The Independent Investigational Review Board, Inc. is an institutional review board
structured in compliance with the regulations of the Food and Drug Administration
contained in the Code of Federal Regulations (21 CFR 50 and 56), the Department
of Health and Human Services (45 CFR 46), and the Environmental Protection Agency
(40 CFR 26). In addition, the Independent IRB, Inc. is in compliance with the International
Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines for
IRB/IECs as applicable.
The IRB is duly constituted, has written procedures for initial and continuing review
(full and expedited) of clinical trials, prepares written minutes of convened meetings
and retains records pertaining to the review and approval process as required by
regulatory agencies and applicable laws. Independent Investigational Review Board,
Inc. is registered with FDA/OHRP. IORG0002954 represents the overall registration,
and IRB00003563 is the IRB registration number.
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