Initiating a Reliance Agreement - WCG

When collaborating with external institutions on a study protocol, a Reliance Agreement may be necessary to undergo research. Please assess whether a Reliance Agreement is necessary by reviewing the materials below.

Definitions

Reliance Agreement: A formal document that enables a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. All institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.

Single IRB [sIRB]: An Institutional Review Board that oversees all sites participating in a multisite study.

Multisite: Under the NIH Single IRB Review policy, policy, “multisite” is defined as two or more sites.

Participating Site: A participating site in a multisite research study.

When to Use a Reliance Agreement:

Open

What happens next?

1. If using WCG, all external collaboration sites/institutions must complete an IRB Authorization Agreement also known as a Reliance Agreement. This form can be found through WCG.

2. Once completed by all external collaborators, a Sage governance analyst will submit these application forms through WCG.

3. Following the review and approval of the WCG IRB, a research protocol may be submitted for review.

Questions?

Contact Hayley Sanchez or Kimberly Corrigan for assistance.