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.
Policies
Jun 15, 2017

Institutional Review Board Oversight Policy

This policy is to ensure that Central Biorepository (“CBR”) operations, and research projects facilitated by the CBR, undergo appropriate ethics committee review to protect human research subjects.
Guidance
Jun 5, 2017

Telephonic Consent - ARCHIVED

12/15/2021: This page has been archived. See Electronic Informed Consent and Waivers under OHRP, FDA and HIPAA pages for up-to-date information on similar topics. In most cases, a potential research subject (or subject's representative) must be...
Policies
May 26, 2017

Statement of Practice: Sections 15 and 16 of IRB Application

Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...
Policies
Apr 21, 2017

Indirect Cost Waiver

This policy addresses requests for reduced overhead recovery through the Indirect Cost Waiver mechanism.
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

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...
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...
Guidance
Jul 14, 2016

Resources - ARCHIVED

07/12/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant internal and external resource websites. The lists below provide direct links to resources both within the University of Michigan and outside the...
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...

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