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Regulation of human subjects research has evolved in the wake of scandals involving mistreatment of human research subjects. In practice modern Institutional Review Boards (IRBs) are responsible for assuring that investigators are in compliance with the regulations regarding human subjects research. One of the principal obligations of IRBs is the determination of the level of risk posed to a participant and assuring that the risks are both acceptable and minimized by appropriate research design risk. A frequent complaint leveled against current IRBs is the tendency to review the scientific design of a research proposal. Early declarations regarding the ethical treatment of human research subjects include the Nuremberg Code, and the WMA Declaration of Helsinki. The description of the Tuskeegee Experiment was a watershed event in the history of US human research ethics, leading to the publication of the Belmont report elaborating the ethical principles in treatment of human subjects research.
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