NOTICE: DURC PROGRAM PAUSED
On May 5, 2025, the White House Executive Action on Biological Research directs federal agencies to end funding for “dangerous gain-of-function research” and develop a new oversight policy within 120 days. This type of research is defined in Section 8 of the order.
In response, the NIH has released an updated notice on May 7, 2025, rescinding their previous DURC-PEPP Policy implementation guidance. Other federal funding agencies have not yet published updated guidance.
USC will continue to monitor developments and update this webpage as new information becomes available.
What is EH&S doing to comply with the new order?
When PIs submit grants, they will be faced with a new question related to “”dangerous gain-of-function research” as defined by the new Executive Order. If they indicate that the proposed research falls under at least one of the experimental outcomes for “dangerous gain-of-function research”, they will be required to immediately contact USC Biosafety for a Risk Assessment. The PI and Biosafety will work together to identify the applicability of their research on “dangerous gain-of-function research”. If identified as “dangerous gain-of-function research”, the PI will be advised to not submit the grant in its current form without major revisions since NIH is not accepting any competitive applications for grants for this type of research as of May 7th, 2025. The PI will additionally be asked to submit a new BUA to capture the updated work objective of the proposed grant.
Note: The funding agency will not be approving any research deemed as “dangerous gain-of-function research.”
Questions related to oversight of your research?
Contact USC EH&S Biosafety team at biosafety@usc.edu.
Dual Use Research of Concern (DURC) is defined in the US Government policy statement as “life sciences research that…could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.”
All US institutions that accept federal funding from any agency are required to develop, implement, and monitor a DURC program to ensure researcher compliance with the federal policy. USC’s Institutional Review Entity (IRE) is the monitoring organization in charge of DURC activities.
DURC Manual
The DURC Manual establishes guidelines to preserve the benefits of life sciences involving DURC research while minimizing the risk that the output of such research could be used for harmful purposes.
Additionally, it outlines the rules for the individuals and committees at USC who are responsible for the implementation of the Institution’s requirements with respect to DURC.
FAQs
To whom does this DURC policy apply?
Principal investigators that conduct high consequence research that involves pathogens with pandemic potential (PPP) and meet at least one experimental outcome for either identified category of research.
What is Category 1 and Category 2 Research?
Category 1 research is research that could be misapplied to do harm with little to no modification of the pathogen. Category 2 research is research that could enhance the pandemic potential of the pathogen (PEPP) from an existing pathogen with pandemic potential (PPP), non-PPP, or eradicated/extinct PPP.
How would a PI know if they are using a (PPP) in their research?
A pathogen with pandemic potential (PPP) is defined in the policy as:
- A pathogen likely capable of producing wide and uncontrollable spread in a human population and would likely cause moderate to severe disease in humans.
- Has efficient means of transmission (i.e., via aerosol, respiratory droplets, direct contact).
- Lack of pre-existing immunity for human populations.
- Lack of available non-medical and medical countermeasures.
How is Category 1 research defined?
Category 1 research must meet the following criteria. 1). Research that is conducted with any pathogens or biological toxins noted in the sections below. 2). Research must meet the requirements of at least one of the experimental outcomes defined in the DURC policy.
- Biological select agents and toxins as listed in 42 CFR 73, 9 CFR 121, or 7 CFR 331.
- All Risk Group 4 agents listed in Appendix B of NIH Guidelines.
- A subset of Risk Group 3 agents listed in Appendix B of NIH Guidelines.
- Any biological agents affecting humans that have not yet been assigned a risk classification and recommended to be handled at BSL-3 or BSL-4.
See Select Agents & Toxins and Risk Group Pathogens lists.
How is Category 2 research defined?
Category 2 research must meet the following criteria. 1). Any pathogen that is modified in such a way that is reasonably anticipated to result in the development, use or, transfer of a pathogen of enhanced pandemic potential (PEPP). This includes the development of new PPPs from non-PPPs as well as the enhancement of existing PPPs. 2). Research must also meet requirements of at least one of the experimental outcomes as defined in the DURC policy.
What does “reasonably anticipated” mean?
Describes an assessment of an outcome that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood.
What are the PI’s responsibilities?
- Assess whether the proposed/ongoing research might fall under the scope of the DURC policy.
- Inform the Biosafety Office of this assessment when submitting a grant through the Cayuse system.
- Work with the IRE to develop a risk mitigation plan if research is funded.
- Report progress every six (6) months.
- Continually assess throughout the lifecycle of the research.
What are the steps in the DURC approval process?
The steps in the DURC approval process are summarized in the diagram below.
What are the steps involved in the IRE review process?
The IRE review process is summarized in the diagram below.
