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All research proposals that intend to enroll human subjects must meet certain criteria before study related procedures can be initiated. Three core principles: respect for persons, beneficence and justice, as discussed in the Belmont Report are the basis of the criteria for IRB approval. All regulatory criteria must be met, and any applicable state or local laws apply. In addition, certain other criteria that are unique to The College of St. Scholastica may apply and must be met as well.

The Secretary of the Department of Health and Human Services and the Food and Drug Administration have established and published in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure (45 CFR §46.110). This policy describes the categories and IRB procedure for expedited review.

The purpose of this policy is to help clarify when student research falls under the purview of the CSS IRB and when it most probably does not. Classroom research assignments do not require IRB review beyond faculty supervision if the goal of the classroom research assignment is educational and not intended for generalizable knowledge.

It is the policy of this institution that when students are used as research participants, the researchers should carefully review and understand the concepts of coercion and undue influence.

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.

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 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.

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.

All The College of St. Scholastica (CSS) faculty, students, and staff involved in activities that fall under the federal definitions of Human Subjects Research are required to comply with federal and state laws as well as CSS IRB policies and procedures for the protection of human research subjects. This policy outlines the process to follow if an investigator is unsure if the research is human subjects research as defined by the regulations and CSS IRB policy.

Exempt research projects present risks so benign to the human subjects who participate in them, that the federal regulations, (45 CFR 46.104), say such projects are exempt from full Institutional Review Board (IRB) review. However, these categories of research are not exempt from expedited review by The College of St. Scholastica IRB. The purpose of this document is to describe research activities involving human subjects that meet exemption criteria under 45 CFR 46.104.