This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...

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This document replaces the August 22, 2018 "PEERRS Certification Requirements" document. Click here for PDF version. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where...

04/23/2021: This page has been archived. This transition is largely complete. All new applications are evaluated according to 2018 Revised Common Rule. With questions, contact your IRB staff. On January 21, 2019 most provisions of the Revised Common...

The IRBMED office prefers eResearch correspondence as a means of communication between IRBMED and study teams. Other communication options include phone, email, and in-person consultations. Click here for PDF version.

Expedited Category (5) pertains to research involving data/materials that have been collected previously for research or non-research purposes and/or will be collected solely for non-research purposes, provided that certain criteria are met. Click...

Investigators and research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and...

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency...