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

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.

Declaration of Helsinki: ethical norm in pursuit of common global goals

“…Other unprecedented situations of clinical trials in war/conflict, as well as natural disasters, highlighted the needs of patients seeking access to investigational intervention ( 39 , 40 ). Sponsors, investigators, and regulators ( 41–43 ), undertook joint efforts to continue or start investigational treatment for patients with acute needs, and developed procedures for adherence to GCP under disruptive circumstances, including the cases of emigrations.…”

The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines

“…The provision of essential healthcare to those finding themselves in situations of conflict must be a first priority. The Ethics Working Group of the IFAPP have stressed the importance of continuing, where and as possible, the investigational treatments offered to patients already enrolled in clinical trials in countries stricken by various types of disruptive catastrophes (5,6). There is now a need to review our understanding of clinical research in the context of crisis situations, taking into account a broader appreciation of what must be included in the fundamental right to health (7) as well as the emerging positive interpretation of the rights of study participants to access to potentially vital interventions provided through clinical research and possibly "identified as beneficial in the trial" (8).…”