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 It is obsolete as of June 11, 2018.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 It is obsolete as of June 11, 2018.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 It is obsolete as of June 11, 2018.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 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 May 5, 2002 IRBMED Guidance for IRB Reviewers and Medical School Investigators Regarding Genetic/DNA Research Studies January 2015: This 2007 guidance is under revision. Certain passages may not reflect current IRBMED views and recommendations. The following is a list of issues that should be considered when reviewing protocols and informed consent documents...
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...
