公共卫生突发事件期间的研究伦理义务:COVID-19 大流行的启示。

IF 2.3 2区 哲学 Q1 ETHICS
Medicine Health Care and Philosophy Pub Date : 2024-03-01 Epub Date: 2023-12-28 DOI:10.1007/s11019-023-10184-6
Mariana Barosa, Euzebiusz Jamrozik, Vinay Prasad
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引用次数: 0

摘要

在危机时刻,公共卫生领导人可能会声称,对公共卫生干预措施进行试验是不道德的。出现这种说法的一个原因可能是,专家集体观点的改变扰乱了平衡状态,即专家对某项干预措施的证据存在不确定性和/或分歧。有些人可能会说,如果大多数专家认为紧急公共卫生干预措施可能利大于弊,那么这种平衡状态就会受到干扰。然而,这种想法并不总是合理的:在没有进行高质量研究的情况下,干预措施是否能带来净效益往往存在相当大的不确定性。在这篇文章中,我们认为,在突发公共卫生事件(PHEs)中,无论是在政策实施之前、期间还是之后,都必须开展高质量的研究,即通过精心设计的随机试验进行研究。我们认为,这一标准既适用于药物干预,也适用于非药物干预,并详细阐述了 "等价交换 "的概念,该概念捕捉到了近期大流行病辩论的关键特征。我们通过分析 COVID-19 大流行期间采用的有关药物、疫苗和非药物干预措施的研究策略,并对可能的反对意见做出回应,从而建立我们的论点。最后,我们提出了一项公共卫生政策改革建议:只要在公共卫生紧急事件期间实施的政策没有高质量的证据证明预期的益处大于危害,就应该有计划地生成高质量的证据,并在预设的时间点对新出现的数据进行审查。这些预设的时间点能保证决策者停下来审查新出现的证据,并考虑停止无效甚至有害的政策,从而提高透明度和问责制,并允许将资源转用于更有效或更有益的干预措施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic.

The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic.

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise-i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention-has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions.

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来源期刊
CiteScore
4.30
自引率
4.80%
发文量
64
期刊介绍: Medicine, Health Care and Philosophy: A European Journal is the official journal of the European Society for Philosophy of Medicine and Health Care. It provides a forum for international exchange of research data, theories, reports and opinions in bioethics and philosophy of medicine. The journal promotes interdisciplinary studies, and stimulates philosophical analysis centered on a common object of reflection: health care, the human effort to deal with disease, illness, death as well as health, well-being and life. Particular attention is paid to developing contributions from all European countries, and to making accessible scientific work and reports on the practice of health care ethics, from all nations, cultures and language areas in Europe.
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