Basic Track (SBER)

2019 SBER Conference

Basic

B05 - Exempt or Not? Don't Get Psyched Out By the Benign Behavioral Intervention Research Exemption

Speaker(s)

• 

  Sandra H. Berry

  Chair, Human Subjects Protection Committee, RAND Corporation
  
• 

  Nancy A. Olson, JD
  

  Consultant, Consultant
  
• 

  Michele Russell-Einhorn, JD
  

  Chief Compliance Officer and Institutional Official, Advarra
  
• 

  Ivor A. Pritchard, PhD
  

  Senior Advisor to the Director, OHRP
  

This session will review the draft guidance issued by OHRP on the exemption at 104(d)(3) concerning benign behavioral intervention research. It 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. During this session, speakers and attendees will:

Learning Objectives:

• Understand the key terms that define the scope of the exemption
• Explore what is meant by "prospective agreement" in the exemption
• Use case studies to further explore concepts