Dual Use Research of Concern (DURC)

Scope

This policy applies to all Indiana University faculty, staff,students, and affiliate investigators involved or potentially involved in Dual Use Research of Concern (DURC) or research involving Pathogens with Enhanced Pandemic Potential (PEPP) (Definitions).

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Policy Statement

It is the policy of Indiana University that all research projects involving biological agents or toxins specified in the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential are subject to review and approval by the institution prior to project initiation. Dual Use Research of Concern (DURC) means life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. A Pathogen with Enhanced Pandemic Potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupts the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security.

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Reason for Policy

This policy complies with the United States Government Policy for Oversight of DURC and PEPP, which applies to institutions receiving federal funding to conduct certain types of life science research. The policies are intended to preserve the benefits of life sciences research while ensuring safe research practices and mitigating risks.

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Procedures

A. Obligation of Researchers to Identify Research that May Constitute DURC or PEPP Research

The Principal Investigator (“PI”) must be knowledgeable about and comply with all applicable institutional and US Government policies, requirements, and regulations for oversight of biological agent and toxin research. The PI must assess their research at the proposal stage, using the IU Self-Assessment Form throughout the research lifecycle to identify whether their research is reasonably anticipated to be within the scope of Category 1 (DURC) or within the scope of Category 2 (PEPP) (see Definitions).

If, during the Self-Assessment, the PI determines that their proposed research falls within the scope of either Category 1 or Category 2, the PI must notify the Institutional Review Entity (IRE) (see Definitions) and the federal funding agency and prepare to submit a risk-assessment and draft risk mitigation plan. 

• If research is being proposed as part of a new funding proposal, submit the risk-benefit assessments and draft risk mitigation plan to the federal funding agency for review and approval following scientific merit review.

•  If the research is being funded under an existing funding mechanism but has not yet been reviewed by the federal funding agency, submit the risk-benefit assessments and draft risk mitigation plan to the federal funding agency for approval before conducting such work.

• If research is first identified as potentially within scope of Category 1 or Category 2 during the course of experimentation, halt further research and work with the IRE to develop the risk-benefit assessments and risk mitigation plan for submission to the federal funding agency for further review and approval to continue work.

If the proposed research is approved by the IRE and funded by the federal funding agency, the PI must then submit their research to the Institutional Biosafety Committee (IBC) for review. The IBC will review the planned research to ensure adherence to the mitigation plan developed by the PI and the IRE and that all laboratory personnel are educated and trained on DURC./PEPP research.

B. Institutional Review

The IU Institutional Review Entity (IRE) shall conduct an institutional assessment to confirm the information on the PI's self-assessment form. It the proposed research is confirmed to fall within the scope of Category 1 or Category 2 of the policy, and the funding agency is considering funding, the IRE will notify the federal funding agency of its assessmnent.

After the federal funding agency completes its evaluation and assessment and notifies the IRE and PI of the results, the IRE will work with the PI to develop and submit a risk-benefit assessment and risk mitigation plan. Neither Category 1 nor Category 2 research may begin until the federal funding agency has approved the risk mitigation plan. All risk mitigation plans for Category 1 research must be reviewed by the IRE at least annually. Category 2 research must be reviewed by the IRE at least semiannually. Additional ad hoc members may be added to the IRE as needed based on the research under review.

While the federal funding agency conducts their review, the PI may submit a protocol to the Institutional Biosafety Committee (IBC). Concurrent with the funding agency review, the IBC shall review the PI-submitted protocol and forward it to the IRE. The IC may provide input and make any recommendations to the IRE.

The IRE will ensure that education and training on DURC and PEPP research is completed by individuals conducting life science research with a Non-attenuated Agent or Toxin of Concern.

The IRE-appointed Institutional Contact for Dual Use Research (ICDUR) will serve as an internal resource regarding oversight of Category 1 or Category 2 research. If questions arise regarding implementation of this policy, or when guidance is needed about identifying Category 1 or Category 2 research or developing risk mitigation plans, the ICDUR serves as the liaison (as necessary) between the research institution and federal funding agencies.

C. Reporting and Plan

Within 30 days of the initial review, the institution, through the Office for Research Compliance, will provide the outcome of the IRE review to the appropriate federal funding agency. This should include all information required by the policy for Institutional DURC and PEPP Oversight.

Within 90 days of the IRE review, the institution will provide the draft risk mitigation plan for final review and approval to the federal funding agency.

D. Records

The policy for Institutional DURC and PEPP Oversight requires that all records of IRE review and completed risk mitigation plans be kept for three years after the completion of the project, but no less than eight years after the review or completion of the mitigation plan. The Office for Research Compliance shall keep the IRE and associated records in accordance with this and any other recordkeeping requirements.

E. Noncompliance

Any noncompliance with this policy, the approved risk mitigation plan, or federal regulations will be reported to the appropriate federal funding agency by the ICDUR within 30 days. In addition, the institution may impose additional sanctions on the PI or lab based on the noncompliance issues found.

F. Appeals

Disputes regarding interpretation of this policy or decisions made by the IRE are referred to the Vice President for Research, who may: deny the appeal, or request that parts of a previous decision by the IRE be reconsidered by the committee. The IRE shall reconsider the determination after receiving input from the Vice President for Research and the IBC. After this reconsideration, the subsequent decision of the IRE shall be final.

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Definitions

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 misapplied to do harm with no, or only minor modification, to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Pathogen with Enhanced Pandemic Potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential.   

Pathogen with Pandemic Potential (PPP) is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.

Federal Funding Agency is a federal department, agency, institute, center, or office that funds or sponsors intramural or extramural research at research institutions in the United States or internationally, with biological agents or toxins where the research is within Category 1 or Category 2 under this policy. 

Institutional Review Entity (IRE) is the entity established by the research institution to execute the institutional oversight responsibilities described in this policy. The Committee will be comprised of:

• Indianapolis IBC Chair
• Indianapolis IBC Vice Chair
• Bloomington IBC Chair
• Biosafety Manager- Indianapolis, Environment Health and Safety
• Biosafety Manager-Bloomington, Environmental Health and Safety
• Research Safety Director, Environmental Health and Safety
• University Director IU University Environmental Health and Safety
• Chief Research Security Officer
• Director of Export Control
• Representative from a campus occupational health programs
• Associate Vice President, Office for Research Compliance
• Associate Vice President, Office for Research Administration
• University Director, Proposal and Award Services, Office for Research Administration

Ad hoc members may be utilized to ensure familiarity with the subject matter of the research.

Reasonably Anticipated describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.

Institutional Contact for Dual Use Research (ICDUR) is the official designated by the research institution to serve as an internal resource for application of this policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.

Category 1 Research is research that meets three criteria:

1. It involves one or more of the biological agents and toxins specified in Section 4.1.1 of the USG Policy
2. It is reasonably anticipated to result, or does result in one of the following experimental outcomes (Section 4.1.2 of the USG Policy)

• 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. Increases resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therpeutic 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;
  10. And, based on current understanding, the research can be reasonably anticipated to provide, or does provide, knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor modiciation to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security (Section 4.1.3 of the USG Policy)

Category 2 Research is research that meets three criteria: 

1. It involves, or is reasonably anticipated to result in, a PPP, or any pathogen that will be modified in such a way that it is reasonably anticipated to result in a PPP (Section 4.2.1 of the USG Policy)
2. It is reasonably anticipated to result, or does result, in one of the following experimental outcomes (Section 4.2.2 of the USG Policy)
   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.
3. And, the research can be 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.

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Sanctions

University faculty, staff, and students who are found to be in violation of this policy may be subject to restrictions on research and may also be subject to sanctions under other university policies.

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History

This policy was established in 2015.

A substantive review of the policy was conducted by IU Research resulting in substantive revisions to the policy on April 29, 2024.

A substantive review of the policy was conducted by IU Research resulting in substantive revisions to the policy on April 17, 2025.

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