Institutional Review Entity (IRE)
UTA will establish an IRE to execute the requirements of the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. UTA may utilize one or more of the following options, based on the nature of the activities and expertise available: (1) a committee established for dual use review; (2) an extant committee (such as an Institutional Biosafety Committee [IBC]) whose constitution meets or could meet, with the addition of new or ad hoc members, the requirements and attributes outlined below; or (3) an externally administered committee (e.g., an IBC or review entity at a neighboring or regional institution or a commercial entity).
The IRE will be composed of at least five members and:
- Be sufficiently empowered by the institution to ensure it can execute the requirements of USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern;
- Include persons with sufficient breadth of expertise to assess the dual use potential of the range of relevant life sciences research conducted at a given research facility;
- Include persons with knowledge of relevant USG policies and understanding of risk assessment and risk management considerations, including biosafety and biosecurity. The review entity may also include, or have available as consultants, at least one person knowledgeable in the institution’s commitments, policies, and standard operating procedures;
- On a case by case basis, recuse any member of an IRE who is involved in the research project in question or has a direct financial interest, except to provide specific information requested by the review entity; and
- Engage in an ongoing dialogue with the PI of the research in question when conducting a risk assessment and developing a risk mitigation plan.