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Call for Session Proposal - CSP
Call for Session Proposal - CSP
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2024 PRIM&R Annual Conference

Social, Behavioral, and Educational Research

IRB Review

B09 - When SBER Meets the Definition of a Clinical Trial, Then What?

Monday, November 18, 2024
1:45 PM - 3:00 PM PT
Location: Room 347-348
Live Session Recorded Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP CIP Accredited
CLICK HERE to view captioning for this session! 

Some social-behavioral controlled trials may meet the NIH definition of a clinical trial. For example, the use of a mobile app to provide a mindfulness intervention and measure the change in behavior over time in relation to stress reduction. This session will cover when SBER crosses over into the clinical research space.

Learning Objectives:

  • Learn the definition of a clinical trial in relation to SBER
  • Identify what additional information needs to be considered by the IRB, for example, FDA regulations and/or ClinicalTrials.gov registration
  • Understand how funding plays into decisions and how it can possibly change the review paths