How do FDA regulations for protection of human subjects, 21 CFR Parts 50 and 56, differ from HHS regulations in 45 CFR Part 46 subpart A?
A general comparison appears in the FDA Information Sheets, Guidance for Institutional Review Boards and Clinical Investigators found at http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm. For additional information on 45 CFR Part 46 subpart A refer to the Office for Human Research Protections.
Related Questions
- Activities must meet the definition of research and involve human subjects as defined in DHHS regulations, or be research and involve human subjects as defined in FDA regulations to be subject to the IRBs jurisdiction. How do I know if my project meets the definition of human research?
- How do FDA regulations for protection of human subjects, 21 CFR Parts 50 and 56, differ from HHS regulations in 45 CFR Part 46 subpart A?
- How does 45 CFR part 46 relate to the human subjects regulations used by non-HHS federal funding agencies?
