New federal policy affecting life sciences research goes into effect Jan. 1, 2027

In late July, the federal government released a new U.S. Government Policy for Stopping High-Risk Life Sciences Research pursuant to Executive Order 14292 (Improving the Safety and Security of Biological Research). This policy significantly broadens the scope of life sciences research that must be assessed for potential impact to national security and public health, using an expansive definition of life sciences research. It also creates new requirements and restrictions around international life sciences research. The policy will take effect in January 2027.

While federal funding agencies are required to issue implementation guidance in November, campus leadership is actively preparing for implementation and assessing the policy’s impact on UW–Madison’s research enterprise. The policy replaces prior federal policies related to Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). Until the policy takes effect, research will continue to be reviewed based on the 2024 U.S. Government Policy for Oversight of DURC and PEPP as well as Executive Order 14292.

The new policy will require PI and institutional assessment of all proposed and ongoing life sciences research. Among other requirements:

• All PIs conducting life sciences research will be required to assess and complete an attestation before submitting a proposal or progress report regarding whether the research is Dangerous Gain of Function (DGOF) or Potential DGOF research, as defined under the policy. The University will also be required to review and confirm the accuracy of the PI’s assessment before submission to any federal funding agency.
• PIs conducting life sciences research will be required to provide the names and institutional affiliations of key personnel who will participate in the proposed research, including any proposed foreign collaborators, and describe any research activities that will take place outside the United States. The University will evaluate whether the proposed research involves individuals, institutions, or locations that may fall within the policy’s International Research of Concern (IROC) criteria and confirm the accuracy of the PI’s disclosures before submission.
• PIs will also be required to report changes to research aims, key personnel, and research institutions during the course of the research, as required by the applicable funding agency.

Additional guidance, training materials, and campus-specific procedures will be developed and shared as implementation details become available. We recognize that this new policy will place additional burdens on individual PIs as well as administrative units.

Resources:

• The policy can be found here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-101.html
• A summary from the Council on Governmental Relations (COGR) provides additional information on key definitions, policy changes, and requirements: https://www.cogr.edu/blog/summary-us-government-policy-stopping-high-risk-life-sciences-research>
• Additional UW–Madison information regarding compliance with Executive Order 14292 and the current DURC/PEPP oversight framework can be found on the UW–Madison DURC website: https://ehs.wisc.edu/labs-research/biological-safety/dual-use-research-of-concern-durc/

Questions?

Questions regarding the policy or its implementation may be directed to:

Christina Pier, MS, RBP (ABSA)
Select Agent Responsible Official (RO)
Institutional Contact for Dual Use Research (ICDUR)
Office of Biological Safety
Email: pier@wisc.edu

Questions about IROC, including applicable disclosure requirements, may be directed to:

Stephanie LeRoy
Interim Director of Research Security and Export Controls
Office of the Vice Chancellor for Research
Email: stephanie.leroy@wisc.edu