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Developing World Bioethics
Article . 2015 . Peer-reviewed
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Post‐trial obligations in theDeclaration ofHelsinki 2013: classification, reconstruction and interpretation

Authors: Mastroleo, Ignacio Damian;

Post‐trial obligations in theDeclaration ofHelsinki 2013: classification, reconstruction and interpretation

Abstract

AbstractThe general aim of this article is to give a critical interpretation of post‐trial obligations towards individual research participants in theDeclaration ofHelsinki 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 theDeclaration ofHelsinki is a great opportunity to discuss it. In my view, theDeclaration ofHelsinki 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. TheDeclaration 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 theDeclaration ofHelsinki 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 theDeclaration since 2004 and the narrow scope given to obligations of access to information after research.

Country
Argentina
Keywords

Clinical Trials as Topic, Research, Research Ethics, Ethics, Research, Human Experimentation, Right to Health, https://purl.org/becyt/ford/6.3, https://purl.org/becyt/ford/3.3, Terminology as Topic, Practice Guidelines as Topic, https://purl.org/becyt/ford/6, Humans, https://purl.org/becyt/ford/3, Post-Trial Access Ethics, Benefit Sharing, Helsinki Declaration

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    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
39
Top 10%
Top 10%
Top 10%
Green