Section for Translational Medical Ethics, Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.
Section for Translational Medical Ethics, National Center for Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg, Germany.
J Med Internet Res. 2021 Jun 8;23(6):e26631. doi: 10.2196/26631.
The secondary use of clinical data in data-gathering, non-interventional research or learning activities (SeConts) has great potential for scientific progress and health care improvement. At the same time, it poses relevant risks for the privacy and informational self-determination of patients whose data are used.
Since the current literature lacks a tailored framework for risk assessment in SeConts as well as a clarification of the concept and practical scope of SeConts, we aim to fill this gap.
In this study, we analyze each element of the concept of SeConts to provide a synthetic definition, investigate the practical relevance and scope of SeConts through a literature review, and operationalize the widespread definition of risk (as a harmful event of a certain magnitude that occurs with a certain probability) to conduct a tailored analysis of privacy risk factors typically implied in SeConts.
We offer a conceptual clarification and definition of SeConts and provide a list of types of research and learning activities that can be subsumed under the definition of SeConts. We also offer a proposal for the classification of SeConts types into the categories non-interventional (observational) clinical research, quality control and improvement, or public health research. In addition, we provide a list of risk factors that determine the probability or magnitude of harm implied in SeConts. The risk factors provide a framework for assessing the privacy-related risks for patients implied in SeConts. We illustrate the use of risk assessment by applying it to a concrete example.
In the future, research ethics committees and data use and access committees will be able to rely on and apply the framework offered here when reviewing projects of secondary use of clinical data for learning and research purposes.
临床数据在数据收集、非干预性研究或学习活动（二次使用）中的二次使用对于科学进步和医疗保健改善具有巨大潜力。与此同时，这也给数据被使用的患者的隐私和信息自主带来了相关风险。
由于当前文献缺乏针对二次使用中的风险评估的定制框架，也缺乏对二次使用的概念和实际范围的澄清，我们旨在填补这一空白。
在这项研究中，我们分析了二次使用概念的每个要素，提供了一个综合定义，通过文献回顾调查了二次使用的实际相关性和范围，并将广泛定义的风险（作为一定概率发生的一定程度的有害事件）进行操作化，以对二次使用中通常隐含的隐私风险因素进行定制分析。
我们提供了对二次使用的概念澄清和定义，并提供了可归入二次使用定义的研究和学习活动类型的列表。我们还提出了将二次使用类型分类为非干预性（观察性）临床研究、质量控制和改进或公共卫生研究的建议。此外，我们提供了一组决定二次使用中隐含的伤害概率或程度的风险因素。这些风险因素为评估二次使用中患者的隐私相关风险提供了一个框架。我们通过将其应用于一个具体示例来说明风险评估的使用。
未来，研究伦理委员会和数据使用和访问委员会将能够在审查用于学习和研究目的的临床数据二次使用项目时依赖和应用这里提供的框架。
