Your Guide to sIRB Mandates
Single IRB (sIRB) oversight for multisite research has become a regular practice over the last few years. While sIRB mandates have been on the scene for a while now, it’s still not always clear how a site must comply:
- What do you do if a study involves overlapping sIRB requirements for two different agencies?
- What isn’t addressed in OHRP’s draft sIRB guidance?
- How do exceptions to an sIRB mandate work?
Gain insights into these questions and more from someone who helped put the revised Common Rule mandate in place (Lauren Hartsmith, Director of Regulatory Affairs at Advarra) and someone charged with implementing that sIRB mandate at an academic institution (Kindra Cooper, IRB Director at Creighton University).
Lauren and Kindra discuss what the regulations require, what is and isn’t covered by sIRB mandates, and questions the research community still has about these policies.
Following this free webinar, attendees will be able to:
- Describe key features of federal sIRB mandates (OHRP, NIH)
- Explain how to navigate situations where more than one mandate applies
- Discuss key issues about sIRB utilization not yet addressed by federal agencies
Lauren AJ Hartsmith
Director, Regulatory Affairs
JD, MPA, MA, CIP
IRB Director, Creighton University
Who should watch?
Research professionals from research institutions, academic medical centers, hospital systems, and other sites with local IRBs, IRB professionals, research professionals planning and conducting multisite clinical trials supported by NIH or a Common Rule agency, and others involved in IRB activities for multisite clinical trials.
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.
This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility requirements.
Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching 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 complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour