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.

Categories (9)

1. Purpose, Scope, and Authority

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2. IRB Membership

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3. Meetings

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4. Records

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5. Cooperative Research

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6. Conflict of Interest Policies and Procedures

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7. Training and Orientation

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8. Staffing and Other Support

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9. Organizational Placement and Reporting

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Articles (1)

Pinned Article Changes to Policies and Procedures

The policies and procedures in this manual will be revised, as needed, to accommodate changes to federal regulations and guidance concerning the protection of human subjects. Major revisions of the manual will be reviewed by the IRB Board at the first regularly scheduled convened meeting. In addition, the Vice President of Academic Affairs will be informed of the approved changes and provided a copy of the revised SOP and Manual. The CSS IRB website will be updated.