What is the relationship between the Belmont Report and the Common Rule?

The Belmont Report outlines ethical principles that serve as the foundational guidelines for the protections of human subjects in research and informs the regulations established in the Common Rule. Published in 1979, the Belmont Report identifies three core ethical principles: respect for persons, beneficence, and justice. These principles are essential in guiding the ethical conduct of research involving human subjects.

The Common Rule, formally known as 45 CFR 46, is a set of federal regulations that provide specific requirements for ethically conducting research, including the necessity of Institutional Review Boards (IRBs) and informed consent processes. While the Common Rule articulates these regulations in legal terms, it is grounded in the ethical framework provided by the Belmont Report. Therefore, understanding the ethical principles outlined in the Belmont Report is crucial for interpreting and implementing the requirements of the Common Rule. This connection highlights the importance of ethical considerations in the regulatory landscape of human subjects research.