Stockdale Jessica, Cassell Jackie, Ford Elizabeth
Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.
Department of Philosophy, School of History, Art History and Philosophy, University of Sussex, Brighton, UK.
Wellcome Open Res. 2019 Jan 17;3:6. doi: 10.12688/wellcomeopenres.13531.2. eCollection 2018.
: Use of patients' medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform ethical and privacy debates. : We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. : Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party's competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. : The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data.
在英国，将患者医疗数据用于健康研究、审计和服务规划等次要目的已得到充分确立。然而，治理环境以及公众对这项工作的理解却滞后了。我们旨在系统地回顾关于英国和爱尔兰公众对研究中使用患者数据的看法的文献，通过既定的生物医学伦理框架对这些看法进行批判性分析，以提炼出未来良好实践指南的潜在策略，并为伦理和隐私辩论提供参考。
我们使用患者、公众、意见和电子健康记录等术语搜索了三个数据库。如果实证研究对英国和爱尔兰的医疗保健使用者、患者或公众进行了调查，并考察了他们对将患者数据用于医学研究的态度、意见或信念，那么这些研究就符合纳入条件。结果通过框架分析被综合成广泛的主题。
在筛选的13492篇论文和报告中，有20篇论文或报告符合条件。虽然人们普遍愿意为了共同利益而分享患者数据用于研究，但这很少导致无条件的支持。公众对其隐私的潜在风险表达了两个普遍担忧。第一个担忧涉及一方保护数据安全的能力，而第二个担忧与一方使用数据的动机有关。
公众通过评估研究组织在数据处理方面的能力以及获取数据的动机来评估其可信度。围绕数据共享的公众态度体现了生物医学伦理中也被广泛接受的几个原则。这为理解公众态度提供了一个框架，在为监管机构和数据保管人制定任何指南时都应予以考虑。我们提出了四个突出问题，决策者在评估数据二次使用的提议时应加以解决。
