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.
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.
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.
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.
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 email@example.com. Questions regarding this policy also may be sent to the director of the Export Compliance Program.
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):
Categories of Experiments (USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern § 6.2.2):
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
3. Risk Mitigation: If the IRE determines that the proposed research is DURC, the PI must:
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:
1. IRE Verification of DURC:
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
IRE Procedures for Non-USG Funded Research
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.
Risk mitigation plans must include a requirement for the PI to submit an annual update via an Internal DURC Report Form.
Contact information for NIH:
Program on Biosecurity and Biosafety Policy
Office of the Director
National Institute of Health
3. ICDUR Responsibilities:
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.
United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern)
Dual Use Research of Concern (DURC) – Interim
Dual Use Research of Concern (DURC)
Dual Use Research of Concern in the Life Sciences