Abstract
The ethical basis for clinical trials grew out of the responses to historical lessons in transgressions against vulnerable populations. Resnik proposed four principles for biomedical research: truth telling or veracity, dialogue or free exchange, caution or prudence, and social responsibility or civic duty. Emanuel et al. subsequently defined seven ethical requirements for clinical research relating to social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects. A key concern with procedural clinical trials relates to those with “sham surgery” arms, and several ethical considerations must to be taken into account when designing research with evaluating for placebo effect.
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