Conducting Planned Emergency Research in the Era of sIRB

Planned emergency research (subject to the 21 CFR 50.24 regulations) is challenging for institutional review boards (IRBs) to review under any circumstance.

Now, the era of single IRB (sIRB) adds the complexity of a designated sIRB reviewing for other institutions in dispersed geographic locations with uniquely different communities.

In this webinar, explore the perspectives of a reviewing IRB and a relying institution, presenting different angles on how best to prepare for conducting planned emergency research in the era of sIRB.

Learning Objectives

Following this 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, including how to:

Ensure plans for community consultation and public disclosure are adequate
Ensure the plan is properly executed and results are acceptable
Incorporate local context in reviewing community consultation plans

Outline practical tips for institutions to implement in preparation to conduct or review planned emergency research

Presented By

Judith Carrithers

JD, MPA

Former Director of Regulatory Affairs
Advarra

Michael Linke

PhD, CIP

Chair, University of Cincinnati IRB
Chair, StrokeNet Central IRB

Kelley A. O’Donoghue

MPH, CIP

Associate VP for Human Subject Protection
University of Rochester

James Riddle

MCSE, CIP, CPIA, CRQM

VP, Institutional Services
Advarra

Who Should Watch?

Content applies to IRB Directors, IRB Chairs, and other IRB professionals.

CEU Credits

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.