Does Quorum Have a Compliance Statement?
Quorum Review IRB (Quorum) is registered with the United States Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). Quorum’s registration number for both is IRB 00003226. Quorum is also fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in the U.S. and Canada. Verification of AAHRPP accreditation is available on the AAHRPP website located at http://www.aahrpp.org.
Quorum conducts review in accordance with pertinent authorities, including, but not limited to, the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (E6), FDA regulations (21 CFR Parts 50 and 56), DHHS regulations (45 CFR Part 46), the Canadian Food and Drug regulations (Part C, Division 5), the Canadian Natural Health Products regulations (Part 4), the Tri-Council Policy Statement (TCPS 2), the ethical principles outlined in the Belmont Report, and the principles of the World Medical Association Declaration of Helsinki.
Quorum is appropriately constituted, organized, and operated in accordance with the regulations and guidelines referenced above, to the extent they apply, and Quorum’s applicable electronic records and signatures are compliant with FDA 21 CFR Part 11. Quorum also complies with other national, state, provincial, and local laws, and other relevant authorities, as they relate to research in which Quorum provides IRB oversight.