Dual use research of concern (DURC) is a subset of dual use research, and is defined as: “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, material or national security.” 

As a recipient of federal funds, Brown must comply with U.S. policy governing DURC, which requires the designation of an institutional review entity or a DURC review committee to identify DURC and its associated risks and devise ways to mitigate these risks. At Brown, the Institutional Biosafety Committee (IBC) screens for DURC through applications submitted to the committee. Principal investigators (PI) must notify the IBC if they plan to conduct research that directly uses nonattenuated forms of any one of the listed agents. 

U.S. government policy characterizes both the PI and the IBC as responsible parties for identifying potential DURC.

• Institutional Biosafety Committee (IBC)
• Biological Research Authorization (BRA) Application (PDF)

Dual use research of concern (DURC) may also necessitate export control review. A project may lose its fundamental research status and become subject to U.S. export control regulations if, under DURC policy, the release of the informational results and/or technology become limited or restricted. 

Any DURC effort that creates or produces biological agents or biologically derived substances capable of producing casualties in humans or livestock, degrading equipment or damaging crops, and which have been modified for the specific purpose of increasing such effects, is subject to the very restrictive International Traffic in Arms Regulations.

Questions or requests for additional information should be directed to the Institutional Contact for Dual Use Research (ICDUR), part of the Research Integrity team.

The DURC review process begins with the identification of research that directly involves one or more of 15 listed agents (the “DURC list”):

• 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

The Institutional Biosafety Committee (IBC) has developed eight screening questions that are incorporated into the Biological Research Authorization (BRA) application. Prior to the development of this policy, Brown used the DURC IBC Notification Form to identify potential DURC.

The formal review of potential DURC is initiated by researchers responding to the eight questions in the IBC BRA application, which is required for research involving all recombinant DNA (rDNA) and infectious materials, and continues with further review by the Dual Use Research Review Committee (DURRC) if the answer to any of the following screening questions is yes. Brown may also utilize an external DURRC if needed.

The questions ask the investigators to indicate whether the proposed research is designed to do any of the following:

1. Enhance the harmful consequences of a biological agent or toxin
2. Disrupt immunity or effectiveness of an immunization without clinical and/or agricultural justification
3. Confer to a biological agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against the agent or toxin
4. Facilitate their ability to evade detection methodologies
5. Increase the stability, transmissibility or ability to disseminate a biological agent or toxin
6. Alter the host range or tropism of a biological agent or toxin
7. Enhance the susceptibility of a host population
8. Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent

The DURRC must consist of at least five members and must include among them the IBC chair, Director of Research Integrity and Biosafety Officer. A subset of the Brown IBC may be used as the DURRC, depending on their expertise, as well as other members of the Brown community designated by the Associate Vice President for Research.

The DURRC could also consist of any other of the following members of the Brown community: a representative of the Risk Management Committee, the chief of Brown DPS, the Associate Provost for Research, a community member, a representative from University Communications, and representatives of the scientific community with related expertise.

Scientific representatives, the chair of the IBC, and safety specialists will form the subcommittee conducting the Stage I review. The University may also utilize an outside ad hoc DURRC depending upon the expertise needed for review.

DURCC Meetings

The DURRC will meet when the preliminary questionnaire, from the IBC BRA, indicates that a study might be subject to DURC review, or if the IBC refers a study to be reviewed internally for DURC. The full committee will be kept abreast of the latest recommendations of National Science Advisory Board for Biosecurity (NSABB) or other advisory or regulatory bodies, and determine whether any modifications to the oversight program are required.

The committee will maintain two minutes of its deliberations and communicate its management recommendations for oversight to the PI in writing.

Each research initiative that is categorized as dual-use research or DURC is different and poses unique issues related to the implications of the information, materials or technologies that may result from the research. Therefore, it is not possible to develop a single review process that can be used for all cases. However, NSABB has developed a toolkit for such reviews that provides guidance for a comprehensive process. The Brown DURRC will perform its reviews based on these guidelines. 

The framework for risk assessment and risk mitigation follows a multistep process: 

• Step 1: Verify that the research directly involves nonattenuated forms of one or more of the listed agents.   
• Step 2: Assess whether the research produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects.  
• Step 3: Assess the risks of dual use and determine whether the research is DURC. For research the committee determines to be DURC:  
• Step 4: Assess the potential benefits of the DURC.  
• Step 5: Weigh the risks and benefits of the DURC.  
• Step 6: Develop a draft risk mitigation plan for conducting the DURC and communicating its findings (described in detail in Section D of the DURC Companion Guide published by the National Institutes of Health (NIH).

Risk mitigation plans should provide sufficient details on the research in question to enable the federal funding agency to adequately assess the institution’s plan for managing the risks associated with DURC identified by the committee.  

The Brown DURRC will work closely with the U.S. government funding agency (or, for nonfederally funded DURC, the NIH-designated government agency) to develop the draft risk mitigation plan.   

Risk mitigation plans should include the following:  

• The name and contact information for the PI(s)
• The name and contact information for the authorized institutional official or their designee
• The dates and details of the reviews and assessments of the research by the IBC
• The dates and details of the PI’s initial review or ongoing assessment of the research.  Identification of whether the research has been identified as DURC under the March 2012 DURC Policy 
• Details of the risks identified by the IBC in its review of the research, and an explanation of the risk mitigation strategy or strategies that are being implemented by the institution to address those risks
• Other materials, such as proposals and progress reports related to the research that may be requested by the U.S. government agency

The University must submit a copy of the draft risk mitigation plan within 90 calendar days of the committee’s determination that the research is DURC to the designated federal agency for review and final approval. Federal agencies are required to provide an initial response to institutions within 30 calendar days and should finalize the plan within 60 calendar days of receipt of the draft plan.

• Office of Science Policy Biosafety and Biosecurity Policy
• NIH DURC Case Studies
• NIH Companion Guide to U.S. DURC Policies
• Brown University DURC Flowchart (PDF)

Principal Investigators (PIs) and any lab personnel working on DURC projects or any projects requiring biosafety training are required to complete all assigned training before approvals are granted by the responsible oversight committee(s). Once a protocol is identified as requiring Institutional Biosafety Committee oversight, appropriate training will be assigned by Brown Environmental Health and Safety in Traincaster.

For information about required training, refer to Section 1.11 of the Biological Research Authorization Form.

Environmental Health and Safety Training