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...

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...

This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M is a coordinating center is not the single IRB (sIRB)/IRB of record/reviewing IRB for sites other than U-M...

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted a two-year approval may not be used to support proposals or future awards involving federal funding. Click here...

The forms below are designed for use with various IRBMED submissions.

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...

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...