Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure Guidance for Institutional Review Boards and Clinical Investigators November 1998

GUIDANCE DOCUMENT

• Docket Number: FDA-1997-N-0257
• Issued by: Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

The FDA regulations for protection of human subjects can be found under part 50 (21 CFR part 50), and the regulations for the IRB’s can be found under part 56 (21 CFR part 56). The regulations require, with limited exceptions, obtaining and documenting legally effective informed consent for all human subjects of research on FDA regulated products and review of research involving human subjects by an IRB.

Section 56.110 provides for expedited IRB review procedures for certain categories of research involving no more than minimal risk, and for minor changes in previously approved research during the period for which approval is authorized.

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