Webinar: Navigating the New Reliance Agreement Landscape

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Overview

The Notice of Proposed Rulemaking (NPRM) and the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research foreshadow a shift to a regulatory and funding landscape requiring single IRB review of multi-site research. Institutions have already begun adapting by entering into IRB reliance agreements with other institutions, serving themselves as a relying institution, or becoming the IRB of record. Increasingly complex multi-site arrangements or “master” agreements—involving more than two institutions, multiple protocols, or institutions serving alternately in both relying and reviewing roles—are becoming more common. How can institutions and IRBs prevent problems and address the challenges that may arise from reliance arrangements?

During this intermediate-level webinar, an IRB director and a research attorney reviewed the current NIH funding environment, and the NPRM and NIH policy behind these developments. The speakers identified and provided strategies for navigating common areas of uncertainty and for addressing key implementation challenges, including:

  • Maintaining transparent communication pathways and exchange of information among relying institutions and their IRBs, investigators, and the IRB of record
  • Defining the relying institution’s reporting obligations to the IRB of record and vice versa
  • Identifying responsibilities with respect to externally reportable events
  • Engaging and educating investigators and research teams on their role in the reliance arrangement

Commentary was provided from the perspective of the relying institution as well as the IRB of record, and was relevant to reliance arrangements with fellow research institutions as well as with independent IRBs

Learning Objectives

After attending this webinar, attendees were able to:

  • Understand the current landscape and future challenges surrounding reliance arrangements
  • Address common challenges related to implementing and maintaining compliant reliance relationships

Who should attend?

This intermediate-level webinar is of value to IRB staff and members, as well as researchers and research teams, who work with reliance agreements on a regular basis, serving either as the IRB of record, the relying institution, or both.

Faculty

Emily Chi FoglerEmily Chi Fogler, Esq., is counsel in the Academic and Clinical Research Group within the Health Care Group at Verrill Dana LLP. Her practice focuses on a range of issues and areas related to the conduct and oversight of clinical research, including human subject protection; HIPAA privacy; other regulatory compliance; single, central, and other cooperative IRB review arrangements; sponsored research and other collaborative research agreements; human tissue and data repositories; data-sharing agreements; and clinical quality measurement and research contracts. Prior to joining Verrill Dana, Emily served for more than a decade as senior legal counsel in the Research &Technology section of the Office of General Counsel at Partners HealthCare in Boston, MA, which includes Massachusetts General Hospital and Brigham and Women’s Hospital. Before working with Partners, she was an associate at Ropes & Gray LLP, and a law clerk to the Honorable Patti B. Saris of the U.S. District Court for the District of Massachusetts. Ms. Fogler is a graduate of Harvard Law School, where she was an executive editor of the Harvard Law Review.

Tracy ZiolekTracy Ziolek, MS, CIP, is the executive director for human research protections at the University of Pennsylvania. She also directs the University of Pennsylvania IRB, which consists of 9 IRBs. She serves as the regulatory representative on several of the IRBs, including those that review biomedical and social and behavioral research. She is also the delegate for the Institutional Official for the execution of Institutional Authorization Agreements (IAAs) or Individual Investigator Agreements (IIAs). She is responsible for developing and implementing policy as is relates to research with human subjects and advises the Institutional Official on matters related to human subject protections. Tracy has her Master's Degree in Biomedical Writing and is a Certified IRB Professional. She has been with the Penn IRB since 2004.

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Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext. 0.

CE Credit for Certified IRB Professional (CIP®) Recertification

Webinar participants holding the CIP®credential who wish to apply credits from this webinar toward CIP®recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Contact Information

If you have additional questions about webinar archives, please contact us by phone (617.423.4112, ext. 1876) or via email.