D13 - Best Practices for Ancillary Review in a Single IRB World

Thursday, November 18, 2021

1:30 PM – 2:30 PM ET

Location: On-Demand

The NIH and Common Rule require single IRB review for most multi-site research. The primary motivation behind the single IRB requirement was to streamline time to study start up and completion. However, IRB review is only one component of the study activation. If ancillary review, as required by the institution, is not streamlined, any gains from single IRB review are limited. This session will explore the relationship between ancillary reviews and IRB review, especially in a single IRB arrangement, and best practice recommendations for ancillary review proposed by aSMART IRB Harmonization Working Group.

Learning Objectives:

Discuss the challenges ancillary reviews present for IRB approval of participating sites and for study activation at different participating sites
Define ancillary reviews, identify when ancillary reviews should be completed in relation to the single IRB's review and approval of a participating site, and distinguish which ancillary reviews are relevant to study activation at a participating site
Review the roles and responsibilities related to ancillary review in a single IRB arrangement

Presenter(s)

Nichelle Cobb, PhD

AAHRPP
Madison, WI
Ivana Simic, PhD

University of Florida
SS

Suzanne Stone, MA, CIP

University of California, Berkeley, CA