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American Journal of Bioethics.

Our Life Depends on This Drug: Competence, Inequity, and Voluntary Consent in Clinical Trials on Supervised Injectable Opioid Assisted Treatment

Supervised injectable opioid assisted treament (siOAT) prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it should be considered in the context of inequities in access to siOAT as a medical treatment. Consequently, we suggest that bioethics literature on nonexploitation, which focuses on clinical research in low-income countries, is helpful due to locating ethical issues within systemic social conditions. Finally, we consider the implications of our argument for the ethics of clinical research on siOAT.

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Volume 17, Issue 12
December 2017

Target Articles.

Reframing Consent for Clinical Research: A Function-Based Approach Neal W. Dickert, Nir Eyal, Sara F. Goldkind, Christine Grady, Steven Joffe, Bernard Lo, Franklin G. Miller, Rebecca D. Pentz, Robert Silbergleit, Kevin P. Weinfurt, David Wendler & Scott Y. H. Kim