The ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes

This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that • stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable. • research participants already receiving trial medicati...

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Published in:Frontiers in medicine 2022-08, Vol.9, p.950409-950409
Main Authors: Kerpel-Fronius, Sandor, Kurihara, Chieko, Crawley, Francis P., Baroutsou, Varvara, Becker, Sander, Franke-Bray, Brigitte, Matsuyama, Kotone, Naseem, Shehla, Schenk, Johanna
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Language:English
Subjects:
clinical trials
economic sanctions
ethics
investigational treatment
Medicine
Ukraine war
vulnerable population
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container_title Frontiers in medicine
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creator Kerpel-Fronius, Sandor
Kurihara, Chieko
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Franke-Bray, Brigitte
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Naseem, Shehla
Schenk, Johanna
description This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that • stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable. • research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol. • based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes. • it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.
doi_str_mv 10.3389/fmed.2022.950409
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subjects clinical trials
economic sanctions
ethics
investigational treatment
Medicine
Ukraine war
vulnerable population
title The ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes
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