Federal Regulations

The University policy on activities involving human subjects is to fully comply with the regulations of the Office for Human Research Protections (OHRP) and to implement the principles outlined in the Belmont Report.

Clayton State University has a signed compliance agreement with OHRP, a subdivision of the Department of Health and Human Services. The assurance document provides written assurance that all federally-funded research conducted at this institution which involves human subjects will be in compliance with the Code of Federal Regulations (CFR) Title 45, Part 46. These regulations have been adopted by Clayton State University to cover all research activities involving human subjects.

Federalwide Assurance Number: FWA00011633

Department of Health & Human Services Registration Number: IRB000059605030

Code of Federal Regulations

45 CFR Part 46 - Public Welfare: Protection of Human Subjects

• Subpart A: Federal Policy for the Protection of Human Subjects
• Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research
• Subpart C: Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research

21 CFR Part 50 - Protection of Human Subjects

21 CFR Part 56 - Institutional Review Boards