D07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and Members

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Incidents of noncompliance may occur in human subjects research. At many organizations, the IRB serves an important role in assessing these events and determining if any corrective actions proposed are appropriate. However, little guidance exists to help IRB members and chairs navigate these reviews and understand how to assess these events and any planned follow-up. This interactive session is designed to discuss the role of IRB members and chairs in reviewing incidents of noncompliance and making assessments of whether events may qualify as serious and/or continuing noncompliance. IRB members and chairs, and HRPP/IRB professionals that support IRB members in their reviews are encouraged to attend to share their experiences and strategies. Through interactive discussion of case examples highlighting real-world incidents of noncompliance, this session seeks to build skills in reviewing incidents of noncompliance, in reviewing (and assisting investigators in constructing) corrective action plans, in making determinations of serious and/or continuing noncompliance, and in considering whether participant notification of errors is appropriate. Attendees will also consider issues related to review of events occurring at other sites when the IRB is serving as the single IRB of record (sIRB) for multisite research.