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This information is intended as guidance in making a preliminary determination regarding the need for IRB oversight. Whenever there is uncertainty as to whether a project is considered Research or QI, the investigator should request guidance from The College of St. Scholastica (CSS) IRB.

The CSS Institutional Review Board (IRB) functions independently. Attempts to coerce or otherwise unduly influence the actions of the IRB are forbidden by policy and are to be reported. Likewise, the CSS IRB must remain free from the influence of financial and other organizational interests. No individual with responsibility for the business and financial interests of the organization may serve on the IRB.

The College of St. Scholastica IRB prepares and maintains documentation of its activities as required by federal regulation and in accordance with the IRB’s record retention policy. Required documents must be submitted to the appropriate funding entity as required. This policy applies to all controlled documents used in research reviewed by the IRB.

Except when an expedited review procedure is used, the CSS IRB will review proposed research at convened meetings at which a quorum is present. The IRB will meet monthly or at some other frequency determined by the IRB Chair and the IRB Administrator. These policies and procedures apply to all research submitted to the CSS IRB.

The purpose of this policy is to describe the IRB charter, appointments, and administrative structure.

The purpose of this policy is to describe the agreement with the Department of Health and Human Services Office of Human Research Protection (OHRP) through the FWA.