Privacy and confidentiality in pragmatic clinical trials
Privacy and confidentiality in pragmatic clinical trials
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DOI：
10.1177/1740774515597677
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发表时间：
2015-10-01
期刊：
影响因子：
2.7
通讯作者：
Rubel, Alan
中科院分区：
文献类型：
--
作者：
McGraw, Deven;Greene, Sarah M.;Rubel, Alan
通过务实的临床试验，有机会回答有关治疗干预的相对风险、负担和益处的重要问题。然而，对保护这些信息隐私的担忧是重大的，并且必须与从常规临床实践中收集的数据中学习的必要性相平衡。对可识别信息的研究使用的传统隐私保护不成比例地依赖于知情同意或授权，其基础是这样的假设：这是履行尊重个人的道德原则所必需的。但知情同意的理想在实施过程中常常无法实现。此外，尊重个人的原则（包括他们在健康信息隐私方面的利益）可以通过其他机制得到遵守。数据匿名化在保护隐私方面也发挥着作用，但并不适合所有研究，特别是实用的临床试验。在本文中，我们探讨了旨在保护实用临床试验中隐私的伦理基础和监管框架。然后，我们回顾了尊重研究人员的新方法的例子，这些方法可能具有尊重患者隐私考虑的额外好处。
With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for personswhich encompasses their interests in health information privacycan be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.