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...

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...

eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.

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...

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 It is obsolete as of June 11, 2018.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...

This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...

Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...