Please describe the regulatory authorities under which Quorum operates.
Quorum Review IRB conducts review in accordance with pertinent authorities, including but not limited to, the ICH Guidelines for Good Clinical Practice, U.S. Food and Drug Administration (21 CFR Parts 50 and 56), U.S. Department of Health and Human Services (45 CFR Part 46), the ethical principles outlined in the Belmont Report, the Canadian Food and Drug Regulations (Part C, Division 5), Part 4 of the Canadian Natural Health Products Regulations, and the Tri-Council Policy Statement (TCPS 2).
Quorum Review IRB is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) with registration number IRB 00003226. Quorum Review IRB is also fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Verification of AAHRPP accreditation can be obtained on the AAHRPP website located at http://www.aahrpp.org.
As a research ethics board, Quorum Review IRB is appropriately constituted, organized, and operated in accordance with regulations and guidelines referenced above and the World Medical Association Declaration of Helsinki, to the extent they apply. Quorum Review IRB also complies with other national, state, provincial, and local laws such as the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA Privacy Rule”), the Personal Information Protection and Electronic Documents Act (PIPEDA), and other relevant authorities in jurisdictions that relate to clinical research in which Quorum Review IRB provides oversight.