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New Umbrella Protocol Policy for Minimal Risk Record Review Research
In response to investigator feedback, the Office of Research Integrity (ORI) has developed a new Umbrella Protocol Policy for Minimal Risk Record Review Research. This policy establishes a structured pathway for conducting multiple, related record review studies under a single IRB‑approved framework.
The umbrella protocol model promotes efficiency while maintaining appropriate regulatory and ethical oversight. It is designed for minimal risk research involving retrospective or prospective record review that does not include intervention or interaction with human subjects.
Although the Institutional Review Board (IRB) retains final authority to approve umbrella protocols and associated sub‑studies, the policy standardizes researcher processes and supports consistent IRB review practices.
Previously approved umbrella record review protocols may continue to operate as approved. However, researchers are expected to transition to the new policy requirements through a modification request or as part of the Annual Administrative Review.
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