The process to rely on an external IRB begins with the reviewing IRB.
The lead PI at the external institution should follow their IRB’s procedure to begin the reliance request process.
Once the reviewing IRB has agreed to act as the reviewing IRB, its staff members will instruct the lead PI on their process for communicating with relying sites.
Follow the steps below regardless of whether the external IRB is an academic IRB or a commercial IRB.
Before research activities can begin, the UIUC PI must have an IRB approval letter from the reviewing IRB and an Human Research Protection Program Activation letter from UIUC via OPRS.
Once the UIUC PI has received information about the study from the lead PI and/or reviewing IRB, the UIUC PI should submit a Reliance Consultation Request to begin the process at UIUC.
OPRS will schedule a meeting to discuss the project with the UIUC researchers. At this meeting, OPRS will ask questions to learn more about the project in order to determine if the sIRB process is appropriate and will provide the UIUC researchers more information about the process and their responsibilities.
If OPRS agrees that the sIRB process is appropriate, its staff members will begin the reliance agreement negotiation process with the reviewing IRB. OPRS handles all reliance agreement management and signatures.
Once the UIUC PI has a draft of the protocol and consent document, the Human Research Protection Program review process can begin at UIUC. To initiate the HRPP review at UIUC, the UIUC PI must submit a Facilitated Review application via the IRBOnline system. After the UIUC PI submits the Facilitated Review application, OPRS will conduct the HRPP review. At this point, OPRS will provide the reviewing IRB with the HRPP review and local context information. OPRS will send the application back to the UIUC PI with a revision request to attach the sIRB approval letter once UIUC PI receives it from the reviewing IRB.
The UIUC PI submits the UIUC site information to the reviewing IRB for its review and approval. The lead PI will be included in those communications. The reviewing IRB will approve UIUC as a site and approve UIUC’s consent documents, if applicable. The UIUC PI will receive an IRB approval letter from the reviewing IRB, please note that the reviewing IRB approval letter must clearly indicate that it approved UIUC as a site.
The UIUC PI attaches the reviewing IRB’s approval letter as well as the approved consent documents to the Facilitated Review application and re-submits it to OPRS via the IRBOnline system for final activation. OPRS will confirm all local requirements have been made and will send the UIUC PI an HRPP Activation Letter. Following receipt of the HRPP Activation letter, UIUC researchers may begin their research activities.