Coordinated Services & Practices (CSP)
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
CSP works closely with U-M IRBs to align current practices with a goal to develop harmonized guidance documents to reflect a unified process.
To date, the IRBs have harmonized several routine procedural guidance and are gathering more information to address additional procedural workflows. 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.
For IRB Harmonized guidances, scroll down to the resources section of this page.
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 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.
For additional sIRB guidance, scroll down to the resources part of this page. If those documents do not cover what you are looking for, see the IRB websites for more information:
sIRB Education:
The CSP team is currently developing educational sessions and other learning opportunities focused on the processes for accepting and ceding IRB oversight in multi-site research.
sIRB Quality Assurance and Quality Improvement:
University of Michigan’s Institutional Review Boards (IRBs) serve as the IRB of record for certain multi-site studies and, in other cases, cede IRB oversight to external IRBs. To ensure compliance with IRB requirements and to verify that study teams are adhering to approved protocols and guidance, the CSP conducts periodic quality assurance (QA) reviews of these multi-site arrangements.
These QA reviews are independent of both the Office of Research Compliance Review’s (ORCR) Routine Reviews and For-Cause Reviews. CSP evaluations generally focus on one or more of the following key areas:
Informed Consent Forms (ICFs): CSP will request the current version of the ICF to confirm the use of the most recent IRB-approved documents, including both Part 1 and Part 2 when applicable.
Reportable Events timeline: CSP will assess whether reportable events were submitted within the required timelines set by the IRB of record.
Protocol Adherence: The version of the protocol used by the study team will be compared against the latest IRB-approved version to ensure alignment.
Data Management: Data security measures will be reviewed in the context of the approved protocol and application. This includes confirming that the study team(s) have appropriate agreements (e.g., Data Use Agreements, Data Transfer Agreements, Material Transfer Agreements) in place.
Conflict of Interest (COI) Management Plans: CSP will review applicable COI management plans to ensure compliance with all required stipulations.
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
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:
General Human Research Protocol Template
Qualitative Human Research Protocol Template
Non-FDA Regulated Clinical Trials Protocol Template
FDA Regulated Clinical Trials Protocol Template (available through MICHR)
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.
- General Human Research Protocol Checklist
- Qualitative Human Research Protocol Checklist
- Non-FDA Regulated Clinical Trials 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 [email protected].
For Protocol Tools & Templates questions, contact [email protected].
For IRB process questions, contact your IRB Office.
References and Resources
IRBMED ONLY – sIRB Consent Template
External Site
Payments to Research Participants
The University of Michigan recognizes the importance of encouraging individuals to participate in research and values the time, effort, and risk participants contribute to university research efforts and therefore allows incentives to be provided to participants as compensation for participating in a research study. Incentives may be monetary in nature or other gifts/prizes may be used. Participants may also be reimbursed for out-of-pocket expenses that they incur related to their participation in research. For additional information, please refer to the guidance.
According to federal regulations, an IRB is required to protect the welfare of human participants during the conduct of research and to ensure the participants are not unduly influenced. Incarcerated persons are considered a vulnerable population. IRB review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated, is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule) and C (Additional Prisoner Considerations) prior to any interaction or intervention with prisoners or research participants who are now classified as prisoners, as well as data about prisoners. For additional information and guidance, please refer to Research Involving Prisoners Guidance.
Research involving children requires that adequate provisions are made for soliciting the assent of the child and the permission of their parents or guardians consistent with the standards described in 45 CFR 46.408.
Children who reach the age of majority while participating in a study must be consented if continuing interventions or interactions are planned (including collection or analysis of identifiable private information), as described in 45 CFR 46.116. The IRB may grant a waiver of consent under 45 CFR 46.116 (e), if it finds that required conditions are met, but must document its decision and rationale for doing so. For considerations of age for obtaining and documenting assent, please refer to Assent Age Ranges Guidance.
Data and Safety Monitoring Plan
Researchers are required to develop a Data and Safety Monitoring Plan appropriate in scope to the anticipated risks of the research. The method and extent of monitoring may vary across different types of studies, depending on multiple factors, including the experimental design and complexity of the study (e.g., Phase I vs. Phase III trial vs. a descriptive psychosocial interview study), and the degree of risk to subjects. Various funding sources also may have additional requirements related to data and safety monitoring which must be considered. For additional information, please refer to the DSMP guidance.
Communications play a critical role in recruiting research study participants. There are two types of content that appear in research-related recruitment communications: study-specific communications that require IRB approval and communications that do not require IRB approval.
According to federal regulations, an IRB is required to protect the welfare of human participants participating in research and, specifically, to determine that the selection of participants to participate in the project is equitable and free from coercion. As an essential part of this process, the IRB must review and approve any advertisement for recruiting research participants to a research project before it can be distributed to potential participants. For additional information, please refer to the Recruitment Communication Guidance.
Questions?
Lana Gevorkyan, MBA
Director, IRB Coordinated Services & Practices
[email protected]
734-763-1236
Related Information
HRPP Related Processes
- Single IRB-of-Record (HRPP)
- Authorization Agreements (HRPP)
- Certificates of Confidentiality (HRPP)
- Investigational New Drugs and Devices (IRBMED)
- IRB Enrollment Definition (UMOR)
- Sensitive Data Guide (ITS Safecomputing)
- IRB application (eResearch)