Sponsors Information

It is the responsibility of the sponsor to follow their institution's guidelines and abide by federal, state and local laws. When filing IND or IDE, please submit FDA approval letter to IRBco. It is the sponsors' responsibility to determine the needs of data safety using data safety monitoring boards, data monitoring committees or safety monitoring committees. Sponsors are expected to submit findings of the data safety monitoring boards or committees to IRBco, especially if it may affect research subjects' safety.

Sponsors are expected to maintain safeguards to maintain research subjects’ privacy and confidentiality as outlined in HIPAA (http://www.hhs.gov/ocr/hipaa/).


IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

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