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A PRIM&R Workshop

Exploring the IRB Administrator’s Role in the Life Cycle of a Protocol Review

Thursdays | May 1, 8, and 15 1:00–3:00 PM ET

Register

Overview

This comprehensive workshop provides compliance professionals with an in-depth understanding of the critical roles and responsibilities IRB administrators hold throughout the entire life cycle of a research protocol. From the initial submission of a new research protocol to its final study closeout, this workshop equips participants with the tools and knowledge needed to navigate the complexities of protocol management and regulatory compliance. Delivered in three interactive 2-hour sessions, the workshop is designed for IRB administrators and research compliance professionals. It focuses on the challenges and nuances of managing protocol reviews within highly regulated environments, providing hands-on experience to address key issues that arise in both early-stage and late research. Through practical activities and collaborative discussions, participants will apply core concepts and strategies to real-world scenarios, strengthening their ability to manage research protocols effectively while ensuring compliance with regulatory guidelines and ethical standards. This workshop is ideal for professionals who interact with the IRB process including clinical coordinators, clinical research associates, and monitors or anyone involved in managing and submitting protocols. It offers valuable insights into the regulatory landscape and practical solutions to optimize your workflow, ensuring that protocols are managed effectively and are compliant.

Cost:

Members: $350Nonmembers: $595

Agenda

Session 1: Thursday, May 1, 2025 1:00–3:00 PM ETIntake: What Needs IRB Review?
Session 2: Thursday, May 8, 2025 1:00–3:00 PM ET Initial IRB Review
Session 3: Thursday, May 15, 2025 1:00–3:00 PM ETAfter Initial Review

What Will I Learn?

  • The core responsibilities of an IRB administrator throughout the lifecycle of an IRB submission, from receipt of protocol for review to post-approval monitoring.
  • The IRB submission process, including determining the need for review, initial review procedures, and post-approval activities, while highlighting key terminology and concepts.
  • How to apply ethical principles and regulatory guidelines to real-world scenarios and case studies within the workshop, demonstrating the ability to make informed decisions regarding IRB review and compliance.

Who Should Attend?

IRB administrators with at least one year of experience, or who have attended the PRIM&R Workshop Exploring the Common Rule: A Guide for Beginners.

CE Credit

Participants will receive a certificate of attendance that documents up to 6 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. This program is under review by the CIP/CPIA Council for recertification by continuing education credit hours.

Contributors

Nichelle Cobb, PhD, CIP

Senior Advisor for Strategic Initiatives Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Nichelle Cobb, PhD, is the Senior Advisor for Strategic Initiatives for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and was previously a site visitor for AAHRPP and member of AAHRPP’s Council on Accreditation. Prior to joining AAHRPP, she served as the Human Subjects Protection Officer for the Institute for Clinical & Translational Research at the University of Wisconsin-Madison and was the Director of the Health Sciences Institutional Review Boards (IRBs) for 16 years. Nichelle has been involved in single IRB work for more than a decade and currently serves as a Senior Advisor for SMART IRB, a federally funded project that supports the implementation of single IRB. In addition, Nichelle is a member of the SMART IRB Harmonization Steering Committee and has co-led working groups to harmonize IRB and Human Research Protection Program (HRPP) practices, such as reportable events, ancillary reviews, local context, and continuing review. Nichelle served on this year's human subjects research planning committee for PRIM&R Annual Conference and co-teaches courses for PRIM&R, including Exploring the Common Rule and IRB Administrator Core Training. She has written articles on the IRB process, single IRB, and eConsent.

Nancy Olson, JD

IRB Analyst University of Nebraska Medical Center
Nancy A. Olson, JD, is an IRB Analyst at the University of Nebraska Medical Center. She has more than 20 years of experience working with Institutional Review Boards, including as the former Director of the Human Research Office at the University of Mississippi Medical Center, and consulting in the field of human research protections. Nancy serves as a faculty member for PRIM&R's IRB Administrator and At Your Doorstep programs, and as a speaker at regional and national meetings, including PRIM&R and AAHRPP. She also contributed to the Third Edition of Institutional Review Board Management and Function. Nancy was a member of the SACHRP Subpart A Subcommittee, a consultant to the Office for Human Research Protections, a past Co-Chair of PRIM&R's Advancing Ethical Research Conference Poster Abstract Sub-Committee, a PRIM&R Board Member, and ARENA president.