The USC IRB will agree to rely on an external IRB for IRB review for non-exempt multi-site research. Relying on an external IRB is also called ceding IRB review. Ceding review is the act of transferring IRB review and oversight from the USC IRB to an external IRB. The external IRB becomes the IRB of record (sIRB) that will review research on behalf of one or more institutions.
- NOTE: If the sIRB has determined the study to be “Exempt,” submit an Exempt Review application to the USC IRB and not a Ceded Review application.
USC CEDED REVIEW PROCESS:
The sIRB should confirm in writing that they are willing to serve as the sIRB. This may be done by email, communication from a sponsor/funder, or via the reliance request on the SMART IRB platform.
The sIRB and/or Overall PI/Lead Study Team should provide the USC PI/Study Team with the following documents:
- The sIRB study approval letter
- The sIRB approved protocol
- The sIRB approved consent template (if applicable)
- Any reliance documents required by the sIRB
You must submit a ceded study application via iStar. In section 1.1, select “Rely on another IRB (Ceded).” You should upload the sIRB approval letter, protocol, consent template, and any reliance documents to the ceded study application in section D1.2. NOTE: If the SMART IRB platform is used for the reliance agreement, a determination letter will be issued when the reliance agreement is executed. You will need to upload the determination letter for the reliance agreement.
If a USC consent is needed, you should create the USC consent by revising the sIRB consent template using tracked changes to add required USC language.
The USC required language is listed on the Informed Consent Form Instructions for Industry Sponsored, Cooperative Group, or External IRB Studies found here.
The USC IRB will review the ceded study application for local context.
The submission of the ceded study application will allow the USC IRB to conduct a local context review to confirm that the researchers are qualified to conduct the study at USC and that the study meets all institutional, local, and state requirements. The USC IRB will also determine whether other ancillary reviews are required at USC before the study is conducted (i.e., Clinical Trials Office, Department of Contracts & Grants, Biosafety Committee, Radiation Safety Committee, Conflict of Interest Review Committee, etc.).
The USC IRB will review, complete, and sign any sIRB reliance documents, as needed, when the ceded study application is reviewed.
NOTE: If LA General Medical Center is a participating site and a letter of indemnification is requested from the reviewing IRB, they should remove the indemnification provision since the Los Angeles County Department of Health Services will not sign the letter.
The USC IRB will issue an acknowledgement letter for the ceded study application when all USC requirements are met, and all required ancillary reviews are completed.
The following applies to funded interventional studies:
Participants may not be enrolled into the study until the USC Clinical Trials Office (CTO) or Department of Contracts & Grants (DCG) has provided final cost, payment, and/or injury language for the USC consent form. The USC consent form must be revised to be consistent with the final language, if needed, and reviewed by the USC IRB. The revised USC consent form must then be submitted to the sIRB of record for approval.
NOTE: The investigator cannot conduct study activities until the reliance agreement is fully executed, USC IRB has issued an acknowledgement letter for the ceded study application, and the contract is fully executed.
After the USC IRB issues the acknowledgement letter, you should send the sIRB/Overall PI/Lead Study Team the USC acknowledgement letter, USC consent, and any reliance documents required by the sIRB.
If you are a USC PI who will rely on a sIRB for IRB review, you will need to consider the following:
The USC PI/Study Team is responsible for ensuring that:
- all USC requirements are met
- all required ancillary committee reviews are completed before and while conducting the study at USC
- communicating to the USC IRB any changes that require USC IRB review or review by USC ancillary committees
The USC PI/Study Team is also responsible for:
- communicating with the Overall PI/Lead Study Team
- reporting any local changes to the study team or funding
- providing information for continuing review
- reporting adverse events, participant complaints, unanticipated problems, and noncompliance
- providing access to study records for audit by the USC IRB, sIRB, or other regulatory or monitoring entities
For more information, see Responsibilities of Relying Site Teams -090816-2
If the sIRB approves an amendment, do I need to submit an amendment to the USC IRB?
The USC IRB does not need to review all amendment changes approved by the sIRB. You are required to submit an amendment to the USC IRB for the following reasons:
- Addition or removal of investigators
- New conflict of interest for investigators
- Addition of special populations (e.g., adults who are not competent to consent or minors)
- Addition of LA General Medical Center as a study location
- Changes in HIPAA authorization forms or waivers
- Changes in funding, financial obligation and compensation to participants, or addition of research procedures that require review by other USC committees (i.e., Clinical Trials Office, Department of Contracts & Grants, Biosafety Committee, Radiation Safety Committee, etc.).
Do I need to submit a continuing review to the USC IRB when it relies on a sIRB?
A continuing review does not need to be submitted to the USC IRB. The continuing review will be submitted to the sIRB by the Overall PI/Lead Study Team. You are responsible for providing all necessary information to the Overall PI/Lead Study Team for the sIRB continuing review. No expiration date will be set in iStar for the ceded study application since USC’s reliance on the sIRB will only expire when the study is closed.
NOTE: If the study is closed by the sIRB, the study should be closed in iStar.
If 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 Overall PI/Lead Study Team or sIRB according to the sIRB Standard Operating Procedure for reporting.
If any participant complaints, noncompliance, or unanticipated problems occur at USC, you must also report them to the USC IRB. Submit the reportable event in iStar as soon as possible, but no later than 10 working days after you become aware of the event.
NOTE: Failure to report an event may result in the suspension of the study, and reporting to the required agencies, including funding agency, regulatory agencies (i.e., FDA, OHRP), etc.
For additional information please contact the USC IRB at reliance@usc.edu.
