Abstract

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: research participants are protected and benefited according to the highest ethical standards, while, on the other hand, researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.