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Conducting Planned Emergency Research in the Era of sIRB
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.
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.
Director of Regulatory Affairs
Chair, University of Cincinnati IRB
Chair, StrokeNet Central IRB
Kelley A. O’Donoghue
Associate VP for Human Subject Protection
University of Rochester
MCSE, CIP, CPIA, CRQM
VP, Institutional Services
Who Should Watch?
Content applies to IRB Directors, IRB Chairs, and other IRB professionals.
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
After completing this webinar in its entirety, you will receive a certificate of attendance. This certificate will include your full name, and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and take the survey at the end. Visit our Webinar Help page for more information on certificates of attendance.
Duration: 1 hour