Guidance
May 7, 2018

Expedited Review

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS...
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...
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...
Guidance
Dec 13, 2016

Emergency Use of a Test Article in Life-Threatening Circumstances

This guidance describes the circumstances regarding Expanded Access Emergency Use ( Emergency Use ) of an investigational product (drug, biologic , or device) and the procedures to be followed before or immediately following the emergency use of an...
Guidance
Jul 14, 2016

Resources

The lists below provide direct links to resources both within the University of Michigan and outside the institution.
Guidance
Feb 19, 2016

International Research

In order for UM researchers to conduct a research project outside of the U.S., the foreign host hospital/research center must negotiate an International Assurance Agreement with the Office of International Activities (OIA) in the Office of Human...
Guidance
Nov 6, 2015

Certificates of Confidentiality

Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on...
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.

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