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Institutional Review Board - Health Sciences & Behavioral Sciences
- Collaborative Research: IRB-HSBS sIRB Process
- Continuing Review Process
- Data Security Guidelines
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including system generated determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Incident Reporting (AE/ORIO)
- Informed Consent Guidelines & Templates
- Introduction to Human Research Protection: A Guide for Student Investigators Last Updated: March 2019
- IRB Amendment Process
- IRB Application Process
- IRB Health Sciences and Behavioral Sciences (HSBS)
- IRB Repository Application Supplement Template that outlines the information necessary for IRB review of a U-M data/biospecimen repository. Complete and upload to the IRB Repository Application within the eResearch Regulatory Management System (eRRM).
- IRB Repository Application: eResearch Job Aids Webpage with links to step-by-step instructions to create and submit an REP, amend an REP, file a continuing review, and terminate an REP. Provided by ITS.
- IRB Review Process
- IRB-HSBS Education
- IRB-HSBS Exempt Protocol Template A suggested brief template for exempt protocols.
- IRB-HSBS: Key Changes to the Common Rule IRB-HSBS general session presentation (updated 10/12/2017) explaining key changes in the 2018 Common Rule (Regulations for the Protection of Human Subjects ~ 45 CFR 46)
- OHRP Repository Guidance Issues to Consider in the Research Use of Stored Data or Tissues (1997)
- Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
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.