A PRIM&R Workshop
Maintaining Compliance at Any Size: How to Get the Most Bang for Your Buck!
February 24, 2026 1:00 – 2:30 PM ET
Overview
Not all HRPP programs have equal resources or the same compliance needs, yet every HRPP—regardless of size—must have compliance and monitoring processes in place to help ensure adherence to the Common Rule (45 CFR 46), FDA human subjects regulations (21 CFR Parts 50 and 56), and the ethical principles that guide research oversight. Programs must structure their processes so they fulfill required regulatory functions such as review, continuing oversight, reporting, and documentation, while maintaining flexibility to adapt to institutional constraints and changing operational environments.
In this session, speakers will discuss how their QA/QI program structures and models. They will highlight approaches to meeting mandated compliance activities while managing program size, staff capacity, and institutional priorities.
What Will You Learn?
Describe strategies for designing flexible compliance initiatives that ensure adherence to 45 CFR 46 and 21 CFR Parts 50/56 while accounting for an organization’s research portfolio, investigator experience, and QA/QI capacity.
Provide practical strategies and tools that may be adapted according to an organizations needs while still maintaining ongoing regulatory compliance in settings with limited or fluctuating resources.
Speakers
- Alyssa Speier, MS, CIP Senior Associate Director of Regulatory Affairs, Research Compliance & Education, Harvard T.H. Chan School of Public Health.
- Courtney Karmelita, D.Ed Chief of Staff for Penn State’s Office for Research Protections, Research Integrity Officer, and Executive Director of Ethical Research and Outreach, Penn State University
- Neala J. Lane, MA, CCRC, Associate Director HRPP/Quality Improvement, Indiana University.
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.
CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. 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 webinar may be used.
Access Interval
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.
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