Journal of Medical Ethics 43 (12):803-809 (2017)
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Abstract |
It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies.
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DOI | 10.1136/medethics-2016-103680 |
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References found in this work BETA
Principles for Allocation of Scarce Medical Interventions.Govind Persad, Alan Wertheimer & Ezekiel J. Emanuel - 2009 - The Lancet 373 (9661):423--431.
False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.Paul S. Appelbaum, Loren H. Roth, Charles W. Lidz, Paul Benson & William Winslade - 1987 - Hastings Center Report 17 (2):20-24.
Non-Completion and Informed Consent.Alan Wertheimer - 2014 - Journal of Medical Ethics 40 (2):127-130.
Competing Clinical Trials in the Same Institution: Ethical Issues in Subject Selection and Informed Consent.Elisa J. Gordon & Kenneth C. Micetich - 2002 - IRB: Ethics & Human Research 24 (2):1.
Citations of this work BETA
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Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.Alex John London & Jonathan Kimmelman - 2019 - Hastings Center Report 49 (4):31-41.
Differential Payment to Research Participants in the Same Study: An Ethical Analysis.Govind Persad, Holly Fernandez Lynch & Emily Largent - 2019 - Journal of Medical Ethics 45 (5):318-322.
The Decision to Enroll in a Clinical Trial Should Be Unencumbered.Luke Gelinas & Barbara E. Bierer - 2020 - American Journal of Bioethics 20 (9):23-25.
On Scarcity and the Value of Clinical Trials.Luke Gelinas, Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen - 2018 - American Journal of Bioethics 18 (4):71-73.
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