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U.S. Department of Health and Human Services

Optional Stakeholder Input

Stakeholder Engagement Workshop on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

We are seeking input on the following specific questions.  Please submit your questions via e-mail to DURC@ostp.gov.

Implementation and Integration with other Institutional Oversight Activities

  1. In implementing the policy, is DURC oversight integrated with other existing institutional oversight processes in order to reduce duplication and any resulting excess administrative burdens on institutions?

Roles and Responsibilities

  1. For institutions that have registered an Institutional Biosafety Committee (IBC) with the National Institutes of Health (NIH) Office of Biotechnology Activities in accordance with the NIH Guidelines for Research Involving Recombinant DNA or Synthetic Nucleic Acid Molecules, does your IBC serve the role of the Institutional Review Entity (IRE)? Are there challenges faced by the IBC to conduct the DURC institutional review process? What are the benefits or limitations of using IBCs in this role?  If using other Institutional review entities (IREs), what challenges have been faced by your institutions’ IRE?
  2. If the IBC does not function as the IRE, what type of body serves this role at your institution?
  3. Who fulfills the role of the Institutional Contact for Dual Use Research (ICDUR), that is, the point of contact for all dual use research-related questions to and from the funding agency?  What challenges have been faced by the ICDUR in this role?

Tools and Resources

  1. The Companion Guide to this policy contains guidance and analytic tools including:
    1. Qs & As on the U.S. Government Policies for Oversight of Life Science DURC
    2. Identification and assessment of research that requires institutional review
    3. Guidance for institutions and Institutional Review Entities
    4. Developing a risk mitigation plan: Guidance for Institutional Review Entities
    5. Review of risk mitigation plans: Guidance for Institutional Review Entities
    6. Guidance for Responsible Communication of DURC findings
    7. Definitions to assist in the consideration of experimental effects
    8. Template for notifying the IRE of Research that requires institutional review
    9. Template for assessment by the IRE of research for DURC potential
    10. Template for 30 day reporting  of research that meets the scope of the Policy for Institutional DURC oversight
    11. Export Controls and DURC-guidance for institutions and Principal Investigators.

Are you using the Companion Guide? Are the tools and guidance provided by the Companion Guide helpful? Are there any additional analytic tools or guidance documents that would be useful in implementing and complying with this policy?

  1. To assist researchers and institutions in implementing and complying with the policy, a number of other education and training tools were developed. These include:
    1. 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;
    2. 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;
    3. Investigator brochure outlining the responsibilities of investigators under the September 2014 Policy; and
    4. Educational poster that may be used promote the existence of the policy and who to contact locally.

Are you using these education and training tools? Are these education and training tools helpful? Are there any additional education and training tools that would be useful in implementing and complying with this policy?

Risk Mitigation Plans

  1. The Policy requires research institutions to report the results of DURC reviews and provide risk mitigation plans for non-Federally funded research to a single Federal agency, the National Institutes of Health.  This effort is designed to foster a culture of shared responsibility for oversight of DURC and for promoting the responsible conduct and communication of such research.  Has your research institution used this approach? How does the approach function?
  2. Have you identified any challenges with developing a risk mitigation plan?

Implementation Challenges

  1. Are there other challenges (not addressed in the questions above) in implementing or complying with the institutional policy? 

  • This page last reviewed: July 22, 2015