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Discussion of how to assure the rights and welfare of human subjects in research at each entity involved in the research usually begins with an evaluation of whether or not each entity is “engaged” in human subjects research (refer to the section on Cooperative Research). If a determination is made that the outside institution is engaged in human subjects research and the outside institution is receiving federal funds through a subcontract with the UI, the UI Division of Sponsored Programs requires documentation that the outside institution holds an FWA through the subcontract process. If the outside institution does not hold its own FWA, the UI requires that they obtain one prior to finalization of the subcontract.
If this is the case, and the other institution obtains its own FWA, there are a few methods of IRB oversight that the UI IRB would consider acceptable based on the circumstances of the project and the role of the other institution. The UI IRB may accept the other institution’s IRB as the IRB of record for the project. This would be in cases where the UI determines that the outside institution’s IRB review will provide more appropriate expertise, oversight, and/or knowledge of local context for the UI role in the study. This agreement is formalized using an IRB Authorization Agreement or other equivalent agreement. The outside IRB is then added to the UI FWA. Research projects utilizing the VAMC are not eligible to receive this type of deferred judgment.