BACKGROUND Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it'. MAIN BODY This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of 'how to obtain and ascertain valid consent to participation in health-related research' cannot always be fully answered by exclusive reference to pre-determined criteria/guidance provided by the guidelines and prior research'. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased. CONCLUSIONS Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be - general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines' nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts.

中文翻译：

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生物伦理反身性和有效同意的要求：概念工具。

背景 尽管存在关于如何获得对健康相关研究的有效同意的国际、区域和国家指南，但有效同意仍然是一个实际和规范的挑战。尽管通过在特定地点对同一主题的概念和实证研究获得了额外的循证指导，但这一挑战仍然存在。本文的目的是解释为什么尽管有此指导，这一挑战仍然存在，并提出有助于理解这一问题并最终缓解这一问题的概念资源。主体 本文认为，尽管存在关于如何获得有效同意的详细官方指南和先前的概念和实证研究，但“如何获得和确定参与健康相关研究的有效同意”的问题 不能总是通过仅参考指南和先前研究提供的预定标准/指导来完全回答。为了弄清楚为什么会这样以及如何缓解这一挑战，本文提出了六个概念。其中前五项旨在解决现有指南持续存在的不足之处。这些是事实怀疑主义；指南不足；概论; 上下文中立性和推定性。作为这五个的结果，本文分析并推荐了第六个，称为生物伦理反身性。生物伦理反身性被认为是一种方便的工具、技能和态度，除了特定背景研究的指导外，还可以进一步缓解持续存在的挑战。结论 关于如何获得对健康相关研究的有效同意的现有伦理准则应该是它们应该是什么——一般的、推定的和上下文中立的。这解释了它们在具体情况下应用时看似不足的地方。因此，如果我们了解指南的性质及其实施意味着什么，那么在获得有效同意时遇到的挑战就可以大大缓解。还需要培养反思性思维以及明智地缩小指南与其在具体案例中的应用之间不可避免的差距所需的相关技能。这同样适用于无法通过参考特定背景下先前概念和实证研究的额外指导来填补的空白。假定的和上下文中立的。这解释了它们在具体情况下应用时看似不足的地方。因此，如果我们了解指南的性质及其实施意味着什么，那么在获得有效同意时遇到的挑战就可以大大缓解。还需要培养反思性思维以及明智地缩小指南与其在具体案例中的应用之间不可避免的差距所需的相关技能。这同样适用于无法通过参考特定背景下先前概念和实证研究的额外指导来填补的空白。假定的和上下文中立的。这解释了它们在具体情况下应用时看似不足的地方。因此，如果我们了解指南的性质及其实施意味着什么，那么在获得有效同意时遇到的挑战就可以大大缓解。还需要培养反思性思维以及明智地缩小指南与其在具体案例中的应用之间不可避免的差距所需的相关技能。这同样适用于无法通过参考特定背景下先前概念和实证研究的额外指导来填补的空白。如果我们了解指南的性质及其实施的意义，则可以大大缓解在获得有效同意时遇到的挑战。还需要培养反思性思维以及明智地缩小指南与其在具体案例中的应用之间不可避免的差距所需的相关技能。这同样适用于无法通过参考特定背景下先前概念和实证研究的额外指导来填补的空白。如果我们了解指南的性质及其实施的意义，则可以大大缓解在获得有效同意时遇到的挑战。还需要培养反思性思维以及明智地缩小指南与其在具体案例中的应用之间不可避免的差距所需的相关技能。这同样适用于无法通过参考特定背景下先前概念和实证研究的额外指导来填补的空白。