Dual Use Research of Concern (DURC)

Certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes and is characterized by the United States Government (USG) as “dual use research” (DUR).  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 USG policy governing DURC, which requires the designation of an institutional review entity (IRE) or a Dual Use Research Review Committee (DURRC) to identify DURC and its associated risks and devise ways to mitigate these risks.

Dual Use Research of Concern may also necessitate Export Control review.  A project may lose its fundamental research status and become subject to US 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, would be 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), Shannon Benjamin, at shannon_benjamin@brown.edu or (401) 863-3087.

What is DURC?

A short video discussing DURC is posted on the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) website. All investigators are strongly encouraged to watch the video for a better understanding of the issues at hand.

Identifying Potential DURC

The 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

For Brown's policy on implementing DURC, please go to Brown University Policy: Dual Use Research of Concern (DURC)

Examples of DURC

Genetically modified H5N1 avian flu virus:  

  • In 2011, 2 NIH-funded research teams, one led by Yoshihiro Kawaoka at the University of Wisconsin and another led by Ron Fouchier at the Erasmus Medical Center (The Netherlands), developed methods of genetically modifying the H5N1 avian flu virus so that it can be transmitted between mammals. They submitted their papers to Nature (Kawaoka) and Science (Fouchier).  Both journals received a request from the US National Science Advisory Board for Biosecurity (NSABB) to omit certain information about the methodology and findings from manuscripts the journals were considering for publication.

  • Risk: This research resulted in the creation of what one of the principal investigators involved has called “probably one of the most dangerous viruses you can make. If made freely available, this research has the potential of being misused by terrorists or others with malevolent intentions."

  • Benefit: Research into mutations that permit the transmission of the virus in mammals may help answer important questions about the possibility of an H5N1 pandemic and contribute to more effective treatments.

Biosecur Bioterror. 2012 Sep; 10(3): 290–298

Non-biological Research may also be DURC:

  • Aerosol Drug Delivery by engineering large porous micro-carriers that can deliver larger amounts of drugs deeper into the lung.

  • Risk: Publication of the methods may allow others to use the approach for efficient delivery of anthrax or other agents as bio-weapons.

  • Benefit: Better treatment methods for 20 million Americans who suffer from asthma.

Science  20 Jun 1997:Vol. 276, Issue 5320, pp. 1868-1872

Additional Resources

Office of Science Policy Website

“Dual Use Research: A Dialogue” video

OBA Dual Use Brochure

NIH DURC Case Studies

Companion Guide to U.S. government policies for oversight of DURC

Policies & Procedures

IBC Policy on Biological Research Authorizations

Application/Renewal Biological Research Authorization (BRA) Form

BRA – Annual update, Amendment & Termination Form

Brown University Policy: Dual Use Research of Concern (DURC)

Brown University DURC Flow Chart

Required Biosafety &/or DURC Training

Principal Investigators 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 IBC oversight, appropriate training will be assigned by EHS in Traincaster

  • Refer to Section 1.11 of the BRA Form for training information.

    • Laboratory Safety Training:  Required for all individuals working in a laboratory.  Required every five (5) years.

    • Biological Safety/Bloodborne Pathogens (BBP) Training: Required for all individuals having occupational exposure to human blood, OPIM of human origin (cells/cell lines, unfixed tissues) or human BBP.  Required annually per OSHA.

    • Biological Safety/Bloodborne Pathogens (BBP) Training: Required for all individuals working with biohazard agents, toxins, and recombinant and synthetic nucleic acid molecule experiments or materials.  Required every five (5) years.

    • NIH Guidelines Training: The NIH requires training on biosafety and recombinant and synthetic nucleic acid molecules.  Required once per NIH.