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

Abstract

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.

Keywords:

• informed consent
• research ethics

Notes

1. Other labels besides siOAT can be found in the literature, especially heroin-assisted treatment (HAT). We use siOAT because it highlights the possibility that the prescribed opioid might not be diacetylmorphine, as illustrated by some of the research we describe.

2. Thus, siOAT research is an exception to the “catch-22” of research on schedule 1 drugs, in which classification as having no medical benefit prevents research that could show benefit (Andreae et al. 2016).

3. For testimonials from patients at the Providence Crosstown Clinic that attest to these issues, see http://fromharmtohealing.com/literature.

4. Although Henden writes “if” here, the logic of his argument requires that he mean either “only if” or “if and only if.” That is, his argument requires a necessary condition for voluntary choice, so that a choice made because no other acceptable alternatives were available is not voluntary.

5. Some critics construe Henden's voluntariness criterion as a necessary condition for accessing medical treatment (Levy 2016, 70). Henden does not present his criterion in this manner, nor is that a charitable interpretation, given that urgent medical problems frequently force people to choose the least bad of a bad lot.

6. Indeed, Henden does not seem to view siOAT as a treatment at all. Besides referring to it as “free heroin,” he also states, “Participation [in siOAT research] might be seen as a step toward accessing proper treatment” (Henden 2016, 294). This appears to imply that siOAT itself is not a “proper treatment.”

7. While consent is retained as a fundamental requirement in subsequent research ethics codes, the Nuremberg Code is distinctive in its use of the phrase “voluntary consent” (cf. Rhodes 2005).

8. Similar ideas are found in the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, article 17, and in Guideline 15 of CIOMS (2016).

9. London (2005) similarly criticizes what he terms “minimalist” approaches to research ethics in developing countries for tending to obscure the import of broader social injustices.