Conducting Planned Emergency Research in the Era of sIRB

image iconDuration: 1 hour

Planned emergency research (subject to the 21 CFR 50.24 regulations) is challenging for IRBs to review under any circumstance. Now, in the era of single IRB (sIRB), add in the complexity of serving as the designated sIRB reviewing 50.24 research for other institutions in dispersed geographic locations with uniquely different communities.

  • How does the IRB of record ensure the plans for community consultation and public disclosure are adequate?
  • After a plan is approved, how does the IRB ensure the plan is properly executed and the results are acceptable?
  • And how does the relying institution ensure that its local context is considered as part of the community consultation?

In this webinar, we will explore the basics of conducting a 50.24 review from the perspectives of both the reviewing IRB and the relying institution, presenting different perspectives on how best to prepare for conducting planned emergency research in the era of sIRB.

Learning Objectives

Following this free webinar, attendees will be able to:
  • Describe the basic regulatory requirements associated with IRB review of planned emergency research.
  • Recognize the challenges of reviewing and overseeing planned emergency research as the designated sIRB.
  • Outline practical tips for institutions to implement in preparation to conduct or review planned emergency research.

Presented By
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Judith Carrithers

Director of Regulatory Affairs

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Michael Linke

Chair, University of Cincinnati IRB
Chair, StrokeNet Central IRB

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Kelley A. O’Donoghue

Associate VP for Human Subject Protection
University of Rochester

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James Riddle

VP, Institutional Services

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