When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in...

The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM) . The IRBMED Standard Operating Procedures serve as a reference for investigators , IRBs,...

This document provides guidance on the monitoring requirements for non-significant risk (NSR) device studies that are initiated by UM investigators and under IRBMED oversight . It also provides instructions on completing the IRB application for the...

This page contains information regarding human subjects research that falls within the federal exemption categories or U-M exemption categories . Exempt human subjects research does require an application and determination in the eResearch system...

This policy sets forth the Michigan Medicine policy on Research Fellow appointments. Effective April 1, 2023.

Convened Board 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)...

The table below presents instructions and guidance on reporting complaints from subjects or others.

04/23/2021: This page has been archived. Please refer to the more comprehensive Exempt human subjects research and Federal Exemption Categories pages.

This policy describes the threshold over which the establishment of subaccounts is expected for inter-unit research projects at the Medical School. This policy formalizes existing practice within the School and conforms to the usual expectations for...