C03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA Edition

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The introduction of the various sIRB mandates (e.g., NIH, Common Rule, and potentially FDA) has created new complexities for what were once routine research administrative activities, such as PAM. As institutions continue to navigate PAM for studies subject to the various sIRB mandates, a new mandate from the FDA would further complicate this function for studies not currently subject to sIRB mandates. Some such variables, which would impact this critical function in the protection of human subjects, that may be unique to the FDA mandate include monitoring for industry-funded studies vs. small minimally- or unfunded investigator-initiated trials, differences in monitoring between funded and unfunded research, monitoring investigator-held Investigational New Drugs and Investigational Device Exemptions across multiple institutions, monitoring studies subject to the exception from informed consent provisions and community consultation/public disclosure.