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Templates
May 4, 2018

Data Office Data Request Form

To request data, complete a Data Request Form, which includes IRB information (if applicable), study team information and where you will store your data. Note: You may save your work and submit at a later time
Tags: Data Use
Templates
Mar 13, 2018

Data Office Data Set Specification

To request data, complete a Data Set Specification to define your subject population (inclusion/ exclusion criteria) and the data elements needed in your data set. Note: You may save your work and submit at a later time
Tags: Data Use
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
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
Policies
Jun 15, 2017

Establishment of New Biospecimen Collections Policy

This policy operates subject to the University of Michigan Medical School ( UMMS ) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition Within All UMMS Research Biorepositories (“UMMS Tissue Ownership Policy”) and applies to...
Tags: Data Use Biorepository Use
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
Policies
Mar 19, 2018

Consent and HIPAA Privacy Rule Authorization Policy

This policy aims to ensure that donor preferences are given due respect in the conduct of research projects that are facilitated by the Central Biorepository (CBR). It operates subject to the UMMS Policy Governing Tissue Sample Collection, Ownership...
Tags: Data Use Biorepository Use
Guidance
Aug 10, 2020

HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule governs the use and release of a patient's personal health information, also known as Protected Health Information (PHI) , by a covered entity . To use and/or disclose PHI...
Guidance
Aug 10, 2020

Limited Data Sets

Research on coded private information , or on non-identifiable information, is not regulated under the Common Rule . However, HIPAA Privacy Rule protections apply if a coded or non-identifiable data set contains Protected Health Information (PHI) in...
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
May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...
Informational
Dec 17, 2020

Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR

This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for secondary use of biospecimens. IRBMED may require more information from...
Guidance
Jul 8, 2020

Federal Exemption Categories

Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [ 45 CFR 46.104 ]. See also OHRP's Human Subject Regulations Decision Charts: 2018 Requirements The federal...
Guidance
Feb 26, 2021

Elements and Uses of a Repository

A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...
Policies
Mar 2, 2022

Statement of Practice: HIPAA and U-M study team members outside Michigan Medicine in eResearch applications

Consult guidance from Michigan Medicine Corporate Compliance Office (level-2 login or VPN required) and IRBMED for general definitions (PHI, HIPAA, Covered Entity, etc.) and concepts. The vast majority of studies subject to IRBMED oversight involve...
Tags: Study Coordinator Principal Investigator Study Teams IRBMED Statement of Practice
Guidance
Feb 16, 2022

Research Involving Genetic, Genomic, and/or DNA Collection or Analysis

This guidance document outlines IRB expectations for research involving genetic analysis which generates or uses human genetic information through analysis of human biospecimens and/or data. For this guidance, the relevant human genetic information...
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
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
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
Mar 2, 2022

Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments

Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance, limited English proficiency (LEP): insufficient understanding of English; Illiteracy or low literacy: a reading...

Office of Research
University of Michigan Medical School
1301 Catherine Street SPC 5624
Ann Arbor, MI 48109

North Campus Research Complex (NCRC)
2800 Plymouth Road Building 520, 3rd Floor
Ann Arbor, MI 48109-2800

Phone: 734-615-1332
Fax: 734-615-9458
Email: ummsresearch@umich.edu

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