Coordinated Services & Practices (CSP) – Human Research Protection Program

Welcome to Coordinated Services & Practices

As part of the U-M Human Research Protection Program (HRPP), CSP an oversight structure supports the harmonization of IRB practices and single IRB efforts.

The CSP partners with the U-M IRBs to identify common workflows where IRB practices may be standardized with a goal of providing harmonized process guidance for both study teams and IRB staff. CSP assists in developing centrally coordinated services and stores 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.

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.

CSP – Coordinated Services & Practices in support of the University of Michigan IRBs
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 Staff

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

Nicole Robson, sIRB Team Lead and QA/QI Specialist

Single 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.

For additional sIRB information and resources, see the IRB websites:

IRBMED: Single IRB (sIRB) and Cooperative Multi-Site Research

IRB-HSBS: Collaborative Research

Accepting – U-M Single IRB

Ceding (relying on external IRB)

External Collaborators

Protocol Tools

A study protocol is a key resource for study teams, study sponsors, and research support units including the IRB and ancillary committees. A protocol should comprise all the key information about the study conduct, including but not limited to the rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study design fulfills applicable regulations, and how oversight is provided.

While having a stand-alone study protocol document is optional (excluding clinical trials), the HRPP encourages the use of a stand-alone protocol document for all human research studies as a best practice. A well-written stand-alone protocol document supports:

Efficiency and Compliance: Encourages efficient IRB review and supports regulatory compliance and facilitates study team education about human research protections.
Quality and Adherence: Minimizes deviations in study conduct, ensures best practices, and protects participants.
Scientific Rigor: Supports scientific rigor, reproducibility, and facilitates addressing primary aims.
Operational Effectiveness: Facilitates compliant conduct of the research.
Adaptability: Helps study teams navigate complex study designs and changes in research regulations.
Publishing Best Practice: Some scientific journals require a written protocol with submission of research articles.
Clinical Trial Requirements: As part of the NIH clinical trial registration and results reporting regulations and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), a written protocol must be uploaded to the study’s registration record in ClinicalTrials.gov at the time of results submission.

To support study teams, the HRPP has developed the following protocol templates and checklists:

U-M Protocol Templates:

IRB-HSBS Exempt Protocol Template

FDA Regulated Clinical Trials Protocol Template (available through MICHR)

Non-FDA Regulated Clinical Trials Protocol Template

Qualitative Human Research Protocol Template

General Human Research Protocol Template

Protocol Checklists:

Each protocol checklist listed below outlines the key information necessary for IRB review based on the type of research. These checklists complement the corresponding U-M protocol templates. They can also be useful tools for researchers using an alternative protocol template or who already have a pre-existing protocol and are seeking to assess its comprehensiveness.

Non-FDA Regulated Clinical Trials Protocol Checklist

Qualitative Human Research Protocol Checklist

General Human Research Protocol Checklist

Questions and Input:

See the Protocol Tools FAQ for additional guidance.

Your input will assist the HRPP in refining the U-M protocol templates and checklists, developing additional guidance, and identifying process improvement opportunities. Complete the feedback form, or email your feedback to HRPPProtocolToolsSupport@umich.edu.

For Protocol Tools & Templates questions, contact HRPPprotocoltoolsSupport@umich.edu.

For IRB process questions, contact your IRB Office.

Research Collaboration within U-M Health Statewide Network of Care

Conducting clinical research throughout the U-M Health Statewide Network of Care requires significant coordination. U-M researchers from Ann Arbor, Dearborn, or Flint who are interested in conducting research at any of the U-M Health Statewide Network locations will need to document the collaboration in their eResearch application. The details depend on whether the U-M Health Network of Care site will be engaged in the research activity and who will be providing IRB oversight (IRBMED, IRB-HSBS or an external IRB). Procedural requirements for working with U-M and external IRBs are outlined in Research Collaboration With U-M Health Network of Care guidance document.

In addition to IRB regulations, researchers must adhere to additional administrative and policy requirements when working across U-M Network of Care sites. For more details on research collaboration and conducting clinical research throughout the U-M Health Statewide Network of Care, please visit U-M Health Statewide Clinical Research Partnerships