Compliance Statement and FDA/OHRP Registration
Sabai IRB Services has two IRBs registered with the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA).
Castle IRB: IRB Organization #: IORG0010151, and IRB Registration #: IRB00012054
Alpha IRB: IRB Organization #: IORG0005158, and IRB Registration #: IRB00006205
Compliance Statement
Sabai IRB Services operates in compliance with applicable laws and regulations including, but not limited to, federal regulations at 45 CFR 46 and 21 CFR Parts 50 and 56, as well as other pertinent guidelines, such as the NIH Guidelines and the International Conference on Harmonisation (ICH) E6 – Good Clinical Practice, as applicable.
As we strive to provide the highest quality in IRB review services, Sabai IRB Services performs internal quality assurance reviews of its activities on a semiannual basis and routinely undergo third party audits. Our IRBs have Full Accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.), the gold standard for quality in research protections.
Visit the AAHRPP page for more information at https://www.aahrpp.org. Questions or concerns may be directed to the Senior IRB Director at 888-442-2472 extension 2 or [email protected]
Melissa Fink, MA, CIP
Senior Director of IRB Services – Sabai IRB Services
