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, Heidelberg, Germany.
J Med Internet Res. 2022 Aug 25;24(8):e37665. doi: 10.2196/37665.
BACKGROUND: Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients' willingness to support research with their clinical data is a crucial prerequisite for research progress. OBJECTIVE: The aim of the study was to learn about patients' attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS: A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. RESULTS: In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). CONCLUSIONS: Although patients' general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.
背景：将临床数据用于生物医学研究具有巨大潜力，可以支持各种非干预性、数据驱动的研究。患者是否愿意支持其临床数据的研究，这是研究进展的关键前提。
目的：本研究旨在了解患者对二次使用其临床数据的态度和期望。下一步，我们的研究结果可以为制定适当的临床数据二次使用治理框架提供依据，以支持研究。
方法：开发了一份问卷，以评估癌症患者是否愿意为生物医学研究目的提供其临床数据，同时考虑不同的数据共享条件和同意模式。德国巴登-符腾堡州癌症登记处基于全面普查，按比例分层随机招募癌症患者和癌症幸存者作为研究对象。
结果：共有 838 名参与者完成了调查。大约所有参与者（810/838，96.7%）表示愿意将临床数据用于生物医学研究目的；然而，他们期望满足某些要求，例如在国外使用数据时应采用可比的数据保护标准，以及定期重新获得同意的可能性。大多数参与者（620/838，73.9%）支持商业公司的研究人员使用数据。超过一半的参与者（503/838，60%）愿意放弃对临床数据的控制，以换取研究利益。大多数参与者接受广泛同意模式（494/838，58.9%），其次是默认数据使用模式（随时可以选择退出；419/838，50%）；最低接受率的是特定研究的特定同意模式（327/838，39%）。患者期望医生分享他们的数据（763/838，91.1%），并期望他们的病友支持用他们的临床数据进行二次使用（679/838，81%）。
结论：尽管患者普遍愿意将其临床数据用于生物医学研究目的，但相当一部分患者的意愿取决于额外的要求。考虑到这些观点，对于设计值得信赖的临床数据再利用和共享治理至关重要。特别需要考虑接受对临床数据控制的丧失，以增强研究利益。
J Med Internet Res. 2021-10-1
J Med Internet Res. 2010-5-25
JAMA Netw Open. 2019-8-2
JMIR Public Health Surveill. 2023-3-23
Arch Public Health. 2025-2-18
J Med Internet Res. 2025-1-20
J Med Internet Res. 2024-12-17
J Family Med Prim Care. 2024-9
JMIR Med Inform. 2024-6-18
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2024-6
BMC Med Ethics. 2021-12-15
J Med Internet Res. 2021-10-1
BMC Med Ethics. 2021-8-10
Zotero 插件
