IRB Handbook

As a Catholic institution of higher learning, The College of Saint Scholastica (CSS) recognizes the need for research activities that involve human beings serving as participants. At the same time, The College of Saint Scholastica is especially aware of its obligation to protect the rights of those individuals who participate in human subject research studies. Consequently, CSS has established and empowered an Institutional Review Board (IRB) to review all research investigations, externally funded or not, conducted by its students, faculty, staff, and administration involving human beings as research subjects. CSS, through its IRB, meets its responsibility for ensuring that the safety, welfare, and rights of all subjects are adequately protected. The interpretation and implementation of these policies and procedures is the responsibility of the CSS IRB.

Categories (10)

I. Statement of Principles and Policies

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II. Institutional Review Board Operating Procedures

IRBs must comply with HHS and FDA regulations in 45 CFR part 46 and 21 CFR parts 50 and 56,
respectively, when reviewing research subject to those regulations. Both the HHS regulations at 45 CFR
§46.103(b)(4) and (5) and the FDA regulations at 21 CFR §56.108(a) and (b) state that IRBs must follow
written procedures to ensure that the IRB’s operations meet the applicable regulatory requirements.
Developing meaningful content for written procedures involves a comprehensive and critical assessment
of the IRB’s responsibilities, functions, and operations, and the institution’s organizational structure.
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III. Scope of Research Activities Subject to IRB Review

All 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 policies and procedures for the protection of human research subjects. All CSS faculty and students who are PIs conducting human subjects research must submit an application to the CSS IRB and receive approval before collecting or analyzing data for the project. Consistent with OHRP recommendations, the IRB reserves the authority to determine whether a study qualifies as human subject research and whether human subject research is exempt from IRB review.

The IRB utilizes the definitions listed in the revised Common Rule (45 CFR §46.102) to determine whether a proposed study meets the criteria for human subject research.
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IV. Application Review and Approval

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V. Responsibilities of Investigators

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VI. Appeal Procedures

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VII. Non-Compliance

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VIII. Suspension or Termination of IRB Approval

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IX. Investigational Medical Devices

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X. International Research

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Articles (2)

Pinned Article Preface

Additional Resources