Consortia and designated central IRBs

Applies to: Agreement V3.0

Yes, Version 3.0 can document reliance for a consortium, clinical trials network, or any arrangement with a designated central IRB — for one study or many, whether industry-funded or federally funded.

Whose rules apply. Under Version 3.0 (Article 3):

• If a federal regulation or funding policy prescribes how reliance is initiated or how the Reviewing IRB is chosen (Mandated Processes), or a federal department or agency prescribes how the relationship is conducted (Mandated Policies), those govern — a Mandated Policy prevails over any conflicting Agreement term.
• Otherwise, the network's or central IRB's terms of participation can be adopted as the Other Policies for the arrangement, and the institutions must document that choice with one another (undocumented, the SMART IRB SOPs apply). Where an Other Policy conflicts with the Agreement, the Agreement governs. This is a change from earlier versions, under which network or funder terms overrode the Agreement.
• Network or funder terms that affect the reliance relationship should be communicated to Relying Institutions in writing.

How to document it. Use the Implementation Checklist to record consortium-level flexible arrangements once — for example, HIPAA responsibilities already settled in a consortium agreement, or the SOPs the network follows — rather than study by study.

One Reviewing IRB or several. A consortium may use one central IRB, or more than one where sites decline to rely on the designated IRB or where subject populations or procedures differ substantially. Each Reviewing IRB needs its own reliance request in the Reliance System.

See also - The SMART IRB SOPs: what they are and when they apply - The Implementation Checklist - Selecting the Reviewing IRB