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Reefer Sanity: IRB Review That Won’t Vaporize Cannabis Protocols
With more widespread use of cannabis, how can data from well-designed clinical research trials better characterize its safety and efficacy as a medicine?
Cannabis’ complicated legal history, ongoing safety concerns, and unique study design elements can present challenges for institutional review boards (IRBs) reviewing these trials. Despite this, IRBs can also play a role in improving the quality of cannabis research
Join this webinar for guidance on developing and reviewing cannabis studies – with the goal of protecting human subjects while allowing this important research field to progress.
Learning Objectives
Following this webinar, attendees will be able to:
- Describe essential elements of study design needed to generate reliable, reproducible, and generalizable data
- Identify elements of safety monitoring needed to protect research subjects and cannabis users in general, including assessment of addiction potential
- Apply regulatory criteria to determine review pathway (expedited or full convened board) and approvability
Presented By
Lizbeth Adams
PhD, CIP
Former Executive Vice Chair, IRB Advarra
Advarra
Amanda Higley
PhD
IRB Chair
Advarra
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Duration: 1 hour