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The Moral Case for Granting Catastrophically Ill Patients the Right to Access Unregistered Medical Interventions

Published online by Cambridge University Press:  01 January 2021

Udo Schuklenk  and
Ricardo Smalling
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Abstract

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions (UMI), without having to enrol in randomized placebo controlled trials.

A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not prioritise trial recruitment over patient access, even if this results in drug research and development delays.

We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial (RCT) is defended.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue 3: Symposium - Controversies in Clinical Research Ethics , Fall 2017 , pp. 382 - 391
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

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