As of September 24, 2015, all institutions and U.S. Government 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 support of implementation, the U.S. Government 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.