Dual Use Research of Concern Policy

Title

Dual Use Research of Concern Policy

I. Introduction and Purpose

In 2014, the United States Government implemented the Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (hereinafter “Federal DURC Policy”) overseeing research which 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 purpose of this policy (“Policy”) is intended to ensure The University of North Carolina at Chapel Hill’s (the “University’s”) compliance with the Federal DURC Policy by strengthening the institutional review and oversight of certain research to identify potential Dual Use Research of Concern (DURC) and to develop and implement risk mitigation where appropriate.

II. Policy Statement

This Policy seeks to preserve the benefits of life sciences DURC at the University while minimizing the risk that the knowledge, information, products, or technologies generated from such research could create the potential negative consequences identified in the Federal DURC Policy. All research conducted at the University involving DURC Agents (as defined in Section III. below) is subject to this policy, regardless of the source of funding.

III. Definitions

1. “Dual use research” is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes.
2. “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.
3. “DURC Agents” include the following 15 biological agents and toxins referred to in the Federal DURC Policy, Section 6.2.1:
   • Avian influenza virus (highly pathogenic)
   • Bacillus anthracis
   • Botulinum neurotoxin*
   • Burkholderia mallei
   • Burkholderia pseudomallei
   • Ebola virus
   • Foot-and-mouth disease virus
   • Francisella tularensis
   • Marburg virus
   • Reconstructed 1918 Influenza virus
   • Rinderpest virus
   • Toxin-producing strains of Clostridium botulinum
   • Variola major virus
   • Variola minor virus
   • Yersinia pestis

   * The Federal DURC Policy contains no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential.

4. “Experimental Effects of Concern” include the following seven categories of experiments defined in the Federal DURC Policy, Section 6.2.2:
   1. Enhances the harmful consequences of the agent or toxin
   2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
   3. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
   4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
   5. Alters the host range or tropism of the agent or toxin
   6. Enhances the susceptibility of a host population to the agent or toxin
   7. Generates or reconstitutes an eradicated or extinct agent or toxin listed in 6.2.1.
5. “Institutional Contact for Dual Use Research” (ICDUR) is the individual designated by the University to serve as an institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of DURC as well as the liaison (as necessary) between the University and the Appropriate USG Agency. At the University, the Executive Director of Environment, Health and Safety functions as the ICDUR.
6. “Institutional Review Entity” (IRE) is a subcommittee of the University’s Institutional Biosafety Committee (IBC) established by the University and empowered to verify if a project constitutes DURC, assess the risks associated with research proposals and reviews and approves the associated risk mitigation plans.
7. “Life sciences” pertains to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, microbiology, synthetic biology, virology, molecular biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches to understanding life at the level of ecosystems, populations, organisms, organs, tissues, cells, and molecules.
8. “Principal Investigator” (PI) is an individual who is designated by the University to direct a project or program and who is responsible to the Appropriate USG Agency or the University for the scientific and technical direction of that project or program. There may be more than one PI on a research grant or project within a single or multiple institution(s).
9. “USG Funding Agency” is the United States government (USG) agency that is funding the subject research or, if the research is not USG-funded, the USG agency designated by the NIH, based on the nature of the research. If a federal department or agency simply passes through funding from another federal department or agency to support life sciences research involving one or more of the DURC Agents, the agency originally providing the funding shall be considered the US Funding Agency.

IV. Audience

This Policy is applicable to all University personnel involved in the conduct or oversight of life sciences research.

V. Compliance

Non-compliance with the Federal DURC Policy may result in suspension, limitation, or termination of USG funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the University, consistent with existing regulations and policies governing USG funded research and may subject the University to other potential penalties under applicable laws and regulations.

VI. Scope

The scope of this Policy is limited to research that uses one or more of the agents or toxins listed in Section III.C. “DURC Agents” and involves any experimental effects as defined in Section III. D. “Experimental Effects of Concern."

VII. University Responsibilities

1. The University shall be responsible for implementation and periodic review of internal procedures and practices, detailed in this Policy, that provide for the identification and effective oversight of DURC.
2. The University shall appoint the Institutional Contact for Dual Use Research (ICDUR) who serves as the institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of DURC research The ICDUR serves as the liaison between the University and the relevant program officers at the Appropriate USG Agency.
3. The University shall establish an Institutional Review Entity (IRE) that is composed of at least five members with sufficient breadth of expertise to assess the dual use potential of the range of relevant life sciences research conducted at the University. IRE membership must include personnel with knowledge of relevant U.S. government policies and understanding of risk assessment and risk management considerations, including biosafety, biosecurity, and export controls. The IRE may also include, or have available as consultants, at least one person knowledgeable in the University’s commitments, policies, and standard operating procedures. The minimum membership of the University’s IRE will be comprised of the ICDUR, the EHS Biological Safety Officer, the Chair of the IBC, a Principal Investigator with expertise in microbiology and other members of the IBC as appropriate. On a case-by-case basis, any member of the IRE who is involved in the research project in question or has a direct financial interest in such research, shall be recused except to provide specific information requested by the IRE. A minimum quorum of three committee members in addition to the ICDUR and the Biological Safety Officer must be present to convene a meeting of the IRE.

VIII. Principal Investigator Responsibilities

1. A Principal Investigator (PI) must notify the IRE by submitting for review any anticipated or proposed research that meets any of the following criteria:
   1. The PI’s research involves nonattenuated forms of one or more of the DURC agents.
   2. The PI’s research with nonattenuated forms of one or more of the DURC agents or toxins also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven experimental effects listed in this Policy.
   3. The PI concludes that their research may meet the definition of DURC.

   The PI notification must include the PI’s assessment of whether any research involving these agents or toxins produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed in Section III.D. of this Policy. The PI must not perform any research activities related to potential DURC until the IRE has reviewed and approved.

2. The PI works with the IRE to assess the dual use risks and benefits of the DURC and to develop risk mitigation measures.
3. PI conducts DURC in accordance with the provisions in the risk mitigation plan.
4. PI must be knowledgeable about and comply with all University and USG policies and requirements for oversight of DURC.
5. PI must ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) have received and documented education and training on DURC.
6. The PI communicates about DURC in a responsible manner. Communication of research and research findings is an essential activity for all researchers, and occurs throughout the research process, not only at the point of publication.

IX. Requirements of Institutional Review

This Policy designates the IRE as the body responsible for executing the institutional review of potential Dual Use Research of Concern.

A. Process for Identifying DURC

When University research is identified as DURC, the IRE shall initiate a review and oversight process that includes the steps below, as applicable.​​​​​​

1. Queries on EHS/IBC forms for reviewing research with biological materials include questions which act as a prompt to assess research activities for DURC potential.
2. If the initial assessment that certain University research potentially falls within the scope of this Policy is made by the ICDUR, Biological Safety Officer, or the IBC, the Biological Safety Officer will notify the PI of the impending IRE review of the research and the PI’s obligations under Section VIII of this Policy.
3. The IRE shall verify that the research identified by the PI utilizes one or more nonattenuated forms of DURC agents.

B. IRE Review Process

1. The IRE shall review the PI’s risk assessment of whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed and determines their applicability.
2. If the IRE determines that the research in question does not involve one or more of the categories of experiments, the research is not subject to additional review or oversight but shall continue to be assessed by the PI. If there is a change in this research such that it can be reasonably anticipated to produce one or more of the seven listed experimental effects, the PI should notify the IRE and supply a revised assessment.
3. If the IRE determines that the research in question does not meet the definition of DURC, the research is not subject to additional DURC oversight. The ICDUR shall notify the Appropriate USG Agency of the IRE findings.
4. If the IRE determines that the research in question meets the definition of DURC, the IRE will inform the PI of its findings and provide the PI an opportunity to appeal the institutional decision. Research identified by the IRE as meeting the definition of DURC shall not commence until all the additional review and oversight steps in the following subsections below have been accomplished.
5. Within 30 calendar days of the institutional review of the research for DURC potential, the ICDUR shall notify the appropriate USG Agency of any research that involves one or more of the 15 listed agents and one or more of the seven listed experimental effects (Section 6.2 of the Federal DURC Policy), including whether it meets or does not meet the definition of DURC.

C. Development of Mitigation Plan

1. The IRE shall identify the anticipated benefits of the research identified as DURC. The anticipated benefits should be considered in conjunction with the previously identified risks in order to develop a draft risk mitigation plan to guide the conduct and communication of the DURC. A Template Risk Mitigation Plan is on file with EHS. (Please see Appendix A of this Policy.) The IRE should work with both the PI and Appropriate USG Agency to develop a risk mitigation plan.
2. Within 90 calendar days of an IRE’s determination that the research is DURC the ICDUR shall provide a draft risk mitigation plan based on the thorough assessment of the risks and benefits of the research to the Appropriate USG Agency for final review and approval. USG agencies must provide an initial response within 30 calendar days and should finalize the plan within 60 calendar days of receipt of the draft plan.
3. After a risk mitigation plan is developed and is approved by the Appropriate USG Agency, the Principal Investigator is responsible under Section VIII C. of this Policy to conduct the relevant DURC in accordance with that plan. The IRE shall review, at least annually, all active risk mitigation plans. If the research in question still constitutes DURC, the IRE should work with the PI to modify the plan as needed.
4. The IRE shall notify the Appropriate USG Agency, within 30 calendar days:
   1. any change in the status of a DURC project at the University (including whether the research is determined by the IRE to no longer meet the definition of DURC), and
   2. details of any changes to risk mitigation plans (as such changes are subject to approval by the funding agency).
5. In cases of collaborations involving multiple institutions via a sub award, the primary institution on the award is responsible for the DURC oversight described in this Section B including notifying the Appropriate USG Agency of research that falls within the scope of Section 6.2 of the Federal DURC Policy and, if that research is determined to be DURC, providing copies of each collaborating institution's risk mitigation plan. Furthermore, the primary institution shall ensure that DURC oversight is consistently applied by all entities participating in the collaboration.

D. Additional Institutional and IRE Responsibilities

1. The IRE shall maintain records of its DURC reviews and completed risk mitigation plans for the term of the research grant or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.
2. IRE Meeting minutes will be taken, reviewed, and approved by committee members, and maintained on file with EHS.
3. The University shall provide education and training on DURC for individuals conducting life sciences research and maintain records of such education and training for the term of the research grant or contract plus three years after its completion.
4. The ICDUR, will report instances of noncompliance with the Federal DURC Policy, as well as mitigation measures undertaken by the University to prevent recurrences of similar noncompliance, within 30 calendar days to the Appropriate USG Agency.
5. As necessary, the IRE shall assist the PIs conducting life sciences research when questions arise about whether their research may require further review or oversight.
6. The University’s Vice Chancellor for Research shall review any appeal by a PI of IRE decisions or any other University decision regarding research that is determined by the IRE to meet the definition of DURC. The Vice Chancellor for Research shall provide a final ruling on the appeal.
7. The IRE shall make information about the process for review of research subject to the Federal DURC Policy available upon request, as consistent with applicable law.
8. When applying for or accepting USG funds for life sciences research, as applicable, the University shall certify that the University will be or is in compliance with all aspects of the Federal DURC Policy.

IX. Related Regulations, Statutes, and Related Policies

• United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern was released on September 24, 2014 and took effect on September 24, 2015.
• United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern was released on March 29, 2012 and serves as a complement to the Federal DURC Policy for Institutional Oversight (2014).

X. Contacts

XI. Document History

Revisions

• December 2021
• January 2018

Effective Date

• August 1, 2015