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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 help with IRBNet, staff with VA network access can review the information on the VA Innovation and Research Review System (VAIRRS) University SharePoint at https://dvagov.sharepoint.com/sites/VHAORPPE/VAIRRS/SitePages/VAIRRS-University.aspx (copy and paste this link into your browser). All staff can also email our local support team at VHAMINIRBNet@va.gov.

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


HRPP Standard Operating Procedures

HRPP 10-001 ISSO and PO Review of Human Studies Research

HRPP 10-002 Expired Suspended Terminated IRB Approval

HRPP 10-004 Serious Adverse Event, Serious Problem and Unanticipated Problem Reporting

HRPP 10-006 IRB Exempt studies

HRPP 10-005 Informed Consent and HIPAA Authorization 2023-08

HRPP 10-010 All of Us IRB SOP Minneapolis

HRPP 10-011 NCI CIRB SOP Minneapolis

HRPP 10-012 VA CIRB as IRB of Record

HRPP 10-013 Expedited IRB review

HRPP 10-014 Converting a study to 2018 Requirements (Revised Common Rule)

HRPP 10-030 Advarra as IRB of Record for Minneapolis VA Health Care System

HRPP 10-031 WIRB as IRB of Record for Minneapolis VA Health Care System

HRPP 10-IT-003 Clinical Monitors