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

MASTROLEO, IGNACIO

DEVELOPING WORLD BIOETHICS

WILEY-BLACKWELL PUBLISHING, INC

Lugar: Londres; Año: 2016 vol. 16 p. 80 - 90

1471-8731

DEVELOPING WORLD BIOETHICS [ISSN 1471-8731] Nivel CONICET (Res. 2249/14) : Grupo 1. Datos de indización: Scopus**********************************************************************************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