Hot Topics Track (SBER)

2019 SBER Conference

11/13/2019 6:00 PM

C05 - Benign Behavioral Interventions (BBI) in Practice

Speaker(s)

• 

  Alma Castro, MA, CIP
  

  Sr. IRB Review Specialist, Harvard T.H. Chan School of Public Health
  PhD Candidate, University of Massachusetts Amherst
• 

  Matt D. Stafford, MPH
  

  Assistant Director, Clinical Research Compliance, Boston Children's Hospital
  Co-Chair, Regulatory Working Group and SBER Subcommittee, Harvard Catalyst
• 

  Ivor A. Pritchard, PhD
  

  Senior Advisor to the Director, OHRP
  

This session will focus on how IRBs are defining BBI in Exempt Category 3 and how IRBs are making the determination of whether an intervention meets the Exempt category 3 criteria or not. Sample cases of BBIs in SBER and mixed SBER/biomedical research will be explored. Additionally, IRB decision-making processes for each case will be discussed with the goal of promoting IRB best-practices. Before attending this session, attendees should have working knowledge of the revised Common Rule, its exemption categories, and familiarity with SBER disciplines. During this session, speakers and attendees will:

Learning Objectives:

• Review the definition of BBIs per federal regulations, OHRP, and SACHRP guidance
• Explore real-life examples of SBER involving BBIs that IRBs reviewed, as well as the resulting determination of whether the intervention did or did not meet the BBI definition in Exempt category 3
• Discuss IRB best practices when determining whether research involving BBI in SBER and mixed SBER/biomedical research meets the federal regulatory definition in Exempt category 3