Dual Use Research of Concern
NEW! Implementation Deadline for the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern: September 24, 2015
As of September 24, 2015, all institutions and USG funding agencies subject to the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern must comply with all the requirements listed therein. All institutions subject to the Policy must now have a mechanism in place to evaluate research that is potentially Dual Use Research of Concern (DURC). Institutions subject to the Policy must also have an established Institutional Review Entity (IRE). The IRE assesses the risks and benefits associated with research conducted by the institution, identifies DURC as described in the Policy, and works with the principal investigator and funding agency to develop a risk mitigation plan, when appropriate. If the IRE determines that Federally-funded research has DURC potential, the institution must notify the funding Agency listed on the award within 30 days. For non-Federally funded research determined to be DURC, the IRE should refer the project to NIH by emailing DURC@od.nih.gov. For any additional questions, please contact the program officers at the appropriate funding Agency or DURC@ostp.gov.
In advance of the implementation deadline, the USG has developed two additional resources for institutional stakeholders.
- Points to Consider When Using an IBC as an IRE - One of the primary responsibilities of an institution under the Policy is to establish an Institutional Review Entity (IRE) responsible for reviewing research subject to the scope of the Policy. Since many of the institutions that will be subject to the Policy already have an established Institutional Biosafety Committee (IBC), there is a possibility that some institutions will use their IBC to also act as their IRE. While it is acceptable to have an IBC assume IRE responsibilities, institutions should consider the unique set of responsibilities of an IRE when using this oversight model.
- DURC Stakeholder Meeting Summary: Addressing Key Issues - Several important questions and issues were raised during the stakeholder workshop; the three most prevalent are addressed in the attached document.
Summary of the Stakeholder Engagement Workshop on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
The White House Office of Science and Technology Policy and the National Institutes of Health co-hosted a public workshop on July 22, 2015, for interested stakeholders to discuss implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The workshop was well attended by both domestic and international stakeholders, including nearly 200 registered participants in person and on the webcast. The diverse group of participants from all levels of institutional DURC oversight facilitated a broad and thorough discussion of the Institutional DURC policy. For more information and access to resources from the workshop, please see the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern Stakeholder Engagement Workshop Summary.
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. To learn more, see the Frequently Asked Questions on the U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses.
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.
A hypothetical case study was presented at the July 22, 2015 Stakeholder Engagement Workshop for the USG Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern. The case study illustrates the considerations that must be taken into account as investigators and Institutional Review Entities (IREs) consider whether research is subject to the USG policy for institutional oversight of DURC, and whether particular experiments or lines of research may constitute DURC. The case study focuses on Francisella tularensis spp. In the United States, research activities are primarily conducted in Biosafety Level 3 conditions and F. tularensis spp. include strains that are subject to and exempt from Federal Select Agent Regulations, based on protocol specific biological risk assessment. The case study is illustrative only, and may not reflect the existing technical knowledge base.
There is no intentional representation of, or connection to, real persons, institutions, or research protocols by the U.S. Government.
The case study exercise should:
- Illustrate the iDURC review process
- Promote a collaborative environment between USG funding agencies, research institutions, and life scientists
- Facilitate interactive exchange and learning for all participants
- Clarify the roles and responsibilities of the institution, the USG funding agency, the Institutional Contact for Dual Use Research, the Institutional Review Entity, and the Principal investigator
- Emphasize a culture of responsibility for oversight of DURC and for promoting the responsible conduct and communication of such research
The case study and supporting moderator tools are linked here for use as an educational tool: