens.

The most significant change for our research community is scope: all life sciences research must now be screened for DGOF and IROC before a proposal is submitted, not just research involving a defined list of agents.

Key Deadline

Institutions must be in compliance by
January 16, 2027.

Agency-specific implementation guidance is expected from federal funding agencies in mid-November 2026.

Date

Milestone

July 2026

Policy released

Mid-November 2026

Agency-specific implementation policies due

January 16, 2027

Institutional compliance required

Required Training

Every PI conducting life sciences research will be required to complete the U of U “Stopping Policy” annual training and a pre-proposal PI survey. These will be available prior to the mid-January compliance deadline.

 

What is Prohibited

The following are prohibited from federal funding:

Research with a biological agent that seeks, achieves, or has a substantial risk of achieving one or more of the following outcomes and that could result in significant negative societal consequences:

  1. Enhanced harmful consequences
  2. Disrupted beneficial immunological response or effectiveness of immunization
  3. Resistance to clinically or agriculturally useful prophylactic or therapeutic interventions, or ability to evade detection
  4. Increased stability, transmissibility, or ability to disseminate
  5. Altered host range or tropism
  6. Enhanced susceptibility of a human, animal, or plant host population
  7. Generating or reconstituting an eradicated or extinct biological agent

Significant negative societal consequence means a substantially negative outcome or effect to a critical area or system, (e.g., public health, agriculture, the economy, national security, or the environment), such as hospital admissions surges, asset or trade losses, and restriction of an agriculturally important commodity. Significant negative societal consequences can also be caused by an information hazard, such as methods or technical insight that could enable harmful activities, such as a method that makes a pathogen easier to disseminate.

Research involving entities of concern, including countries, institutions, and individuals, as defined by federal agencies through an annually published list.

What may be allowed, with significant oversight

Potential DGOF and other research of international concern (ORIR) may be eligible for funding after review. This includes research with a non-trivial likelihood of resulting in DGOF, and research conducted in a country with inadequate oversight to ensure public health, safety, and economic or national security.

What the process will look like for PIs

The proposed U of U workflow for all PIs conducting life sciences research:

Pre-award

  • PI completes the “Stopping Policy” training and survey
  • The Institutional Review Entity (IRE) or Research Security Office (RSO) reviews flagged proposals
  • IRE and PI complete a risk/benefit analysis for any identified potential DGOF

Submission

  • PI attests to either no DGOF/IROC or potential DGOF/IROC
  • The U of U confirms the PI’s attestation
  • For potential DGOF or ORIR, the risk/benefit analysis is submitted with the proposal

Just-in-time (JIT)

  • For potential DGOF or ORIR, the IRE and PI complete a risk mitigation plan
  • The plan is provided for review by the federal Independent Third-Party Review Body (ITPRB)

Consequences of Noncompliance

Failure to comply can result in immediate revocation of ongoing federal funding, up to a five-year period of institutional ineligibility for life sciences funding, and additional penalties under federal law and regulations.

Next Steps

  1. We are awaiting implementation guidances from the federal funding agencies to inform the details of policy compliance. According to the policy, these are expected mid-November.
  2. In the meantime, we have begun to build the “Stopping Policy” required annual training and the pre-proposal PI survey.
  3. The “Stopping Policy” working group is building the required internal review process.
  4. The workflow for PI and University attestations at the time of proposal submission will be informed by the guidances.
  5. The training and survey will be completed in time for the mid-January compliance deadline

Who is leading this work?

The U of U “Stopping Policy” Working Group includes the Biosafety Office, Research Security Office (RSO), Office of Sponsored Projects (OSP), Institutional Biosafety Committee (IBC), and Office of General Counsel (OGC).

Resources

 

Questions?

Contact the Biosafety Officer  

Last Updated: 11/5/26