Clinical Investigators

Institutional Review Boards and
Protection of Human Subjects in Clinical Trials

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

• Guidance for Institutional Review Boards and Clinical Investigators.  A series of Information Sheets providing the Agency's current guidance on the protection of people who are subjects of research.  Topics include Institutional Review Boards and Sponsor-Investigator-IRB interrelationships, FDA clinical investigator inspections and sanctions, clinical trials protocols, informed consent, and documents necessary for the conduct of clinical trials.

• Information for Health Professionals.  Additional links to information on subject protection from FDA and other government agencies.

• Clinical Safety Data Management.   Provides the definitions and terminology associated with clinical safety experience and the standards for expedited reporting of adverse drug reactions that occur during clinical trials.

• FDA Compliance Program 7348.809 - BIMO for Institutional Review Boards

• FDA Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators.

• Institutional Review Board Questions: Phone 301-594-0020 or fax 301-594-1204.

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FDA/Center for Drug Evaluation and Research
Last Updated:  September 15, 2004
Originator: OTCOM/DML
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