F06 - Human Subjects Research Determinations: Before and After the Fact

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HRPPs are often contacted with requests for HRPP/IRB approval of a project that has already occurred. More often than not, these endeavors constitute a QA/QI undertaking or a project that fails the regulatory definition of research at its onset, with research "interest" occurring later (often when submitting findings for publication). Institutions may feel a lack of empowerment to interpret components of the regulatory definition of research where the regulations are silent (e.g., terms such as "research development" or "generalizable knowledge"). HRPPs must clearly communicate institutional policies and procedures for human subjects research determinations and local interpretation of regulatory requirements. This session will provide attendees with examples of different institutional interpretation of regulations and review pathways and helpful tips for how institutions and HRPPs can address requests for approval after a project is complete.