I am a USC PI and want to serve as the Lead PI for a multi-site study. What do I need to know?
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.
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).
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).
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?
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.
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.
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).
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.
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.
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.).
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
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)
The IRB Associate Director: RoseAnn Fleming, email@example.com
For additional information please contact University of Southern California IRB at: