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Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19

Abstract : The COVID-19 epidemic has led to the intense mobilization of all health professionals, including those involved in research. From the very beginning, research ethics committees (RECs) have been called upon and mobilized to carry out the scientific and ethical evaluations of research projects to achieve a sound analysis of their risk/benefit balance. The aim of this article is to present an ethical reflection on the challenges and consequences of the fast-track procedure for the evaluation of COVID-19 research projects in the context of a public health emergency. Indeed, a large number of protocols of reduced rigor were hastily prepared without collaboration between researchers and in the absence of national regulation. As a result, a number of ethical dilemmas have emerged concerning the opposing needs of pragmatism imposed by the emergency context and the ethical principles that should govern the conduct of research. Moreover, the dispersion of these individual projects, aggravated by excessive media coverage of specific treatments, has resulted in a weakened impact of the research in the epidemic context. This article provides suggestions for the ethical management of ongoing and upcoming research, giving RECs the opportunity to adapt their evaluations to avoid allowing the pragmatism of the emergency context to subvert the inviolability of the epistemological and ethical principles of research on humans. This reflection may strengthen the ethical basis for the formulation of their decisions.
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Soumis le : mercredi 17 novembre 2021 - 10:32:16
Dernière modification le : jeudi 18 novembre 2021 - 14:25:56

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C. Bahans, Sophie Leymarie, Dominique Malauzat, Murielle Girard, Claire Demiot. Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19. Ethics, Medicine and Public Health, Elsevier, 2021, 16, pp.100621. ⟨10.1016/j.jemep.2020.100621⟩. ⟨hal-03432216⟩

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