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Guidance
Feb 17, 2017

Tips on the REP Application and Supplement Form

An REP application must include an Application Supplement Form, uploaded in Section 08 . The Application Supplement Form, in combination with the eResearch Repository application (REP), to provides a comprehensive overview of the repository's...
Guidance
Feb 17, 2017

Responsibility for REP Oversight and Compliance

REP application and Application Supplement Form capture several different levels and types of information about a repository's processes and intents, including: information characterizing a repository to identify useful relationships for researchers...
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
Jul 20, 2015

eResearch Regulatory Management (eRRM)

eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.
Policies
May 1, 2015

Statement of Practice: Flexibility Initiative: Two-Year Approvals - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted a two-year approval may not be used to support proposals or future awards involving federal funding. Click here...
Policies
May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...
Policies
May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 2A - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Click here for PDF version.
Guidance
Apr 16, 2015

Unanticipated Problems Involving Risks to Subjects or Others

For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page. Also see the University of Michigan Human Research Protection Program...
Policies
Feb 27, 2014

Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study Documents . Click here for PDF version of the current document . When watermarking consent documents and recruitment...
Guidance
Aug 16, 2012

Forms

The forms below are designed for use with various IRBMED submissions.
Guidance
Oct 17, 2011

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED

04/23/2021: This page has been archived. Please refer to the more comprehensive pages: Certification Preparatory to Research Decedents De-identified Limited Data Sets
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
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...

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Phone: 734-615-1332
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Email: ummsresearch@umich.edu

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