Clinical Trial Oversight

An Institutional Review Board/Independent Ethics Committee (IRB/IEC), also known as ethical review board, is a group formally designated to review and monitor biomedical and behavioral research involving human subjects.

In accordance with Food and Drug Administration (FDA) and Health and Human Services (HHS) regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

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