Guidance
Mar 13, 2020

Urgent Amendment Procedures

Update March 16, 2020: The process outlined below for urgent Amendments is being temporarily suspended until further notice. IRBMED has published new procedures and a workflow diagram for time-sensitive and urgent modifications to active research...
Guidance
Apr 9, 2019

Elements and Uses of a Repository

A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...
Policies
Mar 11, 2019

Statement of Practice: PEERRS Certification Requirements

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...
Guidance
Jan 16, 2019

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...
Guidance
Jan 16, 2019

Transition to 2018 Regulations

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...
Guidance
Jun 11, 2018

Adverse Event Reporting

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...
Guidance
Jun 11, 2018

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
May 22, 2018

UMMS Biorepository Registration Decision Tree

This decision tree represents UMMS policy for registration of biorepositories funded by a UMMS Department , and/or operating in UMMS space, and/or directed by faculty with an appointment in the Medical School. For more information, see University of...
Templates
May 4, 2018

Data Office Data Request Form

To request data, complete a Data Request Form, which includes IRB information (if applicable), study team information and where you will store your data. Note: You may save your work and submit at a later time
Tags: Data Use
Templates
Mar 13, 2018

Data Office Access Request Form

Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at dataoffice@umich.edu .
Tags: Data Use
Templates
Mar 13, 2018

Data Office Data Set Specification

To request data, complete a Data Set Specification to define your subject population (inclusion/ exclusion criteria) and the data elements needed in your data set. Note: You may save your work and submit at a later time
Tags: Data Use
Policies
Jun 15, 2017

Institutional Review Board Oversight Policy

This policy is to ensure that Central Biorepository (“CBR”) operations, and research projects facilitated by the CBR, undergo appropriate ethics committee review to protect human research subjects.
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...

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