Dual Use Research of Concern
Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies 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.The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
Watchthe video“Dual Use Research: A Dialogue”
U.S. Government DURC Policies
External Resources
Research Involving Enhanced Potential Pandemic Pathogens (ePPP)
The U.S. Government and the Department of Health and Human Services define enhanced potential pandemic pathogen(ePPP) research as research that may be reasonably anticipated to create, transfer or use potential pandemic pathogens resulting from the enhancement of a pathogen’s transmissibility and/or virulence in humans.
ePPP research can help us prepare for the next pandemic, for example by informing public health and preparedness efforts including surveillance and the development of vaccines and medical countermeasures. However, such research requires strict oversight and may only be conducted with appropriate biosafety and biosecurity measures.
The HHSFramework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework)was established in 2017 to guide HHS funding decisions on proposed ePPP research and aims to preserve the benefits of life sciences research involving ePPPs while minimizing potential biosafety and biosecurity risks. The HHS P3CO Framework is responsive to and in accordance with theRecommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversightissued by the White House Office of Science and Technology Policy following a three-year, public deliberative process.
Department of Health and Human Services P3CO Framework
U.S. Government Policy on Enhanced PPP Research
Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Development
NSABB Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research
FAQs on the U.S. government Gain-of-function Deliberative Process and Research Funding Pause
Symposia Summaries and Commissioned Reports
Risk and Benefit Analysis of Gain of Function Research – Final Report(Gryphon Scientific)
Gain-of-Function Research: Ethical Analysis(Professor Michael J. Selgelid)
Additional Material
NIH Director’s Statement on Funding Pause on Certain Types of Gain-of-Function Research
NIH Director’s Statement on Lifting of NIH Funding Pause on Gain-of-Function Research
Supplemental Information on the Risk and Benefit Analysis of Gain-of-Function Research
Gain-of-Function Deliberative Process Written Public Comments (Nov 10, 2014 – June 8, 2016)
External Resources
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
TheNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules(NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
- NIH Guidelines – April 2024 (PDF) (Printer friendly for duplex printing)
- NIH Guidelines – April 2024 (HTML)
- Federal Register Notice – April 2024
- Biosafety Considerations for Contained Research Involving Gene Drive Modified Organisms
Incident Reporting
The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses” be reported to OSP within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).
- Incident Reporting FAQs – December 2023
- Incident Reporting Template – April 2019
*Incident reports may be released to the public in full. Please note that incident reports should not include personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in the report. If it is necessary to include such information, please clearly mark it as such so that it can be considered for redaction in accordance with Freedom of Information Act exemptions.*
IBC RMS and Registration Information
The Institutional Biosafety Committee Registration Management System (IBC-RMS) supports the online submission of IBC registrations and annual registration updates. IBC-RMS users can access the system to keep track of their institution’s registration status, view IBCs currently registered with OSP, and access important compliance guidance relating to the NIH Guidelines. The IBC-RMS also allows users to send policy questions directly to OSP through the Web interface.
- Institutional Biosafety Committee Registration Management System (IBC-RMS)
IBC Self-Assessment Tool
- IBC Self-Assessment Tool – April 2024
Investigator Brochure
- Investigator Responsibilities under theNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules– October 2021
Links to Other Biosafety Resources
Additional Resources
- CDC Biosafety Resources and Tools
- American Biological Safety Association (ABSA)
- AIHA Home Page
- American Society for Microbiology
- The American Society of Gene and Cell Therapy
- Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Website
- The Centers for Disease Control and Prevention (CDC) Website
- The US Department of Health and Human Services (HHS)
- The Office for Human Research Protections (OHRP)
- The Federal Register Website
- The Office of Laboratory Animal Welfare
- The Animal and Plant Health Inspection Service (APHIS) Website
- Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- Risk Group Classification for Infectious Agents (ABSA)
- Select Agent Program
- Association for the Accreditation of Human Research Protection Programs
- Biosafety Discussion List