The need for ensuring the protection of human subjects is a fundamental principle of human research, with its theoretical basis established by several key events following World War II. The atrocities of the Nazis during that war led, in 1947, to the Nuremberg Code, which outlined 10 principles of ethical research in humans (Figure 1).1 The Kefauver-Harris Act of 1962 amended the 1938 Food, Drug, and Cosmetic Act to include tighter federal regulations on the US drug industry. The birth defects induced by the antinausea and sedative drug thalidomide raised awareness of the inadequate preclinical and clinical testing of this drug prior to its widespread use, prompting the passage of this law requiring pharmaceutical companies to demonstrate safety and efficacy of a drug prior to marketing it. The Helsinki Declaration of 1964, and its subsequent revisions, set forth international ethical guidelines for biomedical research.2 Included in the Helsinki Declaration are statements that (1) research should be based on prior laboratory and animal studies; (2) research should be conducted by scientifically qualified persons; (3) research should be preceded by a careful risk-benefit analysis; (4) research should be conducted with the consent of the subject, legal guardian, or responsible family member; and (5) the “specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee.” Consent to remain in a research study should be obtained as soon as possible from the individual or a legally authorized representative. The Belmont Report of 19783 identified 3 overarching ethical principles to guide medical research: (1) respect for persons, who are entitled to autonomy and the right to give their informed consent prior to research participation; (2) beneficence, an obligation to maximize the benefits, and minimize the risks, of research participation; and (3) justice, which implies equal access to the potential beneficial effects of the research.