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