Facilitating Ukrainian Refugees’ Continued Participation in Clinical Trials

Russia's invasion of Ukraine and the ongoing armed conflict are having a hugely damaging effect on health services and the health infrastructure in Ukraine. Hundreds of clinical trials have been halted, leaving patients without access to treatment and jeopardizing the development of promising n...

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Vydané v:The Hastings Center report Ročník 52; číslo 3; s. 6 - 8
Hlavní autori: Bloswick, Agata, Mustra, David, Harasymiv, Oksana, Dubov, Alex
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Blackwell Publishing Ltd 01.05.2022
Predmet:
bioethics
Clinical research
Clinical trials
Clinical Trials as Topic
Data
Data integrity
Drugs
Ethics, Research
Handover
Health services
Humans
Infrastructure
Medical ethics
Medical treatment
Morality
participants in human subjects research
Patients
reenrollment
Refugees
Research ethics
Research Personnel
Research Subjects
Risk assessment
Ukraine
Ukrainian language
Ukraine
refugees
bioethics
reenrollment
Ukraine
clinical trials
research ethics
participants in human subjects research
ISSN:0093-0334, 1552-146X, 1552-146X
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Shrnutí:Russia's invasion of Ukraine and the ongoing armed conflict are having a hugely damaging effect on health services and the health infrastructure in Ukraine. Hundreds of clinical trials have been halted, leaving patients without access to treatment and jeopardizing the development of promising new drugs. There is a lack of clarity on dealing with protocol deviations and other disruptions caused by war. This article proposes guidance on facilitating Ukrainian refugees’ continuation in clinical trials. The safety of study participants should be the main priority and guide every decision, regardless of any potential consequences for an ongoing trial. This commentary outlines policy recommendations regarding participants’ reenrollment, the handover of participants and data to new principal investigators, and the consent process as well as the sponsor's obligations related to translation, data transfer, and support for Ukrainian investigators. To ensure data integrity, investigators should carry out risk assessments of the further use of refugees’ data.
Bibliografia:ObjectType-Article-1
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ISSN:0093-0334
1552-146X
1552-146X
DOI:10.1002/hast.1390