ABSTRACT
Modern concepts of the ethics and regulation of clinical research began after World War II when the Nazi physicians' atrocities became known to the world. The ten principles now known as the Nuremberg Code were written by the judges who presided over the war crimes trials of the Nazi physicians. In 1964, the World Medical Association published the Declaration of Helsinki, which emphasized, among other things, that clinical research should be conducted only by medically qualified persons and that clinical research on human beings cannot be undertaken without their free and informed consent. The Commission identified three fundamental ethical principles as relevant to the ethics of research involving human subjects: respect for persons, beneficence, and distributive justice. The purpose of ethical norms is to indicate how the requirements of the three fundamental principles may be met in the conduct of research involving human subjects.
