Policy Program

Integrity & Compliance Office

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Dual Use Research of Concern in the Life Sciences (DURC)

Responsible Office: Research and Innovation
Current Approved Version: 02/25/2020
Policy Type: Administrative

Policy Statement and Purpose

This policy is to establish VCU’s review and oversight of all research (regardless of the source of funding) that qualifies as dual use research of concern (DURC). The fundamental aim of DURC review is to preserve the benefits of life sciences research while mitigating the risk of misuse of the knowledge, information, products, or technologies provided by such research where appropriate and as required by federal regulation.

In order to meet the requirements of the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, VCU has established an Institutional Review Entity (IRE), a subcommittee of VCU’s Institutional Biosafety Committee (IBC), that will have the responsibility and authority to review all research projects involving the agents and toxins identified by the USG to have DURC potential and to direct the Institutional Contact for Dual Use Research (ICDUR) to report those projects to the USG. The IRE in collaboration with the USG has the authority to establish ongoing review procedures and may place certain restrictions, up to and including a moratorium (when required by the USG), on research found to be DURC.

In addition to the institutional review and oversight detailed in this policy, each principal investigator (PI) whose research qualifies as DURC is required to communicate with the IRE and comply with the procedures set forth in this policy as well as any additional procedures established by VCU’s IRE or the USG. The IRE will also accept gain of function (GOF) research review requests from other review committees or employees.

Deans, department chairs, directors, managers, PIs, laboratory managers, and those with supervisory authority are ultimately responsible for ensuring that work or research is conducted within the requirements of this policy.

Noncompliance with this policy may result in disciplinary action up to and including termination. VCU supports an environment free from retaliation. Retaliation against any employee who brings forth a good faith concern, asks a clarifying question, or participates in an investigation is prohibited.

Who Should Know This Policy

All university employees (including faculty) conducting or overseeing research that qualifies as DURC are responsible for knowing this policy and familiarizing themselves with its contents and provisions.

Definitions

Dual Use Research

As defined by the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, “Research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes.”

Dual Use Research of Concern (DURC)

As defined by the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, “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[sic], or national security.”

Gain of Function (GoF)

As defined by the U.S. Department of Health and Human Services, this refers to any modification of a biological agent that confers new or enhanced activity.

Institutional Contact for Dual Use Research (ICDUR)

The individual designated by the university to be the institutional point of contact for questions relating to compliance with this policy and the liaison with the relevant USG funding agencies. The senior associate vice president for research compliance serves as VCU’s ICDUR.

Institutional Review Entity (IRE)

The subcommittee established by this policy and drawing its membership from practicing scientists, safety and research experts, VCU’s attending veterinarian, and other experts, which is the final authority on the risk analysis of potential DURC and any relevant risk mitigation plans.

Life Sciences

As defined by the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, a field of study that “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, synthetic 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 for understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules.”

Principal Investigator (PI)

The individual with overall responsibility for the conduct of research or other activity described in a proposal, protocol, or an award, and/or the individual with fiduciary responsibility for award management.

Risk Mitigation Plan

A written plan developed by the PI, the IRE, and the USG to mitigate any DURC-related risk.

Contacts

The Office of the Vice President for Research and Innovation officially interprets this policy. The Export Compliance Program is responsible for obtaining approval for any revisions as required by the policy Creating and Maintaining Policies and Procedures through the appropriate governance structures. Please direct policy questions to the Institutional Biosafety Committee at ibc@vcu.edu. Questions regarding this policy also may be sent to the director of the Export Compliance Program.

Policy Specifics and Procedures

Investigator Responsibilities:

1. Initial Assessment of Potential DURC: Before commencing research activities, any person employed by VCU that is conducting research with one or more potential DURC agents or toxins must complete an initial assessment to determine whether any such agent or toxin produces, aims to produce, or can be reasonably anticipated to produce one or more of the effects listed in the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern list of Categories of Experiments. Persons responsible for complying with this policy must consult the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern directly for the most accurate information.

Potential DURC Agents and Toxins (USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern § 6.2.1):

Avian influenza virus (highly pathogenic)
Bacillus anthracis
Botulinum neurotoxin (in any quantity)
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

Categories of Experiments (USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern § 6.2.2):

Enhances the harmful consequences of the agent or toxin
Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against the agent or toxins or facilitates their ability to evade detection methodologies
Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
Alters the host range or tropism of the agent or toxin
Enhances the susceptibility of a host population to the agent or toxin
Generates or reconstitutes an eradicated or extinct agent or toxin previously listed above

2. IRE Notification of Potential DURC: The PI must submit the Internal DURC Report Form along with the PI’s initial assessment to the IRE at least 10 business days before initiating any research that may be qualified as DURC.

The IRE can be reached through

Senior Associate Vice President for Research Compliance and Administration
804-827-0479 or ibc@vcu.edu

3. Risk Mitigation: If the IRE determines that the proposed research is DURC, the PI must:

Collaborate with the IRE to develop a risk mitigation plan;
Conduct research in accordance with the risk mitigation plan;
Notify the IRE of any substantive change in the ongoing conduct of the research;
Ensure that all laboratory personnel conducting research with one or more of the listed agents or toxins has received and documented education and training on DURC and any relevant risk mitigation plan.
Communicate DURC in a responsible manner and ensure that communication is in compliance with the approved Risk Mitigation Plan.

4. Ongoing Review:

a. The PI must assess their research for DURC potential on an ongoing basis (i.e., throughout the research process from project conception through application for funding, submission of progress reports, and communication of the research findings) and notify the VCU IRE if any DURC concerns arise. If the PIbelieves that the research should no longer be considered DURC, the PI can request a review of the risk mitigation plan.

5. Annual Report:

A PI with a DURC risk mitigation plan in place must submit an updated Internal DURC Report Form annually to the IRE.

Institutional Responsibilities:

1. IRE Verification of DURC:

The IRE will review the PI’s initial assessment to verify any determination of DURC and conduct appropriate risk assessment.

2. Risk Mitigation Plan Development and Implementation: Upon completion of the risk assessment (whether or not anticipated research is determined to be DURC), the IRE will coordinate through the ICDUR with the PI, and the USG to develop and implement an appropriate risk mitigation plan according to the source of research funding as set forth below.

IRE Procedures for USG Funded Research
1. The IRE will direct the ICDUR to notify the appropriate USG funding agency of the outcome of the review within 30 calendar days.
2. If the research requires DURC oversight, the IRE considers the previously identified risks and the anticipated benefits in order to develop a draft risk mitigation plan.
3. The IRE works with the USG funding agency, through the ICDUR, toward completing the draft risk mitigation plan within 90 calendar days of the IRE’s determination that the research is DURC.
4. Once the USG funding agency finalizes the risk mitigation plan (generally within 60 calendar days of receipt of the draft plan), the PI and the IRE implement the approved risk mitigation plan and provide ongoing oversight of DURC.
5. Risk mitigation plans must include a requirement for the PI to submit an annual update via an IRE Review Submission Form.
IRE Procedures for Non-USG Funded Research
1. The IRE will direct the ICDUR to notify the NIH Program on Biosecurity and Biosafety Policy within 30 calendar days of identifying any non-USG funded research as DURC. The NIH will provide the ICDUR with further direction on the appropriate government agency to collaborate with on developing a risk mitigation plan.
2. Risk mitigation plans must include a requirement for the PI to submit an annual update via an Internal DURC Report Form.
3. Contact information for NIH:
  Program on Biosecurity and Biosafety Policy
  Office of the Director
  National Institute of Health
  Phone: 301-496-9838
  Email: DURC@od.nih.gov

3. ICDUR Responsibilities:

Ensure that the USG is appropriately notified of IRE reviews per this policy
Ensure that the IRE is informed of any USG requests or orders made to the IRE or the PI
Ensure the PI receives the appropriate education and training as outlined by the IRE and USG in a risk mitigation plan
Maintain records of institutional DURC reviews, established risk mitigation plans, and follow up DURC reviews
Notify the USG within 30 calendar days of any change in the status of any DURC project including a determination by the IRE that the project is no longer DURC. Notification must include any changes to an approved risk mitigation plan.
Ensure that any changes to an approved risk mitigation plan are approved by the USG.
Report within 30 calendar days to USG any issues of noncompliance identified by VCU’s IRE

4. Ongoing DURC Review:

The IRE will review each DURC mitigation plan annually by comparing the original plan with any changes in the PI’s updated Internal DURC Report Form. If the research has changed and the risk mitigation plan must be updated the IRE must direct the ICDUR to notify the USG of the plan changes and receive approval from the USG.

5. Training and Communication:

The IRE will ensure that education and training approved as part of the risk mitigation plan is available and will direct the ICDUR to monitor training and retain records for individuals who are conducting research with one or more DURC agents.
If the IRE receives notification from the USG it will direct the ICDUR to notify the PI if the USG requests voluntary redaction of research publications, classifies the research or terminates funding.

Forms

1. Internal DURC Report Form

Revision History

09/17/2015	Dual Use Research of Concern (DURC) – Interim
01/23/2017	Dual Use Research of Concern (DURC) (04/27/2017 - minor revision to remove “interim” from initial approval date)
01/23/2017	Dual Use Research of Concern in the Life Sciences

FAQ

What if I have questions about DURC or this policy?

Questions relating to this policy or DURC should be posed to the Institutional Biosafety Committee at ibc@vcu.edu.
What forms must be submitted to the Office or Research and Innovation prior to beginning a research project involving agents or toxins of dual use concern?

Prior to beginning any potential DURC research, the PIs must submit a completed Internal DURC Report Form to the Institutional Biosafety Committee (ibc@vcu.edu).
Does the designation of DURC mean the research should not be published or conducted?

Answer: No. A determination that research is DURC, in and of itself, does not mean that the research should not be published or conducted. Research that is categorized as DURC is often vitally important to science, public health, and agriculture, and its findings contribute to the broader base of knowledge that advances science and public health objectives. Upon identifying research as DURC, institutions should give careful thought to the ways in which the research or its results might be misused and the mitigation measures that can be put in place to minimize the possibility of misuse.
Where can institutions and investigators find more information about DURC and the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern?

Information about dual use research in the life sciences in general, as well as specific details on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, is available on the USG Science, Safety, Security (S3) website: http://www.phe.gov/s3/dualuse/Pages/default.aspx