The overriding ethical principle in human research is that the rights of individual subjects should take precedence over the expected benefits to human knowledge or the community. This principle does not preclude research that may lead to harm to subjects, provided that the subjects accept voluntarily and with complete information. Ensuring ethical practice in epidemiological research includes working only from written research protocols that specifically address ethical issues, ensuring that research protocols have been passed by an ethical review committee, and obtaining informed consent from subjects except where the research is judged to present no more than minimal risk. It also includes accessing personally identifiable data without the subjects' consent only under carefully defined conditions, making adequate provision for the confidentiality of personally identifiable data, and ensuring that results obtained during the course of research that may have a bearing on the welfare of subjects are communicated to them.
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