Taking patient involvement seriously: a critical ethical analysis of participatory approaches in data-intensive medical research
Taking patient involvement seriously: a critical ethical analysis of participatory approaches in data-intensive medical research
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DOI：
10.1186/s12911-019-0799-7
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发表时间：
2019-04-25
影响因子：
3.5
通讯作者：
Schicktanz, Silke
中科院分区：
文献类型：
--
作者：
Beier, Katharina;Schweda, Mark;Schicktanz, Silke
医学和医疗保健领域的数据密集型研究，如健康相关的大数据研究（HBDR），意味着来自临床常规、研究和患者报告数据的数据，以及非医学的社会或人口统计数据，都被聚合和链接起来，以优化生物医学研究。在这种情况下，患者参与和参与的概念经常被用来合法化这种研究和改善其治理。这篇辩论论文的目的是批判性地研究参与性概念的具体用途和伦理作用的背景下，HBDR和数据密集型研究在医药healthcare.DiscussionWe介绍基本的概念区别的理解，通过在政治，生物伦理学和医学研究的相关领域的应用。在此背景下，我们确定了三个典型的参与角色，患者/受试者在HBDR领域内分配：参与者作为生物材料和数据的提供者，参与者作为自己的研究参与的管理者和参与者作为（共同）主要研究者。我们进一步说明了这些作用的示范性数据密集型的研究举措。我们对这些倡议及其各自的参与承诺的分析揭示了具体的道德和实际缺陷和挑战。影响，除其他外，道德和方法的研究标准，以及公众对研究的信任，从根本上的政治伦理层面的真正participation.ConclusionsBased上介绍的概念区别忽视的结果，我们制定的基本标准，合理的呼吁参与式的方法在HBDR和数据密集型研究在医学和医疗保健，以克服这些缺点。正如我们所建议的，这不仅是一个概念清晰的问题，而且是维持HBDR和相关医学研究的伦理标准和信任的关键要求。
BackgroundData-intensive research in medicine and healthcare such as health-related big data research (HBDR) implies that data from clinical routine, research and patient-reported data, but also non-medical social or demographic data, are aggregated and linked in order to optimize biomedical research. In this context, notions of patient participation and involvement are frequently invoked to legitimize this kind of research and improve its governance. The aim of this debate paper is to critically examine the specific use and ethical role of participatory concepts in the context of HBDR and data-intensive research in medicine and healthcare.DiscussionWe introduce basic conceptual distinctions for the understanding of participation by looking at relevant fields of application in politics, bioethics and medical research. Against this backdrop, we identify three paradigmatic participatory roles that patients/subjects are assigned within the field of HBDR: participants as providers of biomaterials and data, participants as administrators of their own research participation and participants as (co-)principal investigators. We further illustrate these roles by exemplary data-intensive research-initiatives. Our analysis of these initiatives and their respective participatory promises reveals specific ethical and practical shortcomings and challenges. Central problems affecting, amongst others, ethical and methodological research standards, as well as public trust in research, result from the negligence of essential political-ethical dimensions of genuine participation.ConclusionsBased on the conceptual distinctions introduced, we formulate basic criteria for justified appeals to participatory approaches in HBDR and data-intensive research in medicine and healthcare in order to overcome these shortcomings. As we suggest, this is not only a matter of conceptual clarity, but a crucial requirement for maintaining ethical standards and trust in HBDR and related medical research.