I am a USC PI and want to serve as the Lead PI for a multi-site study. What do I need to know?
How do I submit a request for another institution to rely on USC as the Reviewing Site (sIRB) for a multi-site study?
In order to allow another institution to rely on USC IRB for study review and oversight, a protocol must be submitted, under review, or approved in iStar. USC IRB will serve as sIRB for not more than 4 relying sites on a protocol submission. Respond to questions in iStar IRB Application item # 6.2 Study Locations. At item # 6d., add the names of the relying sites/institutions. A Reliance Agreement (also known as an IRB Authorization Agreement (IAA)) will be established between USC and each relying site.
What is a Reliance Agreement?
A Reliance Agreement, or IAA, is an agreement that defines the relationship and responsibilities of USC, the sIRB (reviewing IRB), and the relying sites (also known as participating sites).
When should I submit a request?
A reliance request can be submitted at any time. However, execution of the agreement will be held until the initial protocol is approved by the USC IRB, and USC has received all necessary information regarding the relying site(s).
If a participating site is relying on USC IRB, is the relying site required to submit to its own IRB?
It will depend on the other institutions’ processes. Relying sites may need to provide a submission their own IRB system, even if their IRB will rely upon USC IRB. Further information should be obtained from the relying institution’s IRB office.
I am a USC PI and want to serve as the Lead PI for a multi-site study. What do I need to do?
If another institution relies upon USC IRB, what responsibilities does the USC Lead PI and research staff have?
A USC investigator that agrees to become the Lead Principal Investigator over multiple sites obtains overall responsibility for the protection of human subjects for all relying sites in the study. Critical evaluation should take place to assure that the necessary resources and infrastructure are in place to support and lead a multi-site research project. Considerations includes the management and collection of all regulatory information needed by USC IRB, and the communication plan necessary to disseminate and receive all IRB-related matters between all sites. For example, if a reportable event occurs at a relying site, the site investigator is required to inform the USC Lead PI who is then responsible for forwarding the report to the USC IRB. The Reliance Agreement will identify the complete list of responsibilities for each institution.
Initial Study Submission: As the Lead PI for a protocol that will have external sites relying on USC IRB, what do I need to consider at the time of initial submission?
The USC investigator who agrees to be the Lead PI for a multi-site study will submit an iStar IRB application as usual. The iStar IRB application will require the names of the sites that will rely on the USC IRB for review and oversight.
Amendments: As the Lead PI for a protocol that will have external sites relying on USC IRB, what is required for amendments?
All amendments must be submitted, reviewed, and approved by the USC IRB before the relying site(s) can make any of the changes included in the amendment. Once the amendment has been approved by the USC IRB, all necessary documentation must be provided to the relying site(s).
Continuing Reviews: As the Lead PI for a protocol that will have external sites relying on USC IRB, what do I need to submit for continuing review?
The Lead PI is required to collect all information needed to complete the iStar continuing review submission form. The continuing review at USC IRB will be conducted for all sites. Therefore, all information such as enrollment numbers, reportable events, etc., must be collected from all relying sites and included in the USC iStar continuing review submission.
Unanticipated problems: As the Lead PI for a protocol that will have external sites relying on USC IRB, do I need to report unanticipated problem that occur at the external sites to the USC IRB?
Yes. All reportable events (unanticipated problems, deviations, suspensions and terminations, noncompliance, participant complaints, etc.) from any relying site should be reported to USC IRB. The USC IRB will review any issues submitted. The Lead PI at USC will forward necessary communication from the USC IRB to the relying site’s IRB of any such issues.
Consent forms: As the Lead PI for a protocol that will have external sites relying on USC IRB, do the relying sites use a USC consent?
The consent forms to be used at a relying site will be reviewed and approved by USC IRB. However, they should include site-specific information (headers, HIPAA/privacy language, injury language, contact information, etc.).
Documents: As the Lead PI for a protocol that will have external sites relying on USC IRB, what documents must be provided to the participating sites?
The USC Lead PI should provide all relying institutions with the following documents:
- The USC IRB approval letter
- The USC IRB approved protocol
- The USC IRB approved consent form (if there is one)
- The USC IRB Authorization Agreement for the relying site to sign (if necessary)
- Any other documents requested
What documents must the relying sites provide to the Lead PI and USC IRB?
The investigators at the relying site should provide the USC Lead PI and USC IRB with the following documents:
- The relying sites IRB approval letter
- The USC IRB Authorization Agreement signed by the relying institution for USC to sign (if necessary)
Who would be the IRB Designee to sign an agreement form?
The IRB Director: RoseAnn Fleming, email@example.com
For additional information please contact University of Southern California IRB at: