Operations Manual — The University of Michigan Human Research Protection Program Operations Manual (OM) is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and other members of the research community. Expect updated version in early 2018 due to regulatory and policy changes.
Standard Operating Procedures — The Institutional Review Boards of the University of Michigan Medical School Standard Operating Procedures (SOPs) serve as the overarching guidelines for IRBMED practices and procedures. Expect updated version in early 2018 due to regulatory and policy changes.
Glossary — The IRBMED Glossary is a compilation of regulations, terms, and acronyms related to human subjects research. The contents of this glossary have been collected from a variety of authoritative sources.
Plain Language Medical Dictionary — This is a project of the University of Michigan Taubman Health Sciences Library as part of the Michigan Health Literacy Awareness project.
Electronic Records and Electronic Signatures (21 CFR Part 11) — Part 11 provides criteria under which FDA will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures.
To find guidance on a particular topic, you may either click on one of the following letters or scroll down through the alphabetical listing.