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Research

Reliance agreements

What is a reliance agreement?

A reliance agreement is a formal agreement that allows an institution engaged in research to delegate or cede IRB oversight of a research study, or group of studies, to an independent IRB or IRB at another institution.

The following arrangements occur under such agreements:

  • The Medical College of Wisconsin is the primary IRB of record
  • Children's Wisconsin may defer IRB oversight to an external IRB to serve as the reviewing IRB

Reliance agreements may also be referred to as IRB Authorization Agreements (IAAs). The arrangement of one IRB relying on another IRB may also be referred to as deferring to a central or single IRB (sIRB), deferring IRB oversight, or relying on an external IRB.

Why might I need a reliance agreement?

The National Institutes of Health has required that a single IRB review NIH-funded multi-site studies that were approved on or after January 25, 2018. Additionally, under the Revised Common Rule, most US Government funded cooperative studies that meet the criteria for non-exempt human subjects research and involve more than one site will also require single IRB review. This requirement went into effect on January 20, 2020. In addition to these required scenarios, there may be instances where an investigator believes that their study would be best reviewed by one IRB.

How do I initiate a reliance agreement?

Researchers may be permitted to enter into a reliance agreement upon request. Determinations are made on a case-by-case basis by department staff.

Reliance requests can be initiated using eBridge.

Established reliance networks and platforms

The Children's Wisconsin HRPP maintains reliance agreements for designating IRB review between collaborating institutions and independents/external IRBs.

Examples of established networks and platforms that Children's can utilize include: