Hospital Universitario Central de Asturias, Universidad de Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain.
CEI OSI Araba, Universidad del País Vasco, Servicio de Nefrología, Hospital Universitario Araba, Vitoria, Vizcaya, Spain.
An Pediatr (Engl Ed). 2023 Sep;99(3):195-202. doi: 10.1016/j.anpede.2023.06.016. Epub 2023 Aug 17.
Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity.
任何在人类或人类生物样本上进行的研究都需要事先进行伦理评估，以避免所有相关方的风险和问题。这方面的立法非常广泛，强调保护患者权利，同时遵守自主、善行和公正的普遍原则。本文回顾了适用于临床试验、药物观察性研究、生物库项目或任何可能在医疗保健领域进行的其他类型研究的规定。它还讨论了研究伦理委员会、数据保护和科学诚信基础的作用。
