High-Risk Life Sciences Research
Overview
The U.S. Government has issued a new policy entitled "United States Government Policy for Stopping High-Risk Life Sciences Research." Approved on July 20, 2026 and publicly released on July 28, 2026, the policy establishes new requirements for federally funded life sciences research and prohibits certain categories of research considered to pose unacceptable risks to public health, public safety, and national security.
The policy replaces the previous federal oversight framework for Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) and adopts a broader risk-based approach to evaluating biological research.
Key Changes
- Prohibition on Dangerous Gain-of-Function Research
The most significant change is an explicit prohibition on federal funding for Dangerous Gain-of-Function (DGOF) Research
Under the policy, DGOF research involves biological agents where the research seeks, achieves, or presents a substantial risk of producing outcomes that could make an organism more dangerous and result in significant societal harm. Examples may include increasing transmissibility, pathogenicity, resistance to medical countermeasures, or expanding host range.
Research determined to meet the DGOF definition is not eligible for federal support.
- Enhanced Review of Potentially High-Risk Research
The policy establishes additional review requirements for research that could potentially create dangerous biological outcomes.
Researchers, institutions, and funding agencies will be expected to evaluate proposed work for characteristics defined in the policy and document their assessments. Certain projects may undergo independent review before funding decisions are made.
This represents a shift from reliance on pathogen lists toward a broader evaluation of research outcomes and societal consequences.
- Restrictions on International Research
The policy creates a category known as International Research of Concern (IROC).
Federal funding may not support certain life sciences research conducted:
- In designated foreign countries of concern.
- By foreign institutions or individuals of concern.
- In locations lacking adequate oversight, biosafety, or biosecurity controls.
Institutions engaging in international collaborations may be required to demonstrate that research activities meet U.S. oversight expectations and do not create unacceptable risks.
University Implementation Status
The University is currently reviewing the newly released U.S. Government Policy for Stopping High-Risk Life Sciences Research and evaluating what updates may be needed to institutional policies, procedures, and oversight processes to ensure compliance with federal requirements. The federal government has indicated that agencies will issue additional implementation guidance to research institutions within 120 days of the policy's issuance.
At this time, investigators should continue to follow existing University research compliance, biosafety, and Institutional Biosafety Committee (IBC) requirements. The University is actively monitoring federal announcements and awaiting agency-specific implementation guidance before making final determinations regarding policy changes.
As additional information becomes available, the University will provide updates to the research community and revise relevant policies and procedures as necessary.
Training
The U.S. Government Policy for Stopping High-Risk Life Sciences Research includes new training expectations for individuals involved in covered life sciences research activities as part of the broader framework for strengthening oversight, accountability, biosafety, and biosecurity.
EHS is currently developing a new training program to address the policy's training requirements. We are awaiting additional federal implementation guidance to ensure the training aligns with agency expectations and regulatory requirements. Additional information regarding training content, applicability, and completion deadlines will be communicated to the research community as it becomes available.
Questions?
For assistance evaluating research under the new federal policy, please contact the Biosafety Officer. Contact information and areas of expertise can be found on the Contact Us page.
Resources
Coming soon