04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...

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...

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

The study protocol should comprise all the key information about study conduct, including but not limited to rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study...

07/12/2021: This page has been archived.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...

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...

The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6(R2) Guidelines. International Council for Harmonisation (ICH) Good Clinical Practice ( GCP ) standards (ICH-GCP) standards are fully...

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...