More considerations on post-trial obligations in the Declaration of Helsinki 2013

Abstract

The problem of transitioning research participants to the appropriate health care when the study finishes is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to discuss it. My interpretation of the Declaration of Helsinki 2013 identifies two different types of post-trial obligations, namely, access to care and access to information after research. The intended beneficiaries of these obligations are individual participants of 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 the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. I then make a brief conceptual reconstruction of formulations of post-trial obligations in earlier versions of the Declaration and revise its main critiques. Finally I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections.

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