Should desperate volunteers be included in randomised controlled trials?
Journal of Medical Ethics 32 (9):548-553 (2006)
Abstract
Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguements that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.Author's Profile
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Citations of this work
Exploitative, irresistible, and coercive offers: why research participants should be paid well or not at all.Sara Belfrage - 2016 - Journal of Global Ethics 12 (1):69-86.
Ethical Issues in Deep Brain Stimulation Research for Treatment-Resistant Depression: Focus on Risk and Consent.Laura B. Dunn, Paul E. Holtzheimer, Jinger G. Hoop, Helen S. Mayberg, Laura Weiss Roberts & Paul S. Appelbaum - 2011 - American Journal of Bioethics Neuroscience 2 (1):29-36.
Questioning Assumptions About Vulnerability in Psychiatric Patients.Melissa D. McCradden & Michael D. Cusimano - 2018 - American Journal of Bioethics Neuroscience 9 (4):221-223.
References found in this work
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A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials.Franklin G. Miller & Howard Brody - 2003 - Hastings Center Report 33 (3):19-28.
The clinician-investigator: Unavoidable but manageable tension.Howard Brody & Franklin G. Miller - 2003 - Kennedy Institute of Ethics Journal 13 (4):329-346.
Rehabilitating Equipoise.Paul B. Miller & Charles Weijer - 2003 - Kennedy Institute of Ethics Journal 13 (2):93-118.
The ubiquity and utility of the therapeutic misconception.Rebecca Dresser - 2002 - Social Philosophy and Policy 19 (2):271-294.