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2022 PRIM&R Annual Conference

Social, Behavioral, and Educational Research

A04 - Categorical Conundrum: What Is the Tipping Point for Non-Exempt SBER Needing Convened Review

Monday, December 12, 2022
11:45 AM – 12:45 PM ET
Location: Livestreamed
Livestreaming Session Icon CIP Accredited Human Subjects Research Deep Dive Series
What is the tipping point for a behavioral study to move from expedited review to full board review outside of simply not meeting an expedited category, which is rare in behavioral research? When does the idea of what is minimal risk come into question such that a group of people would need to discuss it at a meeting? SBER usually meets the exempt and expedited categories, thus not qualifying as greater than minimal risk. This session will explore when SBER crosses the threshold for a full board discussion and what factors may contribute to that decision.

Learning Objectives:

  • Explore whether there are times when a minimal risk social behavioral study technically meets the requirements for an expedited category, but would be more appropriate for a convened board discussion
  • Examine how topics such as suicide, illegal and illicit drugs, criminal activity, immigration status, etc., are handled regarding full board or expedited review, and whether a Certificate of Confidentiality plays a role in the decision
  • Consider the extent to which certain populations influence the decision to bring a study for full board consideration