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.
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 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 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.).
When should I submit a Ceded Review/Reliance Request?
A Ceded Review/Reliance Request can be submitted at any time. However, acknowledgement of the reliance will be held until the initial protocol or amendment to include USC is approved by the reviewing IRB. The investigator cannot conduct study activities until the Reliance Agreement or IAA is fully executed.
Once submitted, how is the Ceded Review/Reliance Requests 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, and obtain a determination from the other sIRB as to whether the request can be accepted. Both IRBs must agree upon the terms of reliance. Once a determination is made by both IRBs, the request will be acknowledged, and any necessary reliance documentation or Reliance Authorization will be executed by both IRBs.
I am a USC PI of a site that will rely upon another IRB for review. What will I need to do?
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 USC 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 reliance agreement made between USC and the external site for a complete list of responsibilities.
Exempt and Expedited Studies: Do I need to complete a submission to USC IRB if the reviewing IRB (sIRB) determines the study meets the exempt or expedited review categories?
Yes. Please follow the instructions below for more information on how to submit a ceded IRB application and its purpose.<
Initial Study Submission: Do I need to submit an iStar application at USC if we rely on another IRB for review?
- Yes. USC will require an iStar IRB Application. At item #1.1 select “Rely on another IRB (Ceded)”.The USC IRB will review the application and check for the following:
- Required local context language
- Required ancillary review(s)
No research activities may take place at USC until you have received an acknowledgement letter from the USC IRB and approval from the sIRB to being.
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.
Consent forms: If study review is ceded to another IRB, do I still use a USC consent form?
The informed consent forms (ICF) to be used at USC will be reviewed and approved by the reviewing IRB. However, the USC ICF will include necessary USC-specific information (CA Experimental Bill of Rights, HIPAA/privacy language, injury language, contact information, etc.). All USC consent forms will be initially reviewed at the time of the ceded submission in order to ensure all local context requirements have been met.
Documents: If study review is ceded to another IRB, what documents do I need to provide the USC IRB?
The USC PI should provide the USC IRB with the following documents:
- The reviewing IRB approval letter
- The reviewing IRB approved protocol
- The reviewing IRB approved consent forms (if there is one)
- The reviewing IRB Authorization Agreement (IAA) for USC to sign (if necessary)
- Any other documents requested
Who would be the IRB Designee to sign an agreement form?
The IRB Director: RoseAnn Fleming, firstname.lastname@example.org
For additional information please contact University of Southern California IRB at: