This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...

This guidance describes the circumstances regarding Emergency Use of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product. Emergency...

07/12/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant internal and external resource websites. The lists below provide direct links to resources both within the University of Michigan and outside the...

Human subjects research applications received by IRBMED include clinical investigations of therapeutic products that propose to utilize in vitro diagnostic (IVD) tests or assays. PDF version

Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED . Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in...

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if...

This guidance document outlines IRB expectations for research involving genetic analysis which generates or uses human genetic information through analysis of human biospecimens and/or data. For this guidance, the relevant human genetic information...