Whether a QI project requires informed consent (written or oral) is a function of the risk-benefit analysis of the study such a determination should not be at the sole discretion of the investigators, but should come from an appropriately constituted review board with expertise in the ethics of biomedical research. I am only up to page 50 of 436, as I write this. If one is faced with benefitting oneself or helping those around him or her, the best choice is to go to the aid of others, not only because you have a moral. The ethics of quality improvement studies: do the needs of the many outweigh the needs of the few?Ĭlinical research involving human subjects and quality improvement (QI) projects share a common goal of seeking to improve human health, whether by directly changing the standard of care (research) or by improving the process(es) by which that care is delivered (QI).
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