URochester Relying on External IRB - Office for Human Subject Protection

How to begin

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.

**IRB Approval Letter and University of Rochester HRPP Activation Letter Required Before Research Begins**

Before research activities can begin, the University of Rochester PI must have an IRB approval letter from the reviewing IRB and a Human Research Protection Program Activation letter from University of Rochester via CLICK IRB.

Contact OHSP

Steps to Rely on External IRB

Step 1: Reliance Consultation Request

A Reliance Consultation Request is REQUIRED when relying on an academic IRB, or if it is the PI’s first time relying on an external IRB. Consultation is not required if relying on a WCG, Advarra, or NCI Central IRB, AND the PI has prior experience relying on these external IRBs.

Once the University of Rochester PI has received information about the study from the lead PI and/or reviewing IRB, the University of Rochester PI should submit a Reliance Consultation Request to begin the process at University of Rochester, if required.

OHSP will schedule a meeting to discuss the project with the University of Rochester researchers. At this meeting, OHSP will ask questions to learn more about the project in order to determine if the sIRB process is appropriate and will provide the University of Rochester researchers with more information about the process and their responsibilities.

Step 2: Reliance Decision

If OHSP agrees that the sIRB process is appropriate, its staff members will begin the reliance agreement negotiation process with the reviewing IRB. OHSP handles all reliance agreement management and signatures.

Step 3: Institutional Review Application

Once the University of Rochester PI has the IRB approved protocol and consent template, the Human Research Protection Program review process can begin at University of Rochester. To initiate the HRPP review at University of Rochester, the University of Rochester PI must submit an Institutional Review application via the CLICK IRB system. After the University of Rochester PI submits the Institutional Review application, OHSP will conduct the HRPP Institutional Compliance review. At this point, OHSP will provide the reviewing IRB with the HRPP review and local context information. OHSP will issue a Cede notice to the University of Rochester PI, and the study will enter the “Pending sIRB Review” state in CLICK IRB.

Step 4: IRB Approval

The University of Rochester PI submits the University of Rochester site information to the reviewing IRB for its review and approval. The lead PI should be included in those communications. The reviewing IRB will approve University of Rochester as a site and approve University of Rochester’s consent documents, if applicable. The University of Rochester 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 University of Rochester as a site.

Step 5: URochester HRPP Activation

The University of Rochester PI attaches the reviewing IRB’s approval letter as well as the approved consent documents to the Institutional Review application and re-submits it to OHSP via the CLICK IRB system for final activation. OHSP will confirm all local requirements have been met and will issue a site activation notice to the University of Rochester PI. Following receipt of the HRPP Activation letter, University of Rochester researchers may begin their research activities.