呼吁在Covid-19时代进行更好而不是更快的研究伦理委员会审查

Q2 Social Sciences
Leonardo Tamariz, Fred J. Hendler, John M. Wells, Annette Anderson, Stephen Bartlett
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引用次数: 6

摘要

随着SARS-CoV2的迅速传播,临床研究的迅速增加,给需要审查研究提案的研究伦理委员会(RECS)带来了相当大的压力。RECs面临着迅速通过审查程序的压力,以便能够开展研究以应对大流行。这些委员会还被要求在不放松伦理审查标准的情况下提高效率。RECs习惯于外部压力来获得调查人员的批准;然而,在Covid-19时代,这种压力不仅来自赞助商和调查人员,还来自许多其他利益攸关方,包括世界领导人、社区、媒体和专业组织。根据作者在中央REC审查复杂的多中心Covid-19研究的经验,本评论描述了Covid-19研究固有的挑战,例如难以从患有高传染性病毒的患者那里获得知情同意。该评论建议,在2019冠状病毒病大流行和未来传染病暴发期间,研究委员会可采取若干步骤,确保对研究进行伦理审查。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.

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来源期刊
Ethics & human research
Ethics & human research Social Sciences-Health (social science)
CiteScore
2.90
自引率
0.00%
发文量
35
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