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Post‐trial obligations in the D eclaration of H elsinki 2013: classification, reconstruction and interpretation
Author(s) -
Mastroleo Ignacio
Publication year - 2016
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/dewb.12099
Subject(s) - declaration , declaration of helsinki , paragraph , interpretation (philosophy) , clinical trial , political science , law , public relations , medicine , informed consent , computer science , alternative medicine , pathology , programming language
The general aim of this article is to give a critical interpretation of post‐trial obligations towards individual research participants in the D eclaration of H elsinki 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 D eclaration of H elsinki is a great opportunity to discuss it. In my view, the D eclaration of H elsinki 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 D eclaration 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 D eclaration of H elsinki 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 D eclaration since 2004 and the narrow scope given to obligations of access to information after research.