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Guidance
Mar 6, 2012

Accessing Medical Records

When requesting records the requestor must be listed on the approved IRB, provide the IRB# and approval letter. Medical record requests for research /review will be imaged and viewable in CareWeb . Health Information Management will generally image...
Templates
Mar 13, 2018

Data Office Access Request Form

Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at dataoffice@umich.edu .
Tags: Data Use
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
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...
Templates
Jul 9, 2018

CBR Use Proposal Form

Central Biorepository staff will use the information you provide in this form to make contact with the investigator(s) who collected the materials that might be useful to your project, begin to identify candidate samples, and assess and advise on...
Tags: Access
Templates
Dec 16, 2020

Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources

The CBR plans to provide certain materials (biospecimens and/or data associated with or derived from them) (“CBR resources”) from individuals who have participated as research subjects in the CBR (“CBR participants”), for use in the research project...
Tags: Access
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
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...
Policies
Feb 27, 2020

Privacy and Confidentiality Protections for Individual-Level Data Policy

This policy operates subject to all applicable laws, regulations, and U-M policies regarding protection of clinical and research data. It sets standards specific to Central Biorepository (CBR) operations in accordance with sound ethical principles...
Tags: Data Use Biorepository Use
Guidance
Aug 10, 2020

Uses & Disclosures of Protected Health Information (PHI)

Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...
Guidance
Aug 10, 2020

Protected Health Information (PHI)

Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...
Guidance
Aug 31, 2020

Certification Preparatory to Research

Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...
Guidance
Aug 10, 2020

Decedents

Research involving data and/or biospecimens from decedents (deceased i ndividuals) is not regulated under the Common Rule. However, if you or any member of the study team will be accessing Protected Health Information (PHI) of the decedent(s), the...
Guidance
Apr 17, 2012

Federal Regulations

Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 -- Institutional Review Boards 21 CFR 11 -- Electronic Records; Electronic Signatures 21 CFR 312 -- Investigational New Drug (IND)...
Policies
Jun 18, 2020

Use and Distribution of Biospecimens and Data Policy

This policy operates subject to the Medical School Governing UMMS Research Biorepositories Policy ("Research Biorepositories Policy") and applies to all Central Biorepository (CBR) resources. This policy establishes a framework for appropriate...
Tags: Data Use Biorepository Use
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
Aug 28, 2018

Statement of Practice: Version Control of Informed Consent Document(s)

To ensure that study teams are utilizing the most recently IRB-approved consent document at the time of amendment, IRBMED has standardized version control practices. Click here for PDF version.
Templates
Jul 8, 2020

Specialty Informed Consent Templates

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks , discomforts, inconveniences, and potential benefits involved if...
Guidance
Nov 21, 2012

Guidance for Blinded Studies

Informational
Dec 17, 2020

CBR Guidance for Secondary Distribution

This is not an exhaustive set of instructions on how you should complete your HUM application. This information only provides guidance on citing policies and practices related to CBR activities. You may have more information within each section...

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Email: ummsresearch@umich.edu

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