SOPs
Jul 14, 2020

IRBMED Standard Operating Procedures

The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM) . The IRBMED Standard Operating Procedures serve as a reference for investigators , IRBs,...
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
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
May 30, 2018

Blood Draw Guidelines

The whole blood volume is used as a general guide in estimating reasonable volumes of blood that can be removed safely. The table below shows values for mean blood volume in children , men and women (Geigy Scientific Tables, 7th Ed; 1971): Whole...
Guidance
May 7, 2018

Deception and Concealment

Deception in human subjects research means deliberately misleading subjects about the nature of a study. Concealment means deliberately withholding certain information. Studies involving deception or concealment must meet all criteria for a waiver...
Guidance
May 7, 2018

FDA Expanded Access Program at the University of Michigan

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...
Guidance
Jan 3, 2018

NIH Genomic Data Sharing Policy

All U-M IRBs ( IRBMED , IRB-HSBS , IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing. Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance...
Informational
Nov 22, 2017

Handling Patient Data General Security Guidelines

To minimize the risk of unauthorized disclosure of patient data and other sensitive information, data security must be a top priority for all. Research performed at the University of Michigan is governed by related institutional policies.
Guidance
Jun 5, 2017

Telephonic Consent

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol , including its risks , benefits , and alternatives. The subject's voluntary and un-coerced choice to participate must usually be...
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
Feb 17, 2017

Repository Overview

Data and biospecimen repositories (sometimes called registries, banks , or libraries) are used to store data, with or without biospecimens, for future research use. Federal regulations and U-M policies that protect the privacy of patients and...

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