Templates
Mar 29, 2017

FDA Expanded Access Informed Consent Template

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...
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...
Policies
Dec 9, 2016

Institutional Cost Sharing

This policy describes the process and conditions for obtaining a research cost share commitment from the Medical School Dean’s Office, Hospital and Health Center, or EVPMA . It also addresses the process for Medical School units seeking a cost share...
Policies
Dec 9, 2016

Recovering Full Indirect Costs: Industry Funded Research

This policy details the required process that should be used to negotiate the indirect cost rate with industry sponsors . The Medical School does not support indirect cost waivers on industry funded research. Please visit the Indirect Cost Waiver...
Policies
Dec 9, 2016

Indirect Cost Waivers on Federal Patient Pass-Through Costs

This policy describes the process and conditions for Medical School units seeking a reduction of indirect costs on pass-through expenses related to clinical trial patient payments on federal projects. Please review the School’s companion policy on...
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.
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...
Templates
Jan 13, 2014

Assent Template

(Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.

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