Dual Use Research of Concern (DURC) Institutional Review Entity

The Dual Use Research of Concern Institutional Review Entity (DURC-IRE) was established to implement internal policies and practices that provide for the identification and effective oversight of DURC and Pathogen of Pandemic Potential (PPP) within the NIH Intramural Research Program. The DURC-IRE committee will be the NIH authoritative review body for any research that may meet the definition of DURC after review by any of the IBCs and shall review all projects including the 15 agents as outlined in the USG policy, as well as research that may create a PPP. The DURC-IRE is composed of at least 5 voting members as designated by the ICDUR. The committee includes persons with knowledge of relevant USG research and DURC-related policies, understanding of risk assessment considerations, and biosafety and biosecurity practices. For the review of new research proposals involving DURC and/or PPP, the voting members of the committee shall include:

• Director, Division of Occupational Health and Safety (ICDUR)
• Deputy Director for Intramural Research (Chairperson)
• Director of Research Integrity, and Agency Intramural Research Integrity Officer (AIRIO)
• Chair, NIH Occupational Safety and Health Committee
• Scientific Director, NIAID
• Scientific Director (rotation between all IC’s within IRP; 2-year terms)
• Clinical Director (rotation between all IC’s within IRP; 2-year terms)
• NIH Biological Safety Officer, Bethesda
• NIH Biological Safety Officer, Hamilton

An IRE member will recuse themselves from review, or vote upon, an action in which the member has a conflicting interest including when they are listed as a member of a research project, are a family member of someone on the research team, or if they have a financial conflict of interested with the research. Members shall also recuse themselves under circumstances not specifically listed above if they feel they cannot perform an unbiased review. For meetings, members may elect a designee (if necessary) and may request an ‘ad hoc’ subject matter expert(s) be included for the discussion. Ad hoc members may be selected from among the NIH research community at large and will include persons with relevant expertise to assess dual use potential of the range of life sciences research conducted at the NIH. At least five members (or designees) must be present for quorum. In addition to the voting membership, the following ‘Ex Officio’, non-voting members, may participate in the discussion portion of the meeting:

• Office of Security and Emergency Response
• NIH Office of General Counsel
• NIH Office of Communications and Public Liaison
• Principal Investigator (PI) of the proposed study
• Scientific Director from sponsoring Institute
• IBC Chair from specific location where research is being proposed
• Biological Safety Officer from location, if other than Bethesda or Hamilton
• Responsible Official (if applicable) from location where research is being proposed