Dual Use Research of Concern (DURC)

Introduction

Dual use research of concern (DURC) is life sciences research that can be anticipated to provide knowledge, products or technologies that could be directly misapplied to pose a significant threat to public health, agriculture, the environment or national security.

  • In 2012, the United States government initially released a policy for institutional oversight of life sciences dual use research of concern. 
  • In 2024, the scope of policy was expanded to encompass a wider breadth of research as delineated by two categories along with an an amended oversight framework. 
  • The Institutional Review Entity (IRE) is the university committee which provides oversight for DURC.

Standards & Regulations

Applicability

This Policy applies to federal departments and agencies that fund or sponsor intramural or extramural research at research institutions in the United States and internationally with biological agents or toxins where the research is within Category 1 or Category 2 under this Policy, as described in Section 4 (“federal funding agencies”). This includes research funded or sponsored by grants, contracts, cooperative agreements, and other agreements and transactions issued on or after the effective date of this Policy. This Policy covers the research proposal stage and the full life cycle of the research. Non-federally funded research at institutions that receive federal funding is addressed in Section 5.4 of this Policy. Research that is outside of the scope of this Policy but may benefit from voluntary risk assessment and mitigation is addressed in Section 6.

This Policy provides an oversight framework for research with biological agents or toxins that is within Category 1 or Category 2. It includes measures for federal funding agencies to establish and implement this research oversight framework, including in terms and conditions of funding documents for research institutions and principal investigators. Federal funding agencies should implement this Policy under statutory and regulatory authorities applicable to them, and should aim to develop and promote consistent processes across the agencies to the maximum extent appropriate.

Category 1 Research

Category 1 Research meets three criteria:

  1. It involves one or more of the biological agents and toxins (specified below);
  2. It is reasonably anticipated to result, or does result, in one of the experimental outcomes (specified in Section 4.1.2); and
  3. Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC as (specified in Section 4.1.3)

Biological Agents and Toxins within Scope of Category 1 Research:

  • All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - Classification of Human Etiologic Agents on the Basis of Hazard.
  • A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines - Classification of Human Etiologic Agents on the Basis of Hazard.
  • For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). In such cases, agents affecting humans that are recommended to be handled at Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) per the BMBL guidance are subject to this Policy.
  • Biological agents added during future updates to the Implementation Guidance.

Category 1 Research Experimental Outcomes: 

  1. Increase transmissibility of a pathogen within or between host species;
  2. Increase the virulence of a pathogen or convey virulence to a non-pathogen;
  3. Increase the toxicity of a known toxin or produce a novel toxin;
  4. Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin; 
  5. Alter the host range or tropism of a pathogen or toxin;
  6. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
  7. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions;
  8. Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against the pathogen or toxin; or
  9. Enhance the susceptibility of a host population to a pathogen or toxin.

Category 2 Research

Category 2 research meets three criteria:

  1. It involves, or is reasonably anticipated to result in, a pathogen with pandemic potential (PPP) as specified in Section 4.2.1;
  2. It is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions (specified in Section 4.2.2); and
  3. Based on current understanding, the research institution and/or federal funding agency assesses that the research is reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security (specified in Section 4.2.3)

Category 2 Research Experimental Outcomes: 

  1. Enhance transmissibility of the pathogen in humans;
  2. Enhance the virulence of the pathogen in humans;
  3. Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection; or
  4. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP. Illustrative examples of Category 2 Research Experiments that should require PI, IRE, and federal funding agency review and approval are presented in the Implementation Guidance.

Oversight Framework for Category 1 and Category 2 Research

  1. The PI makes an initial assessment of whether their proposed or ongoing research may be within the scope of Section 4 based upon the biological agent or toxin and the experimental outcome or actions (as specified in Sections 4.1.1 and 4.1.2 for Category 1 research, and Sections 4.2.1 and 4.2.2 for Category 2 research, respectively). The research institution is responsible for ensuring that PIs are aware of and executing this responsibility appropriately.
  2. The PI submits the research proposal to the federal funding agency including notification that the research may be within scope of Category 1 or Category 2 based on the biological agent or toxin and the experiment.
  3. When the federal funding agency has completed merit review of the proposed research and if it is considering funding the proposed research, the federal funding agency notifies the research institution.
  4. The research institution, through an IRE, reviews the PI’s initial assessment and confirms whether proposed or ongoing research is within the scope of Category 1 or Category 2 research. If so, the IRE determines whether the research is Category 1 or Category 2, including based on a risk assessment under Section 4.1.3 (Category 1) or Section 4.2.3 (Category 2). The research institution notifies the federal funding agency of the results of its Category 1 or Category 2 research determination, and the federal funding agency evaluates and verifies the research institution’s assessment. Examples of risk assessment methods are described in the Implementation Guidance.
  5. If the research is assessed to be within scope of Category 1 or Category 2, the research institution, through an IRE, conducts risk-benefit assessments and develops a draft risk mitigation plan for the conduct and communication of research. The PI or research institution submits the risk-benefit assessment and a draft risk mitigation plan to the federal funding agency. Examples of risk mitigation approaches are described in the Implementation Guidance.
  6. The federal funding agency reviews the risk-benefit assessment and draft risk mitigation plan as follows: (a) For specific experiments within the research proposal determined to be within scope of Category 1, the federal funding agency evaluates the research institution’s risk benefit assessments and determines whether the potential benefits justify the potential risks prior to the funding decision. These specific experiments will not proceed until the federal funding agency approves the risk mitigation plan. (b) For specific experiments within the research proposal determined to be within scope of Category 2, the federal funding agency refers the proposed research for department-level review.24 Upon receipt of the Category 2 research proposal, the department convenes a multidisciplinary review entity to evaluate the research institution’s risk-benefit assessments and risk mitigation plan prior to the federal funding agency making a funding decision on the research proposal. The multidisciplinary review entity will make recommendations to the federal funding agency regarding the risk-benefit assessments, risk mitigation plan, and research proposal funding. The specific experiments within the research proposal determined to be within scope of Category 2 will not proceed until the federal funding agency determines that the potential benefits justify the potential risks and approves the risk mitigation plan.
  7. If research is identified as potentially within the scope of Category 1 or Category 2 research during the course of experimentation, the PI halts further work, notifies the federal funding agency and research institution, and contacts their IRE to conduct the required assessments consistent with the procedures in this Policy for assessing Category 1 or Category 2 research.

It is the responsibility of investigators and institutions to identify research that may fall within scope of Category 1 or Category 2 research. Federal funding agencies have the discretion to request additional information or review of individual research proposals or projects to determine whether they may fall within scope of Category 1 or Category 2 research.

IRE Members

The IRE committee is composed of the Institutional Biosafety Committee technical experts, the Director of Research Compliance and the Institutional Contact for Dual Use Research (ICDUR) who is also the EH&S Biosafety Officer.

IRE Policy & Procedures