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
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...
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...
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...