Medical School Office of Research

I'm Looking for Information About

Browse by:

De-identified Data Sets

NOTE : This page provides HIPAA -related guidance on “ de-identified data sets,”applicable only to data based on Protected Health Information (usually medical records). Other federal regulations enforced by the IRB have different standards and...

Guidance

Apr 17, 2019

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

Apr 9, 2019

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...

View All

Most Viewed

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.

Guidance

Feb 7, 2013

Humanitarian Use Device Requirements for U-M Physicians & Investigators

The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in...

Guidance

May 8, 2015

Decedents

Go to Medical School Office of Research Homepage

Recently Updated

De-identified Data Sets

Protected Health Information (PHI)

Elements and Uses of a Repository

Most Viewed

Assent Template

Humanitarian Use Device Requirements for U-M Physicians & Investigators

Decedents

Medical School Office of Research