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

Sandor Kerpel-Fronius; Chieko Kurihara; Francis P Crawley; Varvara Baroutsou; Sander Becker; Brigitte Franke-Bray; Kotone Matsuyama; Shehla Naseem; Johanna Schenk

doi:10.3389/fmed.2022.950409

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

Front Med (Lausanne). 2022 Aug 9:9:950409. doi: 10.3389/fmed.2022.950409. eCollection 2022.

Authors

Sandor Kerpel-Fronius¹, Chieko Kurihara², Francis P Crawley³, Varvara Baroutsou⁴, Sander Becker⁵, Brigitte Franke-Bray⁶, Kotone Matsuyama⁷, Shehla Naseem⁸, Johanna Schenk⁹

Affiliations

¹ Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary.
² Kanagawa Dental University, Kanagawa, Japan.
³ Good Clinical Practice Alliance-Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review, Leuven, Belgium.
⁴ Consultant, Pharmaceutical Medicine, Athens, Greece.
⁵ Consultant in Pharmaceutical Medicine, Dover Heights, NSW, Australia.
⁶ Independent Consultant, Basel, Switzerland.
⁷ Department of Health Policy and Management, Nippon Medical School, Tokyo, Japan.
⁸ Ferozsons Laboratories Ltd, Karachi, Pakistan.
⁹ PPH plus GmbH & Co. KG, Hochheim am Main, Germany.

Abstract

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.

Keywords: Ukraine war; clinical trials; economic sanctions; ethics; investigational treatment; vulnerable population.