A PRIM&R Webinar
Regardless of the Research: Regulatory Strategy and IRB Approval of Pragmatic Clinical Trials
March 31, 2026 1:00 – 2:00 PM ET
Overview
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.
What Will You Learn?
- Explain the regulatory foundation for COI oversight in human subjects research, including PHS/NIH FCOI regulations, FDA financial disclosure requirements, and OHRP expectations for institutional conflict policies
- Differentiate between investigator, IRB member, and institutional-level conflicts, and analyze how each is addressed under the applicable regulations and HRPP responsibilities
- Assess strategies for HRPP-COI Office coordination, including integrated disclosure workflows, shared review triggers, and communication pathways that support compliant and holistic conflict management
You Will Learn How To:
Apply federal regulatory requirements and ethical principles to distinguish routine clinical care from research activities in pragmatic clinical trial protocols.
Evaluate and communicate research risks appropriately in informed consent when clinical care and research procedures intersect.
Assess participant payment structures for pragmatic clinical trials using ethical and regulatory frameworks relevant to IRB review and institutional oversight.
Presenters
- Kelly Fitzgerald IRB Executive Chair and Vice President of IBC Affairs, WCG Clinical
- Lauren Milner Policy Advisor and Bioethicist
CIP® Credit
Participants holding the Certified IRB Professional (CIP®️) credential may apply 1 continuing education credit towards CIP recertification. Please refer to the CIP recertification guidelines for additional information.
CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this workshop. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R workshop may be used.
Accommodations
PRIM&R is committed to hosting inclusive, accessible events that enable all individuals to engage and participate fully. For inquiries about session accessibility or requests for specific accommodations, please contact Scott Rule at srule@primr.org or 617.303.1876. Requests for American Sign Language interpreters and/or CART providers should be made at least two weeks in advance of the event. Please note that PRIM&R will make every effort to secure services, but that these services are subject to availability.
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