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Ethics and etiquette in an emergency vaccine trial. The orchestration of compliance

Participant non-compliance and withdrawal from randomized clinical trials has increased focus on analysing the results from the “per-protocol” population that complies with a trial’s protocols. There is no clear understanding of what shapes protocol compliance in practice. In this paper, I theorize...

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Detalles Bibliográficos
Autor principal: Alenichev, Arsenii
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Routledge 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048227/
https://www.ncbi.nlm.nih.gov/pubmed/32158366
http://dx.doi.org/10.1080/11287462.2020.1726591
Descripción
Sumario:Participant non-compliance and withdrawal from randomized clinical trials has increased focus on analysing the results from the “per-protocol” population that complies with a trial’s protocols. There is no clear understanding of what shapes protocol compliance in practice. In this paper, I theorize clinical research from the perspective of participants in an Ebola vaccine trial by analysing the practices that contributed to very high compliance rates. In this setting, per-protocol compliance became an essential component in forming a class of “proper” researchers and participants working together in the rapidly expanding market of clinical research. Bioethics supports participants’ right to withdraw from research as an ethical safeguard in the process. But participants seeking affiliations with powerful institutions may voluntarily embrace their trial responsibilities over a right to withdraw. To understand this phenomenon, this analysis uses the notion of bioetiquette – the set of rules specifying “proper” and “improper” trial subjects and behaviours – which runs in the shadow of formal bioethics in trials and requires careful transdisciplinary examination.