The Belmont Report ( Back )

In 1979, after four years of work, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research:

1. Respect for persons: recognizing the autonomy and dignity of individuals, and the need to protect those with diminished autonomy (i.e. impaired decision-making skills), such as children, the aged, and the disabled;

2. Beneficence: an obligation to protect persons from harm by maximizing benefits and minimizing risks;

3. Justice: fair distribution of the benefits and burdens of research.

The report explains how these principles apply to research practices. In response to the report, both the Department of Health and Human Services and the Food and Drug Administration revised their regulations on research studies that involve people.