On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...

Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...

This decision tree represents UMMS policy for registration of biorepositories funded by a UMMS Department , and/or operating in UMMS space, and/or directed by faculty with an appointment in the Medical School. For more information, see University of...

REP application and Application Supplement Form capture several different levels and types of information about a repository's processes and intents, including: information characterizing a repository to identify useful relationships for researchers...

eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.

For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page. Also see the University of Michigan Human Research Protection Program...

Urgency is based solely on urgent health needs of one or more subjects. Sometimes situations arise which, while they do not meet the magnitude to constitute "an apparent immediate hazard," they do require changing the research in some way on an...