High-Risk Life Sciences Research (IRE)
Researchers and institutions are subject to oversight of life sciences research. Certain categories of biological research deemed to present unacceptable risks are prohibited. Prohibited categories include International Research of Concern, Other Risky International Research, and Dangerous Gain-of-Function Research.
High-Risk Life Sciences Research Menu
High-Risk Life Sciences Research News and Announcements
In July, the federal government released the U.S. Government Policy for Stopping High-Risk Life Sciences Research. The purpose of this Policy is to identify and prohibit certain categories of biological research that are deemed to present unacceptable risks.
Federal funding agencies are expected to issue implementation guidance by November 17, 2026. Following the release of that guidance, the Office for Research Protections will develop an implementation plan and provide additional information regarding researcher responsibilities and institutional requirements. In the interim, If you believe your research will be impacted by this Policy or have questions, please let us know by emailing one of the programs listed below:
- Research Safety and Compliance: orp-biosafety@psu.edu
- Research Security Program: research-security-orp@psu.edu
Policy Overview
The purpose of the U.S. Government Policy for Stopping High-Risk Life Sciences Research is to identify and prohibit certain categories of high-risk biological research at institutions receiving federal life sciences research funding. These categories include:
- International Research of Concern (IROC): Life sciences research involving entities of concern, including research conducted in a country of concern or conducted outside the US by an institution or individual of concern.
- Other Risky International Research: Life sciences research that could reasonably pose a threat to public health, public safety, economic security, or national security conducted in a country with inadequate oversight to ensure compliance with US standards and policies.
- Dangerous Gain-of-Function (DGOF) Research : Research that enhances one or more properties of a biological agent in ways that make it more dangerous. This designation applies to research that seeks, achieves, or poses a substantial risk of achieving one or more of seven specified experimental outcomes and could result in significant negative societal consequences (see Section 6.e.i-vii of the Policy referenced above for a list of the seven experimental outcomes).
- Potential DGOF Research: Research with a biological agent that could potentially result in one or more of those seven experimental outcomes and could result in significant negative societal consequences. Potential DGOF is not categorically prohibited, but federal funding may proceed only through the institutional review and federal review processes established by the Policy.
Key Impacts
- The risk-based approach applies to a broad spectrum of research activities.
- There are new requirements for international research of concern (IROC).
- Institutions must review ongoing and proposed research (both federally and non-federally funded) and report on dangerous gain-of-function (DGOF) research/potential DGOF research.
- PIs and institutions have primary review responsibility.
- PIs must personally attest their research determinations and institutions attest that the PI’s attestation is correct
Institutions must be in full compliance with the Policy by January 16, 2026. Penn State Policy RP10 and the CATS Safety protocol submission platform will both be updated to align with the new Policy changes.
Implementation
Federal funding agencies are expected to issue implementation guidance by November 17, 2026. We anticipate lists of entities of concern being made public with the implementation guidance. Following the release of that guidance, the Office for Research Protections will develop an implementation plan and provide additional information regarding researcher responsibilities and institutional requirements.
Institutions must be in full compliance with the Policy by January 16, 2027. Given the narrow implementation and compliance timeline, we encourage researchers to be on the lookout for future communications and start assessing whether any current or planned research activities may be impacted by this Policy.
Office for Research Protections
Address
200 Innovation Blvd.
Suite 110
University Park, PA 16802
The Office for Research Protections (ORP) ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.