Coordinated Services & Practices (CSP)

Welcome to Coordinated Services & Practices (CSP)

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.

IRB Harmonization

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.

[Harmonized Guidance/Procedural Documents] -> Link

Single IRB

IRB-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. 

[Single IRB Documents] -> Link

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.

  • IRBMED  Institutional Review Boards of the University of Michigan Medical campus
  • IRB-HSBS  Institutional Review Boards of the University of Michigan at Ann Arbor, Dearborn, and Flint
  • CSP – Coordinated Services & Practices in support of the University of Michigan IRBs

CSP STAFF

Lana Gevorkyan, MBA – Director, IRB Coordinated Services & Practices 

Nicole Robson, sIRB Team Lead and QA/QI Specialist

References and Resources

Questions?

Lana Gevorkyan, MBA

Director, IRB Coordinated Services & Practices

gevorkla@med.umich.edu(link sends e-mail)

734-763-1236

eResearch NextGen: Human Research Application

OHRP Research Community Forum

HRPP Policies

Operations Manual (OM)

Authorization Agreement Process

Office of Research Compliance Review (ORCR)

Single IRB-of Record Process (SIRB)

Certificate of Confidentiality Process

HRPP Education Resources

Information for the Public

International Research

IRB HEALTH SCIENCES AND BEHAVIORAL SCIENCES (HSBS)

IRBMED