I am a USC PI who wants to participate in a multi-site study and cede IRB review to an external Central/Single IRB (sIRB). What do I need to know?
What is Ceded Review?
- Ceding review is the act of transferring IRB review and oversight from the local IRB (USC IRB) to an external IRB. The external IRB becomes the reviewing IRB or IRB of record who will review on behalf of one or more institutions. The reviewing IRB may also be referred to as the single IRB (sIRB) and/or central IRB. The relying institution is the entity that agrees to rely upon the reviewing IRB or sIRB.
- Note: If the IRB of record has determined the study to be “Exempt”, submit an Exempt Review application to the USC IRB and not a Ceded Review application.
How do I submit a request for USC to rely on the sIRB?
Submission of an iStar IRB Application is required. At item #1.1, select “Rely on another IRB (Ceded)”.Even when USC IRB will not review a protocol, it is important that we have record of the research conducted at USC and is under the jurisdiction of another IRB. Although IRB review will be conducted elsewhere, there are other ancillary reviews that may need to occur at USC (radiation safety committee, conflict of interest review committee, etc.).
The Ceded Review submission in iStar is not an IRB approval process (since the IRB review will be ceded to another institution) but rather is a means to acknowledge a request to cede oversight to an external IRB. It will trigger applicable USC ancillary reviews, and track research activities occurring at USC.
What documents are needed for a Ceded Review?
The reviewing IRB approval letter
The reviewing IRB approved protocol
The reviewing IRB approved ICF (if applicable)
The USC ICF (the approved ICF that has been revised to add required USC information)
Any other documents requested by USC IRB
What is a Reliance Agreement?
- A Reliance Agreement (also known as an IRB Authorization Agreement (IAA)) is an agreement between institutions that defines the relationship between the sIRB (reviewing IRB) and relying sites (also known as participating sites). Submission of a Ceded Review in iStar initiates establishment of a Reliance Agreement.
How is a Reliance Agreement request reviewed?
The IRB administrator will review the request, submission, obtain any/all additional information from investigators, and determine whether the request can be accepted on behalf of the USC IRB. Both IRBs must agree upon the terms of reliance. Once a determination is agreed upon by both IRBs, the request will be acknowledged, and any necessary reliance documentation or reliance authorization will be executed by both IRBs.
Who is the IRB Designee to sign an agreement form?
The IRB Director: RoseAnn Fleming, firstname.lastname@example.org
When should I submit a Ceded Review Request?
A Ceded Review/Reliance Request can be submitted at any time. The investigator cannot conduct study activities until the Reliance Agreement or IAA is fully executed and USC IRB has acknowledged the study.
The following applies to funded studies:
Enrollment of participants cannot begin until the USC Department of Clinical Trials Office or Contracts & Grants has provided final cost, payment, and injury language for the USC consent form. When the USC Department of Clinical Trials Office or Contracts & Grants completes their iStar consistency checklist that includes the final cost, payment, and injury language – the USC consent form must be reviewed, and if necessary, revised to be consistent with the final language required. The revised USC consent form must then be submitted to the USC IRB and the IRB of record for approval.
Once submitted, how is the Ceded Review/Request reviewed?
The Ceded Review iStar submission is reviewed by a USC IRB Administrator through an administrative process. The Administrator will review the submission, obtain any/all additional information from investigators, determine whether the request can be accepted on behalf of USC IRB.
If you are a USC PI that will rely on another IRB for review you will need to consider the following:
What responsibilities will the research staff and I have?
The USC PI is responsible for obtaining all regulatory protocol information (approved protocol, approved consent documents, etc.) from the “Overall or Lead PI”. Any questions or required reporting will need to go through the Lead PI at the reviewing IRB site. Once the Ceded Review application is acknowledged and a fully executed agreement has been received by both IRBs, the USC investigator will primarily interact with the reviewing IRB for protocol issues related to the research. The USC investigator will be responsible for providing information needed at the time of continuing review and when reportable events occur. Please refer to the external site for a complete list of responsibilities.
Amendments: If study review is ceded to another IRB, do I need to submit an amendment at USC?
The USC IRB does not need to review all amendment changes. The USC IRB will review amendments for the following reasons:
- Addition or removal of investigators
- New conflict of interest for investigators
- Addition of special populations (adults who are not competent to consent or minors)
- Addition of LAC+USC Medical Center as a study location
- Changes in HIPAA authorization forms or waivers
- Changes in funding or addition of research procedures that require review by other USC committees (Clinical Trials Office, Department of Contracts & Grants, and Radiation Safety Committee)
Continuing Reviews: If study review is ceded to another IRB, do I need to submit a continuing review to USC IRB?
The continuing review that occurs at the “reviewing” site’s IRB will include USC’s involvement in the research. Therefore, you will need to provide all necessary information to the reviewing IRB’s continuing review – the site USC is relying upon. A continuing review at USC will not occur. No expiration date will be set in iStar, as USC’s reliance does not expire.
Unanticipated problems: If study review is ceded to another IRB, and a reportable event has occurred with one of my participants, who do I report it to?
You must report adverse events, unanticipated problems, protocol deviations, participant complaints, and other reportable events to the Central or sIRB that the site USC is relying on, and according to the Standard Operating Procedure for Central Institutional Review Board Reporting. If any reportable even occur at USC, the USC investigator must also report them to the USC IRB, no later than 10 working days after the investigator becomes aware of the event. Failure to report an event may result in the suspension of the study, and reporting to the required agencies, including funding agency, regulatory agencies (FDA, OHRP), etc.
For additional information please contact University of Southern California IRB at: