IRB Governance

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21 CFR § 56.101

Scope.

This provision defines the scope of FDA regulations regarding the composition, operation, and responsibilities of Institutional Review Boards for clinical investigations.

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21 CFR § 56.102

Definitions.

This provision provides the official definitions for terms used throughout the FDA regulations governing Institutional Review Boards and clinical investigations.

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21 CFR § 56.103

Circumstances in which IRB review is required.

This provision mandates that clinical investigations subject to FDA submission requirements must be reviewed and approved by an IRB.

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21 CFR § 56.104

Exemptions from IRB requirement.

The following categories of clinical investigations are exempt from the requirements of this part for IRB review:

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21 CFR § 56.105

Waiver of IRB requirement.

This provision allows the FDA to waive specific IRB requirements for research activities upon application by a sponsor or sponsor-investigator.

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21 CFR § 56.106

Registration.

Institutional Review Boards reviewing FDA-regulated clinical investigations must register with HHS and provide specific operational information.

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21 CFR § 56.107

IRB membership.

Institutional Review Boards must maintain a minimum of five members with diverse backgrounds and expertise to ensure adequate protection of human subjects.

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21 CFR § 56.108

IRB functions and operations.

In order to fulfill the requirements of these regulations, each IRB shall:

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21 CFR § 56.109

IRB review of research.

Institutional Review Boards are required to review, approve, or disapprove research activities and ensure informed consent processes are followed.

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21 CFR § 56.110

Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

IRBs may utilize expedited review procedures for research involving minimal risk or minor changes to previously approved research.

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21 CFR § 56.111

Criteria for IRB approval of research.

IRBs must determine that specific criteria regarding risk minimization, equitable subject selection, and informed consent are met before approving research.

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21 CFR § 56.112

Review by institution.

Institutional officials may conduct additional review of research approved by an IRB but cannot approve research that the IRB has not approved.

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21 CFR § 56.113

Suspension or termination of IRB approval of research.

IRBs have the authority to suspend or terminate research approval if the research is not conducted according to requirements or causes unexpected serious harm.

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21 CFR § 56.114

Cooperative research.

Institutions involved in multi-institutional studies may use joint review or reliance agreements to avoid duplication of effort.