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Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential
governmentDirectly relevant to AI safety discussions around dual-use research governance; offers a regulatory model for managing high-risk research that may inform analogous AI oversight frameworks, particularly around capability thresholds and institutional review processes.
Metadata
Importance: 62/100guidance documentprimary source
Summary
This May 2024 U.S. federal policy establishes a unified oversight framework for dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPPs), superseding earlier 2012/2014 DURC policies and the P3CO Framework. It defines two categories of regulated research, assigns responsibilities to principal investigators, institutions, and funding agencies, and creates risk assessment mechanisms for biological research that could threaten public health or national security. The policy took effect May 6, 2025.
Key Points
- •Supersedes 2012 Federal DURC Policy, 2014 Institutional DURC Policy, and P3CO Framework, consolidating them into a single unified oversight structure.
- •Defines Category 1 (DURC) and Category 2 (PEPP) research with specific biological agents, experimental outcomes, and risk assessment requirements for each.
- •Establishes layered responsibilities: principal investigators identify risks, institutions conduct review, and federal funding agencies provide oversight and final determinations.
- •Includes provisions for waivers during urgent research/response situations and addresses non-federally funded and international research contexts.
- •Issued by OSTP under the 2022 National Biodefense Strategy and NSM-15, reflecting high-level political commitment to biosecurity governance reform.
Cited by 1 page
| Page | Type | Quality |
|---|---|---|
| Bioweapons Risk | Risk | 91.0 |
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# United States Government Policy for Oversight of Dual Use Research of Concern
# and Pathogens with Enhanced Pandemic Potential
May 2024
**United States Government Policy for Oversight of Dual Use Research of Concern** **and Pathogens with Enhanced Pandemic Potential**
**Issue date: May 6, 2024** Effective date: May 6, 2025
**Contents**
Section 1. Introduction ... 2
1.1 Purpose ... 2
1.2 Applicability of Policy ... 3
1.3 Relationship to Statutes, Regulations, and Other Policies ... 4
Section 2. Background, Policy Statement, and Guiding Principles ... 5
2.1 Background ... 5
2.2 Policy Statement ... 6
2.3 Guiding Principles ... 6
Section 3. Definitions ... 8
Section 4. Category 1 and Category 2 Research that is Subject to this Policy ... 10
4.1 Category 1 Research ... 10
4.1.1 Biological Agents and Toxins within Scope of Category 1 Research ... 10
4.1.2 Category 1 Research Experimental Outcomes ... 11
4.1.3 Category 1 Risk Assessment ... 12
4.2 Category 2 Research ... 12
4.2.1 Biological Agents within Scope of Category 2 Research ... 13
4.2.2 Category 2 Research Experimental Outcomes or Actions ... 13
4.2.3 Category 2 Risk Assessment ... 13
Section 5. Oversight Framework for Category 1 and Category 2 Research ... 14
5.1 Responsibilities of Principal Investigators ... 15
5.2 Responsibilities of Research Institut ions ... 17
5.3 Responsibilities of Federal Funding Agencies ... 21
5.4 Non-Federally Funded Research ... 25
5.5 Waiver for Urgent Research and Response ... 25
5.6 Failure to Follow the Research Oversight Framework ... 26
5.7 Reporting by Federal Departments and Agencies ... 26
Section 6. Research Outside of Policy Scope ... 27
6.1 Types of Research Typically Not Within Scope of Category 2 Research ... 27
6.2 Voluntary Guidance for Other Types of Research that May Pose Biosafety or Biosecurity Risks .. 28
6.2.1 Research with Other Human and Zoonotic Biological Agents and Toxins ... 28
6.2.2 Research involving In Silico Models and Computational Approaches ... 28
6.3 Entities that Do Not Receive Federal Funding ... 28
Section 7. Additional Resources ... 29
Section 8. Policy Review and Revision ... 29
**Section 1. Introduction**
**1.1 Purpose** The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Policy”) is a unified federal oversight framework for conducting and managing certain type s of federally funded life sciences research on biological agents and toxins. This Policy addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, ec onomic security, or national security.
1 It supersedes the 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern ( Federal DURC Policy), 2 the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Institutional DURC Polic
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