Clinical 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). 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.

中文翻译：

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质量改进研究的伦理：多数人的需求是否超过少数人的需求？

涉及人类受试者和质量改进 (QI) 项目的临床研究有一个共同的目标，即寻求改善人类健康，无论是通过直接改变护理标准（研究）还是通过改进提供护理的过程 (QI) ）。QI 项目是否需要知情同意（书面或口头）取决于研究的风险收益分析；此类决定不应由研究人员自行决定，而应由组成适当且具有生物医学研究伦理专业知识的审查委员会做出。