de Lecuona Itziar
Departamento de Medicina, Facultad de Medicina; Observatorio de Bioética y Derecho de la Universidad de Barcelona; Comité de Ética de la Investigación del Hospital Clínic de Barcelona, Barcelona, España.
Gac Sanit. 2018 Nov-Dec;32(6):576-578. doi: 10.1016/j.gaceta.2018.02.007. Epub 2018 May 31.
The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research.
当前用于审查涉及人类的研究的模式基本上依赖于研究伦理委员会内部的决策过程。这些委员会必须意识到基于大规模利用数据集（包括健康方面的个人数据）的新数字范式的重要性。本文结合欧盟的《通用数据保护条例》，为适当评估基于医疗保健中大数据分析使用的项目提供指导方针。收集和使用这些数据的过程构成了当前开展研究的一个特定领域。在这种背景下，现有的从参与者那里获得知情同意的方案已经过时，因为它们不仅基于个人数据已被匿名化的假设，而且还基于这些数据在未来将继续保持匿名的假设。因此，研究伦理委员会必须具备新的能力并重新审视隐私和自由等价值观，更新方案、方法和工作程序。工作文化的这种转变将为参与研究的人员提供法律保障，将有可能确保对数据主体隐私的保护，并将允许引导数据的利用，以避免在这个去识别化时代个人数据被商品化，从而使研究满足实际社会需求，而不是满足伪装成研究的虚假或投机利益。
