SBER Network Discussion: Postapproval Monitoring for SBER—Alternatives to Continuing Review for Minimal Risk Research

Wednesday, November 17, 2021

3:00 PM – 4:00 PM ET

Location: Livestreamed

Join the SBER Network in discussing postapproval monitoring for SBER. The 2018 Common Rule sought to strengthen participant protections while reducing administrative burdens. One of the burden reducing provisions includes removal of the requirement of continuing review for minimal risk research (unless FDA-regulated). IRBs are responsible for oversight of active human research and historically, continuing reviews were a mechanism for monitoring research. This SBER Network session will offer diverse perspectives on these issues. What are institutions doing now to monitor active studies after initial IRB approval? Has the continuing review process changed (and how)? How are monitoring efforts working and what are the challenges? Has administrative burden been reduced and have monitoring efforts been more effective?

Learning Objectives:

Review different forms of PAM and how they are working
Discuss procedures for determining when studies undergoing continuing review or a PAM alternative
Share experiences with educating PIs and research personnel about the changes to the new system

Moderator(s)

Cecilia Brooke Cholka, PhD, CIP (she/her/hers)

Weill Cornell Medicine

Speaker(s)

John R. Baumann, PhD

Indiana University
Indiana University
Indianapolis, IN
Erin M. Odor, MA, CIP

The Ohio State University
Columbus, OH
Linda E. Mayo, BA, CIP

The University of New Mexico
Albuquerque, NM
Sharon Zack, MS

Westat
Rockville, MD