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...

Overview The Food and Drug Administration (FDA) regulation at 21 CFR 50.24 , and Office for Human Research Protections (OHRP) Secretary's Waiver , allows a narrow exception to the requirement to prospectively obtain and document informed consent...

Research records include, but may not be limited to, consent forms case report forms (CRFs) subject-specific forms for adverse events, notes to file, and protocol deviations Record retention must be consistent with IRB-approved methods for data...

Many investigators have expressed uncertainty concerning when consent should be obtained from a subject who is being evaluated for possible eligibility to participate in one or more clinical trials. The following guidance has been developed to...

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...

Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...

This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M is a coordinating center is not the single IRB (sIRB)/IRB of record/reviewing IRB for sites other than U-M...

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...

sIRB Timing, Fees and Budgeting When requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date. See section “IRBMED as the sIRB (accepting oversight)” of this guidance...