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Post-trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation

机译：2013年赫尔辛基宣言中的审后义务：分类，重建和解释

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The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of Post-trial provisions' is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous fair benefit' language. However, I criticize the disappearance of access to other appropriate care' present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research.
机译：本文的总体目的是对《 2013年赫尔辛基宣言》中各个研究参与者的审后义务做出批判性解释。当研究结束时，将研究参与者转变为适当的医疗保健是一个全球性问题。出版新版本的《赫尔辛基宣言》是一个很好的机会来讨论它。我认为，《 2013年赫尔辛基宣言》确定了至少两种明显不同的审后义务类型，特别是研究后获得护理和研究后获得信息。有权获得审判后访问权的代理人是研究的个人参与者。该宣言确定了赞助者，研究者和东道国政府为负责遵守上述审判后义务的主要代理人。为了证明对审后义务的这种解释是正确的，我首先介绍了审后义务的分类，并通过审后伦理文献中的示例说明了其应用。然后，我简要地重构了2000年至2008年的《赫尔辛基宣言》的审判后义务的表述，以将这些变化与一些最突出的道德论据联系起来。最后，我对最新的审判后义务表述进行了批判性的解释。我认为，与以前的版本相比，《审判后条款》第34段是一种改进的表述，特别是在确定负责任的代理人和放弃模棱两可的公平利益的措词上。但是，我批评自2004年以来《宣言》中出现的获得其他适当护理的机会消失，以及研究后获得信息的义务的范围狭窄。

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