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...

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...

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 .

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...

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 (...

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...

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...

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...

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...