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A Single IRB (sIRB) is the IRB-of-Record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site, collaborative human subjects study. Common Rule agencies/funding sponsors (e.g., NIH) require an sIRB for domestic multi-site, collaborative studies.
- Collaborative Research: IRB-HSBS sIRB Process
- External sIRB Fee Schedule Depicts a sample budget worksheet outlining the fees for services that may be charged by an external (e.g., commercial) institutional review board (IRB) when that IRB is serving as the single IRB-of-record (sIRB) for a multi-site non-exempt human subjects project.
- IRB Authorization Request - U-M as a Relying IRB IRB-HSBS form to request establishing IRB authorization agreements for multi-site, collaborative projects where U-M will cede oversight to an external sIRB and be a relying institution for the project. Last updated 05/05/2020.
- IRBMED webpage: sIRB and Multi-site Research (MSR) Guidance
- Lead PI/Study Team Guidance and Checklist IRB-HSBS checklist of actions the U-M PI/study team needs to complete to establish and manage a multi-site, collaborative project where U-M will be the IRB-of-Record (sIRB). Last updated 04/02/2020.
- Relying on an External IRB - FAQs FAQs for U-M study teams ceding IRB review to an external IRB. Last updated: 04/23/2020.
- Reviewing IRB Instructions to Relying Sites IRB-HSBS guidance and template for relying sites and study teams engaged in a multi-site collaborative project where U-M is the single IRB-of-Record (sIRB). Last updated: 04/02/20.
- Single IRB Review Core - Features and Guidelines (MiCORES) Overview of the sIRB Core tabs and features, including MiCORES account set-up details. Last updated: 02/04/2021
- sIRB Communication Plan Template IRB-HSBS template, based on the SMART IRB model, to develop the communication plan required for multi-site projects with three or more engaged external sites. Last updated 04/23/2020.
- UMICH Single IRB Review Core (MiCORES login) Link to go to the sIRB Core upon authentication to MiCORES (UMICH login required)
Enterprise
Enterprise
As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.
The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.
ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.
Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).
eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).
Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.
