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...

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency...

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...

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS...

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...

“Post-Award” comprises everything that happens to administer a research project, following the official award being received. The following pages contain resources, tools and guidance that is available to assist our Research Administrators with...

This template should be used when creating a Survey Research informed consent document. This template may be used only for studies that involve a survey and no other procedures pose minimal risk to subjects

The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at...

This policy aims to ensure that donor preferences are given due respect in the conduct of research projects that are facilitated by the Central Biorepository (CBR). It operates subject to the UMMS Policy Governing Tissue Sample Collection, Ownership...