Dual Use Research of Concern

Reportable DURC research

As noted above, PIs are required to submit research for Institutional review as soon as any of the following three criteria are met:

• The PI's research directly involves nonattenuated forms of one or more of the listed agents; or
• The PI's research with nonattenuated forms of one or more of the listed agents also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects; or
• The PI concludes that his or her research with nonattenuated forms of one or more of the listed agents that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects may meet the definition of DURC and should be considered (or reconsidered) by the IRE for its DURC potential.

Non-biological Research may be DURC

Example: Aerosol Drug Delivery:

• older generation methods for aerosol delivery of drugs to the lung were inefficient
• Engineered large porous microcarriers ("wiffle balls") that can deliver larger amounts of drugs deeper into lungs

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

Benefit: Better treatment methods for 20 million Americans with asthma

Non-Reportable DURC

Research that does not involve any of the 15 listed agents or toxins does not need to be reported to US Government agencies even it if meets the definition of DURC.

However, a risk mitigation plan will still be developed by the PI and approved by the IRE if the research meets the definition of DURC.

To initiate the institutional review process, PIs are to notify the IRE if they are conducting research that directly uses nonattenuated forms of one or more of the following agents:

• 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

It is almost universally acknowledged that life science research is fundamentally important and is the basis for advances in medicine, agriculture, environmental quality and a strong national economy.  However, over the past several years, the U.S. Government has recognized that some information generated by important life science research could be misused by those with the intent of harming public health or other aspects of national security.  This is the dual use dilemma: good science could be put to bad uses.

The NIH Office of Science Policy, in association with its Federal partners, has been actively involved in the discussion of how to best address research with this potential, known as ‘Dual Use Research of Concern, or (DURC).  In recent years, the U.S. Government has issued two policies on the oversight of DURC, both with the goal of preserving the benefits of important life sciences research while minimizing the risk that such research could be misused to cause harm.  The first Policy was issued in March 2012 and required Federal departments and agencies to review their life science research portfolios to determine if any research projects had potential DURC implications.

The second U.S. Policy, United States Government Policy for Institutional Oversight of Life Sciences DURC, was issued in September 2014.  The institutional policy outlines the procedures for the oversight of DURC at the local level and describes the responsibilities of Principal Investigators and research institutions. 

DURC Companion Guide and Additional Resources

A Companion Guide, entitled Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern, has been developed to assist institutions, investigators, and Institutional Review Entities in the development of policies and practices for the effective oversight of DURC and in the execution of some of the required steps for institutional review and oversight. Sections of the Companion Guide are intended for different audiences, depending on who is involved at different stages in the process for institutional review and oversight of DURC.

The Companion Guide’s appendices include a set of documents intended to assist institutions and others in understanding DURC and the DURC oversight policies more fully, as well as assist in the implementation of different requirements of the policies. Use of the templates provided in the appendices is completely optional, and, if used, institutions may edit and amend the templates to fit their needs. This Companion Guide will be updated, as warranted, based on the experience of institutions and USG funding agencies in implementing the Policy for Institutional DURC Oversight and the March 2012 DURC Policy.

To assist researchers and institutions in implementing and complying with the policy, a number of other education and training tools have been developed.  These include:

• Case studies which demonstrate the type of analysis that should be brought to bear during institutional reviews of DURC and highlight important administrative steps in the DURC review process;
• Training slide set which provides an overview of the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). The slides may be used to promote understanding of the issues associated with dual use research in the life sciences; highlight the importance of the need for responsible conduct and oversight of such research, and educate on the specific requirements of individuals and entities under the Policy;
• Investigator brochure outlining the responsibilities of investigators under the September 2014 Policy; and
• Educational poster that may be used promote the existence of the policy and who to contact locally.

Copies of the brochure, slides and the poster may be requested by emailing DURC@od.nih.gov.

Sensitivity regarding the potential dual use of any research should be reviewed in the context of the proper conduct of research. The Office of Biotechnology Activities (OBA) has an online Educational Tool (PDF File), developed by the National Science Advisory Board for Biosecurity that is recommend for all new scientific staff.

View a Presentation on DURC(developed by UC-Anschutz)

The National Security Advisory Board for Biosecurity (NSABB) is a federal advisory committee that addresses issues related to biosecurity and dual use research.   The NSABB does not approve the conduct of specific experiments. The NSABB advises on the development of national policies governing oversight of dual use life sciences research. At the request of the Secretary of HHS, the NSABB may review and provide guidance on experiments that exemplify a notable or novel category of dual use research or on an especially sensitive communication that may be considered dual use research of concern. For more information on the NSABB, follow the links below:

• About the NSABB
• NSABB FAQs

When a PI determines that his or her research does directly involve nonattenuated forms of one or more of these listed agents, he or she must also assess whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the experimental effects listed below, and this assessment should be provided to the institution for its consideration during the review of the research.

The categories of experimental effects are as follows:

• 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 that agent or toxin 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; and
• Generates or reconstitutes an eradicated or extinct listed agent or toxin.