Pragmatic Health Ethics Research Unit, Institut de recherches cliniques de Montréal (IRCM), Montréal, QC, Canada.
Université de Montréal, Montréal, QC, Canada.
Bioethics. 2019 Jan;33(1):19-34. doi: 10.1111/bioe.12471. Epub 2018 Aug 23.
The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under-theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed-upon strategy is to move from categorical towards analytical approaches (focused on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment-resistant depression, we illustrate how the integrative-functional account can guide the analysis of vulnerability in research within a pragmatist, evidence-based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative-functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance.
脆弱性的概念在研究伦理中被广泛应用，以引起对研究中需要特殊保护的参与者的关注。然而，这个概念是模糊的，没有得到充分的理论化。人们越来越担心，脆弱性的主导分类方法（例如，研究伦理法规和准则划定脆弱群体）在伦理上存在问题，因为它对人群的假设，实际上并没有很好的指导作用。人们达成了一项共识，即从分类方法转向分析方法（侧重于分析脆弱性的类型和来源）。然而，除了这一共识之外，学者们一直在提出关于脆弱性的相互竞争的观点，但在研究伦理中对其适当的操作化并没有达成一致意见。基于之前的争论，我们提出，研究伦理中全面的脆弱性概念必须包括四个组成部分：定义、规范理由、应用和影响。我们得出结论，没有现有的观点以功能（即实际适用）的方式整合这些组成部分，并提出了一个受实用主义理论启发并由生物伦理学文献丰富的脆弱性综合功能观点。我们用治疗抵抗性抑郁症的深部脑刺激研究为例，说明了综合功能观点如何在实用主义、基于证据的研究伦理方法中指导研究中脆弱性的分析。虽然现有脆弱性研究伦理指南中仍存在需要解决的问题，但综合功能观点可以作为一种分析工具，帮助研究人员、研究伦理委员会和其他相关行为者填补当前研究伦理治理领域的空白。
