Upstate Medical University

New York State SOCRA Chapter Presents: Navigating the Single IRB Process

In 2018, the National Institutes of Health issued a policy requiring single IRB review for most multisite research, which was followed by a revision to the Common Rule that also required single IRB for cooperative research. Now the Food and Drug Administration is considering changing its rules to make single IRB review the expectation for most multisite research. This session will explore single IRB requirements and their implications for researcher and how study teams can be successful in adapting this new IRB landscape.

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Polly Goodman, CIP
Associate Director, Regulatory Affairs Operations for SMART IRB, Harvard Catalyst
Polly Goodman, CIP serves as the Associate Director of Regulatory Affairs Operations for SMART IRB, an initiative sponsored by the National Center for Advancing Translational Science (NCATS) to create a master IRB authorization agreement and support single IRB review. In this role she offers training and support for IRB staff and investigators on issues related to single IRB review.

Michael Linke, PhD, CIP

SMART IRB Program Director for Education and Training; Chair, University of Cincinnati IRB and StrokeNet Central IRB; Adjunct Professor of Internal Medicine, University of Cincinnati
Mike is currently an Adjunct Professor of Internal Medicine at the UC College of Medicine and has served as chair of the UC IRB since 2004.   He led the formation of the StrokeNet Central IRB in 2014.  The NIH created StrokeNet to conduct clinical trials to advance acute stroke treatment, stroke prevention, and recovery. The StrokeNet Central IRB is currently overseeing 10 StrokeNet studies at over 900 research sites.  As SMART IRB Program Director for Education and Training, he leads the SMART IRB Training and Educational Leadership Team (TELT).  The TELT coordinates and drives the education component of the SMART IRB platform. 

Nichelle Cobb, PhD
Senior Advisor for Strategic Initiatives, Association for the Accreditation of Human Research Protection Programs
Prior to joining AAHRPP, Nichelle was the Director of the Health Sciences Institutional Review Boards (IRBs) for 16 years at the University of Wisconsin-Madison and has worked with IRBs for 20+ years. Nichelle has been involved in single IRB work for more than a decade and was instrumental in the development of the SMART IRB Reliance Agreement and serves as a Senior Advisor and Ambassador for SMART IRB, a federally funded project to support the implementation of single IRB.