Post-Trial Obligations in the Declaration of Helsinki 2013
Affiliation: National Scientific and Technical Research Council (CONICET), BioThera Research Institute for the Philosophy of Translational Medicine, FLACSO collaborating centre of PAHO/WHO, Buenos Aires, Argentina
Keywords: post-trial obligations, informed consent, clinical trial, declaration of Helsinki, post-study, health care
Categories: Humanities, Social Sciences and Law
Dr. Ignacio Mastroleo works on human health research ethics. Since Feb 2015 he is a member of the Post-Trial Responsibilities Workgroup of the Multi-Regional Clinical Trial (MRCT) Center, at Harvard University. He has a PhD in Philosophy from the University of Buenos Aires and Assistant Researcher at CONICET (National Scientific and Technical Research Council of Argentina) working at the Bioethics Program of FLACSO Argentina with his advisor, Dr. Florencia Luna. He was member of the research ethics committee at the Oncology Institute of the University of Buenos Aires. Last year he was awarded the Caroline Miles Scholarship of the Ethox Centre, Oxford University, UK and The Manuel Velasco Suarez Award for Excellence in Bioethics, by the Pan American Health Organization (PAHO) and the PAHO Foundation. In this presentation Dr. Mastroleone addresses the obligations of reserachers and clinicians after the formal clinical trial is completed. 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, namely, 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 wording. However, I criticize the disappearance of “access to other appropriate care”, still present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research.