Institutional Review Boards

Scope.

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

Definitions.

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

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.

Exemptions from IRB requirement.

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

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.

Registration.

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

IRB membership.

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

IRB functions and operations.

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

IRB review of research.

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

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.

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.

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.

Suspension or termination of IRB approval of research.

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

Cooperative research.

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

IRB records.

Institutions or IRBs must maintain detailed documentation of research proposals, meeting minutes, correspondence, and member information for at least three years after research completion.

Lesser administrative actions.

The FDA may issue notices of noncompliance to IRBs and institutions, requiring corrective action plans and potentially restricting or terminating ongoing research studies.

Disqualification of an IRB or an institution.

The FDA Commissioner may disqualify an IRB or institution for repeated noncompliance that adversely affects the rights or welfare of human subjects in clinical investigations.

Public disclosure of information regarding revocation.

FDA disqualification determinations and associated administrative records regarding an institution are subject to public disclosure.

Reinstatement of an IRB or an institution.

Disqualified IRBs or institutions may be reinstated upon submitting a corrective action plan that provides adequate assurance of future compliance.

Actions alternative or additional to disqualification.

FDA disqualification is independent of other civil or criminal proceedings, and the agency may refer matters to other government entities for appropriate action.