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Institutional Review Boards (IRBs)
As part of the HRPP, the primary goal of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Michigan.
Lana Gevorkyan, MBA – Director, IRB Coordinated Services & Practices
Nicole Robson, sIRB Team Lead and QA/QI Specialist
Welcome to Coordinated Services & Practices
CSP provides an oversight structure and supports IRB harmonization and single IRB efforts as part of the Human Research Protection Program (HRPP)
As a partner to IRBMED and IRB-HSBS, CSP will assist in developing centrally coordinated services & practices and store relevant procedural and guidance documents in a central location.
U-M IRBs are collaboratively evaluating current standardization practices and developing harmonized guidance documents to reflect a unified process. The CSP works closely with UM IRBs Leadership to assess IRB practice and guidance differences.
The IRBs have harmonized several routine procedural guidance and are gathering more information to address additional procedural workflows due to the eResearch NextGen project. Our goal is to create plans to harmonize applicable practices while ensuring a minimum disruption in workflow changes. As those assessments occur, existing practice/guidance documents that are already similar will be harmonized as a first step.
CSP has been working on further developing joint IRB review procedures associated with a single IRB (sIRB) for accepting and ceding IRB of Record arrangements. The sIRB team, comprised of U-M IRB staff, reviews and finalizes guidance documents associated with IRB workflows. CSP is in the planning stages of creating education sessions and other learning opportunities associated with procedures for accepting and ceding IRB oversight.
References and Resources:
Single IRB related: