Human Participant Protection in CDC Research

All research involving human participants that is conducted or supported by CDC must comply with the HHS Policy for Protection of Human Research Subjects (45 CFR part 46). This includes research conducted by CDC employees or supported by CDC through funding or provision of other tangible support, whether conducted inside or outside the United States. Unless exempt, all such research must be approved by an institutional review board (IRB) prior to the start of the research. HRPO facilitates the work of the IRB and provides assistance and training for CDC staff engaged in research involving human participants. Clinical investigations that involve the use of drugs, biologics, or devices—whether unlicensed or used outside standard medical practice—are subject to IRB review and approval under 21 CFR Part 50 and 21 CFR Part 56.