Learning from Clinical Data: Ethical, Social and Legal Aspects

从临床数据中学习（LinCDat）项目旨在从经验、伦理和法律的角度调查，将医学数据用于研究和学习活动的模式从特殊用途转变为常规用途是否可取和可行，临床护理的数据可用于各种创新、数据收集、非介入性研究或学习活动（DaNIS），以产生超越个体患者诊断和治疗的有价值的见解。这些研究被认为是低风险的，利用DaNIS的临床数据可以通过推进科学和提高医疗质量来造福患者和社会。然而，存在严重的实际困难和规范问题，例如对患者隐私和数据主权的保护，这些问题必须得到解决。到目前为止，在像德国这样的公共卫生保健系统中，所有利益相关者为DaNIS做出贡献的权利和责任尚未得到深入探讨，并且缺乏在伦理和法律分析中包含利益相关者观点所需的经验数据。缺乏对与DaNIS相关的规范问题的严格调查已经产生了不安，阻碍了系统地提供和使用临床数据进行学习和研究。在我们的项目中，我们采用跨学科的方法来解决DaNIS提出的道德、法律和社会问题：第一步是开发DaNIS的类型学，并分析机会、风险和负担。（工作包1:WP1）。在WP1的基础上，我们调查了医生（WP2）和患者（WP3）对DaNIS的态度、道德和法律权利和义务。我们还研究了社会，特别是根据公共卫生保健系统，是否以及在多大程度上有权从患者、医生和机构那里获得DaNIS的贡献，以及公共机构保护利益相关者和促进DaNIS的责任。最后，我们利用WP1-4的见解，为1)政策制定者、2)资助机构和3)医疗保健机构开发DaNIS治理框架，解决以下问题：a)告知、参与和保护患者的原则和程序；b)医生的角色和医生参与DaNIS的激励机制c)患者、医生和机构参与DaNIS的角色和责任。治理框架旨在制定鼓励共享和使用临床数据的战略，同时保持严格但适当的信息治理和问责制。Winkler教授在大学医疗中心担任主治医师，这确保了他能够进入该领域，并随时有机会在临床实践中实施方法。作为墨卡托研究员的Adrian Thorogood将提供卫生和基因组数据的伦理和法律治理以及最佳做法方面的国际专业知识。

The project Learning from Clinical Data (LinCDat) aims to investigate if a paradigm shift from exceptional to routine use of medical data for research and learning activities would be desirable and feasible, from an empirical, ethical and legal view Data from clinical care can be used in various innovative, data-gathering, non-interventional studies or learning activities (DaNIS) to generate insights valuable beyond the diagnosis and treatment of the individual patient. These studies are thought to be low-risk, and utilizing clinical data for DaNIS can benefit patients and society through advancing science and improving health care quality. However, there are serious practical difficulties and normative concerns, such as protection of patients’ privacy and data sovereignty, which must be addressed. So far, rights and responsibilities of all stakeholders to contribute to DaNIS within a public health care system like Germany’s have not been explored in depth, and the empirical data needed to include the perspectives of stakeholders in an ethical and legal analysis are missing. The lack of a rigorous investigation of the normative issues related to DaNIS has engendered unease, hindering the systematic provision and use of clinical data for learning and research.In our project, we employ an interdisciplinary approach to address ethical, legal and social questions raised by DaNIS: the first step is to develop a typology of DaNIS and analyze the opportunities, risks and burdens. (Work Package 1: WP1). Building on WP1, we investigate the attitudes, and moral and legal rights and duties of physicians (WP2) and patients (WP3) concerning DaNIS. We also examine whether and to what extent society, particularly in light of public health care systems, is entitled to contributions to DaNIS from patients, physicians and institutions, as well as the responsibilities of public instituions to protect stakeholders and promote DaNIS. Finally, we leverage the insights from WP1-4 to develop a governance framework for DaNIS for 1) policy makers, 2) funding agencies, and 3) health care institutions addressing: a) principles and procedures to inform, involve and protect patients; b) the role of physicians and incentives for physicians to contribute to DaNIS c) patients’, physicians’, and institutions’ roles and responsibilities to contribute to DaNIS. The governance framework aims to develop strategies that encourage the sharing and use of clinical data while maintaining rigorous but proportionate information governance and accountability. Prof. Winkler’s position as attending physician in a university medical center ensures access to the field and readily available opportunities for implementing approaches in clinical practice. International expertise in the ethical and legal governance of health and genomic data and best practices will be provided by Adrian Thorogood as Mercator Fellow.