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Belmont Report

The National Commission developed the Belmont Report for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978. The Department of Health and Human Services has incorporated the following principles from this report into federal policy and the Food Drug Administration regulations embrace the principles in their regulations.

1. Respect for persons. The personal dignity and autonomy of individuals should always be recognized, with special protection of those persons with diminished autonomy. Autonomy is protected by allowing individuals to make informed decisions.

2. Beneficence. Research should maximize anticipated benefits and minimize possible risks of harm.

3. Justice. The benefits and burdens of research should be distributed fairly

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