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Minneapolis VA Health Care System Research Service

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Institutional Review Board (IRB)

The Minneapolis VAHCS Institutional Review Board (IRB) protects the rights and welfare of people (mainly Veterans) involved in research studies at our facility. The IRB reviews plans for research involving human subjects. Institutions that accept research funding from the federal government must have an IRB to review all research involving human subjects, even if a given research project does not involve federal funds. The Department of Veterans Affairs follows the Common Rule for the Protection of Human Subjects (the 2018 Requirements, encoded in 38 CFR Part 16). The specific responsibilites and requirements of the Minneapolis VAHCS IRB are defined under VHA Directive 1200.05 "Requirements for the Protection of Human Subjects in Research".

The IRB reviews all aspects of human subjects studies, including initial review applications, amendments, continuing reviews, and closures. The definition of research involving human subjects is broad, and includes research that involves medical record data, surveys, behavioral research, biomedical devices, and other clinical research. In addition, the IRB reviews all clinical investigations that support applications for research or marketing permits for products regulated by the FDA.

A note for investigators new to the VA: Some studies involving human subjects or data derived from human subjects are exempt from IRB oversight. At non-VA facilities these studies may not need any additional approvals. However, in VA research, IRB exempt studies fall under the purview of the RDC. If the IRB determines that your proposed study is exempt, you will still need to obtain approval from the RDC before initiating research activities.

The Minneapolis VAHCS IRB is a component of our facility Human Research Protection Program (HRPP), which includes administrative oversight of all apsects of human subjects research at our facility. This includes our local IRB, and management of communication with the VA Central IRB and with the various external commercial or central IRBs for which our facility maintains VA-approved reliance agreements. Our facility HRPP Director, Julie Toth, supervises our IRB administrative staff (Margaret Bordanea, Nicholas Halbert, and Alexandra Rex).

The Minneapolis VAHCS IRB holds a Federalwide Assurance, FWA 00001480, from the Office for Human Research Protection (OHRP) in the U.S. Department of Health and Human Services (HHS). For details on the IRB registration, please see the most recent Federalwide Assurance and IRB Registration letter for our site.

To submit a new IRB research protocol, or to modify an existing study, complete all necessary forms in IRBNet.

For assistance, contact the IRB by emailing IRBMN@va.gov.