Risks associated with the ethical aspects of conducting clinical trials

Хохлов, А. Л.; Полозова, Е. А.; Комиссарова, В. А.; Чудова, Н. В.; Цызман, Л. Г.

doi:10.37489/2588-0519-2020-1-61-68

Cited by 5 publications

(2 citation statements)

References 2 publications

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“…Специальной стороной оперативной этической поддержки процессов выхода из кризисной ситуации может служить солидарное объединение всех глобальных институтов и ассоциаций биоэтики, создавших в период пандемии постоянно действующие форумы в мировом информационном пространстве для обсуждения этических проблем и поиска оптимальных решений [17,24]. Отечественным примером стала деятельность Совета по этике при МЗ РФ, направленная на решение актуальных вопросов этичности проведения исследований в условиях пандемии COVID-19 и экспресс-экспертизы разработок и регистрации лекарств и вакцин, когда имеет место поиск баланса решений в интересах всего человечества и оценки рисков, которые такие решения могут за собой повлечь [15]. Известно, что при пандемии COVID-19 остро возникла необходимость не только разработки новых лекарственных препаратов и вакцин, но и создания доказательной базы о новых показаниях применения существующих в медицине средств и методов.…”

Section: практика реализации ключевых этических позиций в условиях паunclassified

“…В этом ключе можно рассматривать и постановление Правительства РФ от 3 апреля 2020 г. № 441 [15]. Однако единственно перспективным решением должна служить фундаментальная работа по созданию и перспективному включению в регуляцию клинических исследований специальных стандартных процедур этической экспертизы в чрезвычайных ситуациях, включая пандемии.…”

Section: практика реализации ключевых этических позиций в условиях паunclassified

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Second ethical comments towards COVID-19 (one year later)

Kubar

Бичурина

Romanenkova

2021

Russian Journal of Infection and Immunity

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At the beginning of COVID-19 development, when social vulnerability in the face of the global infectious threat became obvious, we presented target information on a key civilizational issue — the role of ethics in epidemic emergencies. The compliance of RF legislation and the world ethical standards analyzed on based on the study of the humanitarian heritage of pandemic management and a review of existing international documents. Today, one year later, it is time to practically evaluate the effectiveness of the ideology of ethical commitment and objectively comprehend the conflicts that have arisen, their causes and consequences. It should be emphasized that this work is not a so-called “moral lesson learned from COVID-19”, but representation of a real picture of how the centuries-old experience of former epidemics and pandemics was taken into account and the unique truth of the ethical content of management decisions and actions was accepted. It is particularly important to have a possibility to present this article as a continuation of our research topic on the bioethics of pandemics, on the pages of such an authoritative, specialized journal, which fully allows us to preserve the integrity of ideas about the humanitarian essence of anti-epidemic measures. This humanitarian parallel starts from the moment of managing a particular patient with infectious pathology until large-scale measures for eradication vaccine-preventable diseases. A comprehensive and dynamic look at the need to find ways and the nature of overcoming ethical conflicts during the ongoing pandemic of the new coronavirus infection could determine the ethical approach of longterm recommendations in the field of public health protection and ensure the stability of social trust in the future.

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Section: практика реализации ключевых этических позиций в условиях паunclassified

Second ethical comments towards COVID-19 (one year later)

Kubar

Бичурина

Romanenkova

2021

Russian Journal of Infection and Immunity

View full text Add to dashboard Cite

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Current ethical issues of clinical trials of drugs for the pathogenetic therapy of multiple sclerosis in the context of the COVID-19 pandemic

Ивашкова

Петров

Вотинцева

et al. 2021

RJTAO

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The spread of the COVID-19 pandemic posed a serious challenge for scientific and clinical medical institutions in terms of research for new multiple sclerosis (MS) treatments. In this review we discuss the associations between coronavirus infection and MS and provide data on the features of MS pathogenetic therapy during a pandemic. We also analyze the ethical aspects of clinical trials, the problems faced by researchers and patients, especially when using immunosuppressive therapy for MS. We provide examples of violations during research caused by the influence of a pandemic, as well as ways of solving them. Improving ethical standards is an essential component of ensuring the safety of MS and other immune-mediated diseases treatment.

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The third ethical commentary to COVID-19 (two years later) — vaccination, solidarity, and trust

Kubar

Микиртичан

Vladimirova³

et al. 2022

Russian Journal of Infection and Immunity

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The systematic monitoring of COVID-19 pandemic’s ethical content, carried out over the past two years, serves to develop a multi-professional discussion on one of the most relevant platforms - the journal "Infection and Immunity". Two previous articles consistently presented the moral context of historically established regulatory and epidemiological paradigms and the analysis of readiness/or unwillingness to follow them in the real conditions of the epidemic crisis. The modern moral cross-section of the pandemic, characterized by a state of global loss: values of social unity, trust and solidarity; leaves virtually no doubt about the dominant role of ethics as a criterion for resolving conflicts of interest. The point of the highest moral tension was vaccination prevention at all levels of its advancement into an effective resource for containing the COVID-19. According to the author's personal and professional responsibility, based on long-term scientific research of vaccination’s ethics, embodied in the books "Ethics of Infectious Pathology" (2014) [73] and "Ethics of vaccination (criterion of scientific and humanitarian breakthrough" (2018) [72], determined our interest in writing this work. In the "third ethical commentary" presented to the readers, two ideologically related tasks are set. First, consider the ethically verified canon of vaccine prevention on a specific example of the COVID-19 pandemic. Secondly, to expand the scope in the discussion of the ethics role by connecting the vaccination in the context of a regional cluster, namely, the CIS member states. This opportunity took place thanks to long-term cooperation on the creation of an ethical evaluation system within the framework of the WHO project "Forum of Ethics Committees in the Commonwealth of Independent States (FECCIS)" [74] and the practice of developing model laws in the field of social policy and human rights of the IPA CIS. The perspective focus of this work is the need for an innovative approach to the development of management decisions by enlarging the interdisciplinary range and expanding the areas of responsibility of social and bioethical meaning in the protection of public health in epidemic crisis.

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Risks associated with the ethical aspects of conducting clinical trials

Cited by 5 publications

References 2 publications

Second ethical comments towards COVID-19 (one year later)

Second ethical comments towards COVID-19 (one year later)

Current ethical issues of clinical trials of drugs for the pathogenetic therapy of multiple sclerosis in the context of the COVID-19 pandemic

The third ethical commentary to COVID-19 (two years later) — vaccination, solidarity, and trust

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