How a reliance request moves through the system

Applies to: Reliance System

A reliance request is the record of one study, one proposed Reviewing IRB, and the sites that will rely on it. Here is the path from submission to determination letter, and what each status means.

1. Draft → Under Review. Anyone with permission creates the request (see Create a reliance request) and submits it. Site Admins at the Overall PI's Home Institution are notified.

2. Reliance pre-check. A Site Admin at the Home Institution checks that the study is appropriate for reliance and marks it Eligible or Not Eligible. If changes are needed first, the Site Admin can Request Revisions, which returns the request to the submitter (Action Required).

3. Right of first refusal. The Home Institution decides whether its own IRB will serve as Reviewing IRB. If it agrees, the request moves to Reviewing IRB Identified. If it declines, its Site Admin proposes another Reviewing IRB — often the one the submitter requested — and that institution accepts or declines. If no IRB can be identified the request becomes Reviewing IRB Not Identified and the Home Institution and Overall PI look for alternatives (see Selecting the Reviewing IRB).

4. Site decisions. Each involved site's Site Admins are notified. Before deciding, they (and the site's listed research personnel) can review and correct their own site's details. They then record whether the institution is willing to rely on the identified Reviewing IRB: a yes can carry local considerations for the Reviewing IRB; a no carries a reason. The Reviewing IRB can nudge slow sites with Remind Site. As soon as one site has decided, the status is Reliance Forms Submitted.

5. Determination — per site. The Reviewing IRB confirms each site's reliance and the system issues a determination letter for each site. Reliance Reached means at least one site has agreed to rely and the Reviewing IRB has issued its letter; Reliance Not Reached means a site declined and a denial letter was issued. Request states apply to the whole request, but determinations are made site by site, so a late-added site goes through step 4 on its own while the rest of the request is already Reliance Reached.

6. For the life of the study. The request stays active. Sites can be added at any time, site investigators and personnel can be updated at any time (the determination PDF updates automatically), and study documents can be replaced as the protocol or consent changes. See Edit a request.

Statuses at a glance

Where to see it. All Requests (Site Admins see every request involving their institution; other users see requests they submitted or are listed on) and the Reliance Dashboard; expand a request for its activities and history log.

See also

• Create a reliance request
• Selecting the Reviewing IRB
• After the reliance determination