Dual Use Research of Concern
Dual use research of concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misused to pose a significant threat with broad consequences to public health and safety, agricultural crops and other plants, animals, the environment, or national security.
United States Government Policy for Institutional Oversight of Life Sciences DURC
On September 24, 2014, the USG released the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The policy addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication of DURC.
This Policy and the March 2012 DURC Policy are complementary and emphasize a culture of responsibility by reminding all involved parties of the shared duty to uphold the integrity of science and prevent its misuse. Like the March 2012 DURC Policy, the scope of this Policy is limited to a well-defined subset of life sciences research that involves 15 agents and toxins and seven categories of experiments. The USG will solicit feedback on the experience of institutions in implementing the Policy; evaluate the impact of DURC oversight on the life sciences research enterprise; assess the benefits and risks of expanding the scope of the Policy to encompass additional agents and toxins and/or categories of experiments; and update the Policy as warranted.
Research institutions are encouraged to be mindful that research outside of the scope articulated in this Policy may also constitute DURC. Institutions have the discretion to consider other categories of research for DURC potential and may expand their internal oversight to other types of life sciences research as they deem appropriate, but such expansion would not be subject to oversight as articulated in this Policy.
United States Government Policy for Oversight of Life Sciences DURC
On March 29, 2012, the USG released the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (“March 2012 DURC Policy”) This action established a USG policy for DURC as applied to a well-defined subset of life sciences research that involves 15 agents and toxins and seven categories of experiments and established regular review by Federal agencies of USG-funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern. The intent of this Policy is to: (a) mitigate risks where appropriate, and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
NEW! Deliberative Process and Funding Pause on Certain Types of Gain-of-Function Research
On October 16, 2014, the White House announced that the U.S. Government will launch a deliberative process in order to assess the risks and benefits of certain gain-of-function (GOF) experiments. During this deliberative process, U.S. government departments and agencies will pause the release of federal funding for GOF studies that enhances the pathogenicity or transmissibility among mammals by respiratory droplets of influenza, MERS, or SARS . The pause will allow the U.S. Government, in partnership with the life sciences community and stakeholders, to conduct a comprehensive assessment of gain-of-function research with the explicit goal of developing a new federal policy framework to guide future investments in this area of research.
Department of Health and Human Services Framework on H5N1 DURC Research
The Department of Health and Human Services (HHS) has also released additional guidance on a particular subset of potential DURC. For over a decade, highly pathogenic avian influenza (HPAI) H5N1 virus has been recognized as a threat to agriculture and human health. Research on this virus is important for understanding if the virus could evolve to become more readily transmissible among mammals, including humans, and for the development of countermeasures to prepare for this possibility. In February 2013, HHS developed a Framework for Guiding Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets to guide funding decisions on proposals for research anticipated to generate HPAI H5N1 viruses that are transmissible by respiratory droplets among mammals.
The new Framework outlines a robust review process that takes into account the scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures pertinent to the proposed research. Development of the Framework was important because of the safety and security concerns raised by experiments that aim to generate mammalian-transmissible HPAI H5N1 strains. The Framework will allow for the most informed decisions possible about whether and how to support and conduct this research.In August 2013, the Framework was expanded to cover certain types of gain-of-function experiments involving H7N9 influenza virus, as described in the August 16, 2013 edition of Science magazine. Research investigators with questions about how the Framework may apply to their research are encouraged to contact the program officer at their funding agency.
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.
- 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.