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
Guidance
Jun 7, 2021

Other Reportable Information or Occurrence (ORIO)

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...
Guidance
Mar 8, 2021

Record Keeping Guidelines

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...
Tags: Regulatory Study Coordinator Study Teams
Guidance
Dec 15, 2020

Reporting Time-Sensitive Modifications

PDF Version Revised 12/14/2020 NOTE: The following guidance does not apply to studies where IRBMED is relying on an external IRB for regulatory oversight ("ceding" IRB oversight). If your study is ceded, you must reach out to the IRB of Record for...
Guidance
Jul 10, 2020

eResearch Cross-Reference Table

These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...
Guidance
Apr 8, 2013

Lotteries as Incentives for Research Participation

Researchers may incentivize study subjects by entering their names in a lottery operated by the study team. If a study’s incentive budget is small, a lottery allows one subject, drawn at random from the pool, to receive the full amount of the...
Guidance
Jul 29, 2020

Seeking Reconsent from Research Participants

Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...
Guidance
Jul 8, 2020

Exempt Human Subjects Research

This page contains information regarding human subjects research that falls within the federal exemption categories or U-M exemption categories . Exempt human subjects research does require an application and determination in the eResearch system...
Policies
May 26, 2017

Statement of Practice: Sections 15 and 16 of IRB Application

Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...
Guidance
Jul 14, 2016

Resources - ARCHIVED

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...

Pages