B09 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption

Tuesday, November 16, 2021

1:15 PM – 2:15 PM ET

Location: On-Demand

Using case studies, this session will review the draft guidance issued by OHRP on the exemption at 104(d)(3) concerning benign behavioral intervention research. The session will review what kind of studies fall within the scope of the exemption, and what counts as prospective agreement, including prospective agreement and deception research. Session Note: This session was presented at AER20. We’re offering on-demand access during SBER21 for additional access to SBER-related content.

Learning Objectives:

Describe the key terms that define the scope of the exemption
Consider what is meant by "prospective agreement" in the exemption
Identify areas of discord between HRPP professionals and SBER researchers as to what constitutes a benign behavioral intervention
Share conceptual framework/tools for better developing and implementing guidance on what constitutes benign behavioral interventions

Presenter(s)

John D. Horigan, MA, CIP

National Institutes of Health
Rockville, MD
Elicia Preslan, MS, CIP

Virginia Commonwealth University
Richmond, VA
Michelle C. Stickler, DEd, CIP

The University of Texas at Austin
Austin, Texas