Human Research Protection Program (HRPP)
Process to Rely on a CIRB/SIRB↓
Institution’s HRPP representative receives a reliance invitation letter from CIRB/SIRB and/or a reliance consultation request from one of their local principal investigators/study teams.
The relying HRPP schedules a consultation with their investigator to discuss the relevant terms/requirements of the proposed reliance relationship. A representative from the lead site study team and CIRB/SIRB may also attend at the discretion of the HRPP.
The relying HRPP responds to the CIRB/SIRB by either:
a) agreeing to rely by sending a Reliance Decision Letter or a signed Reliance Agreement to the CIRB/SIRB so they can proceed with their review, or
b) declining to rely by notifying the CIRB/SIRB and the local investigator of the determination.
(If reliance is declined, the investigator proceeds with usual local IRB review, and the CIRB/SIRB process stops here.)
While the relying HRPP and CIRB/SIRB complete reliance negotiations according to their local policies and procedures, the relying HRPP submits their Local Considerations Package to the lead site investigator and CIRB/SIRB so site-specific materials (e.g. consent documents, recruitment materials, etc.) can be prepared.
While the lead site investigator pursues CIRB approval to add the relying site to the application, the investigator submits an application to the relying HRPP to initiate HRP Review.
At a minimum, the HRP review application should include:
a) A copy of the protocol.
b) A copy of the consent document template. Note: It is not necessary to include site-specific consent language in the document at this point, since the relying HRPP can assume their required language will be inserted into the final, CIRB-approved version of the document, as outlined in the steps following.
c) Recruitment materials that will be distributed in the relying HRPP’s local community.
d) A copy of the CIRB approval for the overall study.
The relying HRPP conducts their Local HRP Review according to their own policies and procedures. When Local HRP Review has progressed as far as it can without the final, CIRB-approved documents for their local site, the relying HRPP sends a notification to the study team requesting the final, CIRB-approved documents, which must include:
a) The CIRB-approved version of the site-specific consent document which includes required information from the Local Considerations Package, if any.
b) The CIRB approval to add the local site to the study.
When the CIRB-approved documents are submitted to the relying HRPP, the HRPP completes their Local HRP Review, and notifies the investigator that the study has been activated at the relying site. The investigator should forward the HRPP activation letter to the CIRB/SIRB and retain a copy for their own research records.