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A PRIM&R Workshop

Exploring the Common Rule: A Guide for Beginners

Purchase Recording

New to IRB Administration?

Does the Common Rule seem daunting? If so, this workshop is for you! Gain a comprehensive understanding of the regulations that guide human protections. This workshop provides a foundation to efficiently review research, effectively communicate with researchers, and ensure that research conducted at your institution is in compliance.
Offered in three 2-hour sessions, this workshop will provide you with a road map to navigate sections of the Common Rule and set you on the path to a successful career in IRB Administration.

Cost:

Members: $350Nonmembers: $595

Agenda

Session 1: Getting There: Discovering the Common Rule What is the Common Rule, where can you find it, and how do you read it? Session 2: The Main Attraction: Regulations Related to the Review Process Understand key sections of the Common Rule that relate to IRB review activities. Session 3: Notable Landmarks: Other Requirements You Need to Know Responsibilities beyond the IRB review process that the Common Rule outlines and that IRB administrators might assume.

What Will I Learn?

  • Where and how to find the essential documents and resources you need to implement the Common Rule.
  • How to interpret key sections of the Common Rule, including IRB functions, operations, and IRB review of research.
  • How to identify responsibilities outside of the IRB review of research often assigned to IRB administrators.

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.

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.