Under what regulatory authorities does Quorum operate?
Quorum provides review services in accordance with the ICH Guidelines for Good Clinical Practice. For research to be conducted in the U.S., Quorum applies the requirements for institutional review boards found in the U.S. Food and Drug Administration regulations (21 CFR Part 56) and the U.S. Department of Health and Human Services regulations (21 CFR Parts 50 & 56). For research to be conducted within Canada, Quorum Review applies the requirements for research ethics boards found in the Canadian Food and Drug regulations (Part C, Division 5). Quorum conducts its review in accordance with the ethical principles outlined in the Belmont Report.