January 10, 2025
None
NATIONAL INSTITUTES OF HEALTH (NIH)
The purpose of this Notice is to provide researchers and research institutions funded by National Institutes of Health (NIH) grants and cooperative agreements with information pertaining to NIHs implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (herein referred to as the DURC/PEPP Policy).
NIH intends to implement the DURC/PEPP Policy effective May 6, 2025. NIH will provide additional details and requirements, including applicable grant and cooperative agreement activity codes, specific implementation timelines, and information regarding implementation for other NIH funding mechanisms, (e.g., contracts, Other Transactions), in future Guide Notices.
Applicability
The DURC/PEPP Policy requirements apply to all NIH-funded research, including grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions).
For competing grant and cooperative agreement applications, NIH will request applicable DURC/PEPP materials to be provided as part of Just-in-Time (JIT) materials submitted on or after May 6, 2025. DURC/PEPP materials must be submitted by the Authorized Organizational Representative (AOR).
For active grants and cooperative agreements, NIH will request applicable DURC/PEPP materials to be provided as part of any non-competing applications, including Research Performance Progress Reports (RPPRs), due on or after May 6, 2025. Non-competing applications that include DURC/PEPP materials must be submitted by an AOR.
Background
Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. As part of ongoing updates and assessments of existing policies, the United States Government (USG) released the DURC/PEPP Policy which merges, revises, and supersedes the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (2012 Federal DURC Policy), the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014 Institutional DURC Policy), the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (2017 OSTP P3CO Policy Guidance), and the Department of Health and Human Services (HHS) Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (2017 HHS P3CO Framework).
To better streamline implementation, the new DURC/PEPP Policy defines and outlines oversight requirements for two categories of research at USG-funded institutions — Category 1 research involving dual use research of concern (DURC), and Category 2 research involving pathogens with enhanced pandemic potential (PEPP), as defined therein.
The DURC/PEPP Policy expands oversight of DURC to a wider scope of agents including all Select Agents and Toxins, all Risk Group 4 and most Risk Group 3 agents listed in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), and biological agents added during future updates to the DURC/PEPP Policy Implementation Guidance. There will be new oversight roles for researchers, applicants, recipients, NIH, and HHS. The DURC/PEPP Policy addresses the identification and mitigation of biosafety, biosecurity, and information risks associated with manipulation of certain pathogens that could cause significant harm to society, be it accidental or intentional. Updates reflect the evolving nature of scientific and technological risks.
Per the DURC/PEPP Policy, NIH will not fund Category 1 or Category 2 research in countries identified by the USG as posing risks in which the USG should not fund Category 1 and Category 2 research (hereafter, Countries of Concern). The current Countries of Concern, listed in the DURC/PEPP Policy Implementation Guidance, are the Democratic Peoples Republic of Korea (DPRK), the Islamic Republic of Iran, the Russian Federation, the Peoples Republic of China (along with the Special Administrative Regions of Hong Kong and Macau, for the purposes of this policy), Cuba, Syria, and Venezuela. This list is subject to change as determined by the USG.
General Expectations for Applicant and Recipient Institutions and Researchers
It is the responsibility of all NIH applicants and recipients, through their Principal Investigators (PD/PIs) and other Senior/Key Personnel (researchers) named in the application, to assess whether or not their research, for which NIH funding is received or sought, falls under the scope of Category 1 and/or Category 2 research. Applicants and recipients seeking to conduct research within the scope of this policy will be required to have an Institutional Review Entity (IRE) and an Institutional Contact for Dual Use Research (ICDUR). Composition and responsibilities of the IRE and ICDUR are outlined in the DURC/PEPP Policy. Researchers must work with their IRE to develop a risk-benefit assessment and risk mitigation plan, as needed, that must be approved by NIH before this work can begin or continue. Once awarded, recipients, through their PD/PIs, must carry out and oversee research according to the approved plan. Recipients and applicants are expected to develop necessary infrastructure and personnel to comply with the DURC/PEPP Policy. NIH strongly recommends institutions begin training relevant staff on the DURC/PEPP Policy.
Overview of Key Requirements
Recipients, through their researchers, must assess their research at the proposal stage and continuously throughout the research life cycle for whether the research falls under the scope of Category 1 and/or Category 2 research as described in the DURC/PEPP Policy and Implementation Guidance.
For any project that the researcher considers potentially to be Category 1 or Category 2 research, once the applicant receives notification from NIH to provide materials, if applicable, through an official JIT request from the Institute/Center, the researcher must work with their IRE to determine whether it meets the definition of Category 1, Category 2, or neither.
For any project assessed by the IRE, applicants and recipients must submit to NIH, via their AOR, the applicable DURC/PEPP materials as outlined below.
NIH will require institutional assessments of awards that are active at the time the policy goes into effect. For grants and cooperative agreements, NIH will review such assessments at the time of the next RPPR or other non-competing application (e.g., Type 7 Change-of-Institution application).
After receiving the materials, NIH will review the IRE determination, risk-benefit assessment, and risk mitigation plan. NIH will refer Category 2 research to HHS for Department-level review. NIH may request additional materials pertaining to the research from the applicants and recipients. The funding Institute or Center will make the final funding determination and add relevant terms and conditions to the Notice of Award.
Recipients, through their PD/PIs, must carry out and oversee Category 1 or Category 2 research in accordance with the approved risk mitigation plan and award terms and conditions. At a minimum, Category 1 research will require submission of annual reports and Category 2 research will require semi-annual reports. Recipients must report all compliance issues to NIH.
NIH will provide further instructions of material content, submission requirements, and implementation timelines in a future Guide Notice.
Applicable DURC/PEPP Materials
For projects reviewed by the IRE, NIH will require the following documentation, as applicable:
Details regarding the specific content and format of these materials will be published in a subsequent Guide Notice.
Other Responsibilities
On an annual basis, NIH-funded recipients must provide a formal assurance to NIH that the research institution is operating consistent with the policy.
Applicants and recipients are strongly encouraged to implement oversight of non-federally funded Category 1 or Category 2 research conducted in their institutions in accordance with the DURC/PEPP Policy but are not required to attest such oversight activity to NIH.
This DURC/PEPP Policy does not supersede other federal biosafety or biosecurity regulations, such as the Select Agent Regulations. NIH-funded Category 1 or Category 2 research must be conducted in compliance with all applicable federal, state, and local laws, regulations, policies, and guidelines.
Other Information
NIH strongly encourages researchers and research institutions to become familiar with the DURC/PEPP Policy, associated Implementation Guidance, and the Administration for Preparedness and Response (ASPR) S3 website and FAQs.
NIH will continue to provide updates as additional implementation details are finalized.
For general questions related to this policy, please contact:
National Institutes of Health
Office of Science Policy
[email protected]
For grants administration and system questions related to this policy, please contact:
NIH Office of Policy for Extramural Research Administration (OPERA)
Systems Policy Branch
[email protected]