Reefer Sanity: IRB Review That Won’t Vaporize Cannabis Protocols

image iconDuration: 1 hour

Cannabis and cannabis-derived products are being used with increasing frequency in both recreational and therapeutic settings. With more widespread use of cannabis, how can data from well-designed clinical research trials better characterize its safety and efficacy as a medicine?

For IRBs charged with reviewing these protocols, the complicated legal history of cannabis and ongoing concerns about its safety can present challenges. Furthermore, aspects of study design pertaining uniquely to botanical medicines—dose standardization, for example—can be difficult for IRBs to evaluate. Despite these challenges, IRBs can help improve the quality of cannabis research by requiring sound study design and adequate safety monitoring.

In this webinar, Advarra IRB experts provide guidance for developing and reviewing cannabis studies with the goal of protecting human subjects while allowing this important field of research to progress. 

Learning Objectives

Following this free 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_orange.png

Lizbeth Adams

Executive Vice Chair, IRB

Amanda Higley_orange.png

Amanda Higley

IRB Chair

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