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? (Presented on July 12, 2016)
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
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.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
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