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Updating IRB applications when Researcher(s) Leave U-M

When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications.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

Tags: Regulatory Principal Investigator

Policies

Nov 17, 2022

Statement of Practice: IRBMED Communication Methods for Study Teams

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.

Guidance

Aug 31, 2022

Emergency Research (Planned and Approved) with Exception from Informed Consent

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...

Tags: Regulatory

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Guidance

Jul 24, 2007

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

The probability* and magnitude of harm or discomfort anticipated in the research and not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or...

Guidance

Aug 14, 2015

External Adverse Event (AE) Reporting

This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non -UM investigators and non -UM IRBs , events about which the UM investigator receives a report, usually from the study sponsor...

Guidance

Aug 26, 2022

Radiation Exposure Guide

Ionizing radiation includes x-rays, beta-rays, gamma-rays, neutrons, and other high-speed particles. When subjects are exposed to ionizing radiation as part of their study activity, the risks incurred from radiation exposure must be assessed by the...

Tags: Regulatory Study Teams

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Updating IRB applications when Researcher(s) Leave U-M

Statement of Practice: IRBMED Communication Methods for Study Teams

Emergency Research (Planned and Approved) with Exception from Informed Consent

Most Viewed

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

External Adverse Event (AE) Reporting

Radiation Exposure Guide

Medical School Office of Research