Developing World Bioethics 16 (2):80-90 (2016)

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.
Keywords information after research  right to health  research ethics  health care after research  benefit sharing  moral obligation  post‐trial access ethics
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Reprint years 2016
DOI 10.1111/dewb.12099
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References found in this work BETA

Just Health: Meeting Health Needs Fairly.Norman Daniels - 2007 - Cambridge University Press.
Political Liberalism.J. Rawls - 1995 - Tijdschrift Voor Filosofie 57 (3):596-598.
Political Liberalism by John Rawls. [REVIEW]Philip Pettit - 1994 - Journal of Philosophy 91 (4):215-220.

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The Ethics of Explantation.Sven Ove Hansson - 2021 - BMC Medical Ethics 22 (1):1-9.

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