Cede Review Resources
BU CTSI Executive Advisory Board Question – Single IRB
How are you addressing the challenges of using SMART-IRB for multicenter trials, regarding preparing teams to use other IRB, or, preparing the BMC/BU Medical Campus IRB to be the IRB of record for external investigators?
IRB Staff:
IRB reliance specialist Roz Schomer is the contact for all questions regarding reliance agreements, whether the arrangement involves BMC/BUMC IRB acting as the IRB of record, or ceding to an external IRB.
Roz Schomer, IRB Reliance Specialist
roz@bu.edu – (617) 358-5329
IRB Website:
Ceding Review: The IRB website contains detailed instructions for preparing the IRB application for ceding review.
Adding External Investigators: The IRB website contains instructions for adding external investigators to a study in which the BMC/BUMC IRB is the IRB of record.
Our electronic IRB application within the INSPIR system is a “smart” form that guides investigators through the submission process for studies seeking to cede review to an external IRB, or studies seeking to propose that the BMC/BUMC IRB act as the IRB of record for external sites.
For multi-site research where the BMC/BUMC IRB as the IRB of record for external site(s), our IRB application collects the following information reflected in our HRPP Policies and Procedures here:
For studies seeking to cede review to an external IRB, we have a Review Path dedicated to cede studies only, which is generated by selecting the following option in the application:
“BMC/BU Medical Campus (the Relying Institution) cedes IRB review to another institution (the Reviewing Institution) under an Authorization Agreement.”
The information that is collected in this cede application is reflected in our HRPP Policies and Procedures here:
7.2.2.18 Requirements for Relying on another IRB
BU CR TIMES:
I Have Ceded Review: Now What Do I Do? (October 2023)
Preparing Commercial IRB Submissions for Multi-Center Industry-Sponsored Trials Where the Sponsor Holds the IND/IDE (October 2021)
SMART IRB AND YOU (October 2019)
*Note: the above article is an update of two previous CR TIMES articles, When Ceding Review:
Adding BMC or BUMC as a Site through an External IRB, March 2018 Issue; and The Complexities of “Simplification” – Using a Single IRB to Review for Multiple Sites, October 2017 Issue.
What’s New with Ceded Studies (October 2018)
*Also, the Things to Know section of the BU CR TIMES newsletter is used to communicate changes/updates to HRPP Policies and Procedures that affect cede review/single IRB.
CRRO Seminar:
I Have Ceded Review – Now What to Do? (10/11/2023)
Cede Review and You — How to Navigate this Evolving “New World” of IRB Review (9/2020):
Ceding Review and SMART IRB (1/2019):
When a Single IRB Reviews for Multiple Sites: The Complexities of “Simplification” (10/2017):
RPN Workshop:
Multi-Site Studies and Single IRB Review (10/23/2023):
Cede Review: Navigating the World of Single IRB (1/2022):
What You Need To Know About Single IRB (10/2018):