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医学伦理:对肾脏病学的意义。

Ethics in Research: Relevance for Nephrology.

机构信息

Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA.

Department of Anatomy, College of Health Sciences, Makerere University, Kampala, Uganda.

出版信息

Semin Nephrol. 2021 May;41(3):272-281. doi: 10.1016/j.semnephrol.2021.05.008.

Abstract

Research is crucial to progress in nephrology. It is important that studies are conducted rigorously from the scientific perspective, as well as in adherence to ethical standards. Traditional clinical research places a high value on individual research subject autonomy. Research questions often include the clinical effectiveness of new interventions studied under highly controlled conditions. Such research has brought the promise of new game-changers in nephrology, such as the sodium-glucose cotransporter 2 inhibitors. Implementation research takes such knowledge further and investigates how to translate it into broader-scale policy and practice, to achieve swift and global uptake, with a focus on justice and equity. Newer challenges arising globally in research ethics include those relating to oversight of innovation, biobanking and big data, human-challenge studies, and research during emergencies. This article details the history of clinical research ethics and the role of research ethics committees, describes the evolving spectrum of biomedical research in human medicine, and presents emerging clinical research ethics issues using illustrative examples and a hypothetical case study. It is imperative that researchers and research ethics committees are well versed in the ethical principles of all forms of human research such that research is conducted to the highest standards and that effective interventions can be implemented at scale as rapidly as possible.

摘要

研究对于肾脏病学的进展至关重要。从科学角度严格进行研究,并遵守伦理标准非常重要。传统的临床研究非常重视个体研究对象的自主权。研究问题通常包括在高度受控条件下研究新干预措施的临床效果。此类研究带来了肾脏病学中一些新的变革性进展的希望,例如钠-葡萄糖共转运蛋白 2 抑制剂。实施研究则更进一步,探讨如何将其转化为更广泛的政策和实践,以实现迅速和全球采用,并关注正义和平等。在全球范围内,新出现的研究伦理挑战包括与创新、生物库和大数据、人类挑战研究以及紧急情况下的研究相关的监督问题。本文详细介绍了临床研究伦理的历史以及研究伦理委员会的作用,描述了人类医学中不断发展的生物医学研究范围,并通过实例和假设案例研究介绍了新兴的临床研究伦理问题。研究人员和研究伦理委员会必须精通所有形式的人类研究的伦理原则,以便以最高标准进行研究,并尽快大规模实施有效的干预措施。

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