07/12/2021: This page has been archived.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

This policy operates subject to the University of Michigan Medical School ( UMMS ) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition Within All UMMS Research Biorepositories (“UMMS Tissue Ownership Policy”) and applies to...

When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in...

Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. This guidance is intended for research studies that...

The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow. Children are persons who have not attained the legal age for...

12/15/2021: This page has been archived. See Electronic Informed Consent and Waivers under OHRP, FDA and HIPAA pages for up-to-date information on similar topics. In most cases, a potential research subject (or subject's representative) must be...

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule governs the use and release of a patient's personal health information, also known as Protected Health Information (PHI) , by a covered entity . To use and/or disclose PHI...

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...