Governing Laws, Regulations, and Principles

The Prisma Health OHRP is established pursuant to and in accordance with the laws, regulations, and principles listed below regarding the protection of human subjects. Prisma Health will adhere to these laws, regulations, and principles with regard to research conducted by or under its auspices:

• Prisma Health Statement of Compliance
• The Department of Health and Human Services (HHS) policy and regulations at 45 CFR Part 46, also known as the Federal Policy for the Protection of Human Subjects or the "Common Rule" (collectively referred to in this document as the "HHS Regulations");
• Food and Drug Administration (FDA) regulations at 21 CFR Parts 51 and 56 (collectively referred to in this document as the "FDA Regulations");
• The principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (collectively referred to in this document as the "Belmont Report");
• For projects conducted or supported by the DoD, any DoD requirements.
• All other applicable federal, state and local laws and regulations.