Department of Philosophy and Bioethics, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland.
Institute of Philosophy, Vilnius University, Lithuania.
Bioethics. 2019 Jun;33(5):617-624. doi: 10.1111/bioe.12571. Epub 2019 Mar 18.
In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health-care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health-care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy-making levels.
在本文中，我们试图回答学习型医疗保健系统（LHS）的伦理和概念框架（ECF）如何影响研究伦理中的一些主要争议的问题，为此我们解决了研究伦理的五个关键问题：（a）实践和研究之间有什么区别？（b）研究伦理与临床伦理之间的关系是什么？（c）临床均衡原则的伦理相关性是什么？（d）参与研究是否需要比医学实践更高的知情同意标准？以及（e）在医学中应该优先考虑什么伦理原则？这些问题使我们能够在研究和实践之间的区别上构建两个相反的理想化立场：研究和实践的整合模型和隔离模型。然后，我们将 LHS 的 ECF 与这两种理想化立场进行比较。我们认为，LHS 的 ECF 并没有解决这些问题，而是在研究伦理和临床伦理之间处于第三种、独立的立场。此外，我们认为，LHS 的 ECF 提出了新的伦理问题，需要进行额外的伦理分析和论证。我们的文章为研究伦理和临床伦理之间的关系的讨论做出了贡献，揭示了尽管学习型医疗保健系统可能会极大地改变医疗保健的格局，但一些伦理困境仍需要在理论和决策层面上加以解决。
