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TIN webinar: SMART IRB Agreement 3.0 Proposed Revisions

Barbara Bierer, MD,  Nichelle Cobb, PhD  &  Polly Goodman, CIP

The SMART IRB Agreement was launched in 2016 after extensive collaboration with government agencies, academic medical centers (including all Clinical and Translational Science hubs and many of their affiliates), and industry partners. To date, the SMART IRB Agreement has been signed by over 1130 entities, supported by (1) the SMART IRB platform, a robust online reliance system to support reliance requests; (2) numerous resources to train and educate the regulatory and investigator community, including a publicly-available learning center; and (3) a highly functional harmonization steering committee facilitating the alignment of policies and processes related to single IRB review.

Over the past few years, SMART IRB leadership and representatives from the National Institutes of Health (NIH), Department of Defense (DOD), Department of Veterans Affairs (VA), and Department of Energy (DOE), have engaged in discussions regarding revisions to the Agreement to enable these federal agencies and other institutions to sign on to the SMART IRB Agreement. The proposed revisions reflected in SMART IRB Agreement version 3.0 are provided for review and comment to all current and prospective signatory institutions.

This webinar will provide:
• A summary of the proposed changes
• How public comments are submitted
• An overview of the process, timeline, and requirements for signing and re-signing the SMART IRB Agreement version 3.0
• New and existing SMART IRB resources and educational tools