The Reliance Manual (RM) is designed to guide you through the policies and processes related to single IRB review, collaborative research, and institutional requirements. The manual includes step-by-step descriptions of the most common reliance agreement processes. The manual also provides comprehensive guidance on ceding IRB review as well as UW-Madison serving as the reviewing IRB for external sites and individuals.

Reliance Manual

The Reliance Manual has 5 parts. Click a link to review a particular part, or download the RM from the References & Resources section below.

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Part 1: Introduction – Describes the scope & purpose of the RM and an introduction to the Reliance and Navigation Team (RELIANT).

Part 2: UW-Madison as Reviewing IRB or Single IRB – Describes Single IRB requirements, letters of support and cooperation, engagement determinations, selecting the best reviewing IRB option, when UW-Madison will review for external sites and individuals, developing protocols, applications, and study materials for studies involving external sites and personnel, community-based research requirements, training requirements, types of reliance agreements, the reliance process, and investigator responsibilities.

Part 3: UW-Madison Relying or Ceding IRB Review – Describes engagement, HIPAA considerations, types of external IRBs, international ethics boards, preparing study materials, protocols, and site supplements, how and when to submit a cede request, the reliance process, and investigator responsibilities.

Part 4: Other – Describes UWHC partners and affiliates, VA requirements, and sending or receiving specimens.

Part 5: Appendices – Includes the Single IRB Matrix, IRB liaison job description, and a communication plan template.


References & Resources

Last Updated: March 19, 2021

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