Investigator-initiated studies often incorporate drugs, devices, and procedures that physician-investigators use in routine clinical practice. While clinical care itself is not subject to oversight by the FDA, OHRP, or IRBs, research involving those same interventions is. For IRBs and research administrators, determining what is conducted because of the research versus regardless of the research is central to regulatory applicability, risk assessment, and ethical review.
Grounded in federal regulations and core ethical principles, this webinar will explore how precise characterization of study activities influences IRB determinations related to regulatory oversight, informed consent, risk–benefit analysis, and participant payment. The session will provide practical strategies for drafting protocols and consent documents that clearly distinguish clinical care from research interventions, engaging IRBs and regulatory stakeholders early in study development, and supporting consistent, defensible review of pragmatic clinical trials across institutional systems.
1 CIP Credit
Cost
Members: FreeNonmembers: $175