Which document is considered the cornerstone for ethical principles in human subjects research?

The Belmont Report serves as a foundational document that articulates the ethical principles and guidelines for research involving human subjects, pivotal for the framework of ethical conduct in biomedical and behavioral research. It outlines three core ethical principles: respect for persons, beneficence, and justice. Respect for persons emphasizes informed consent and the autonomy of individuals participating in research. Beneficence highlights the importance of maximizing benefits and minimizing harm to research subjects. Lastly, justice focuses on the equitable distribution of research burdens and benefits, ensuring that no particular group of people is unfairly burdened or excluded from the potential benefits of research.

While other documents, such as the Declaration of Helsinki, the Nuremberg Code, and the Common Rule, contribute significantly to the ethics of human subjects research, the Belmont Report is particularly notable for its comprehensive articulation of these principles and serves as a guiding framework particularly in the context of U.S. federal regulations. Its influence extends through various institutional policies and IRB practices, solidifying its role as the cornerstone of ethical principles in this field.