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加强公共卫生危机期间多地点研究的伦理审查的互惠性、公平性和质量:COVID-19 临床研究联盟伦理工作组的经验。

Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group.

机构信息

BAYLOR COLLEGE OF MEDICINE, HOUSTON, TX, USA.

SAFE MOTHER AND CHILDHOOD RESEARCH INITIATIVE (SAMOCRI), NIGERIA.

出版信息

J Law Med Ethics. 2023;51(2):258-270. doi: 10.1017/jme.2023.75. Epub 2023 Sep 1.

Abstract

In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.

摘要

在本文中,我们报告了委托给 COVID-19 临床研究联盟的一份报告的结果,该报告探讨了在公共卫生紧急情况下简化多国伦理审查委员会(REC)审查/批准的方法。正如文献中目前设想的那样,基于共享的程序伦理审查委员会标准,理论上可以建立一个伦理审查委员会相互认可的系统,但这引发了许多关于不公平和不信任的担忧。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abbb/10881265/bac1d9da7ade/S107311052300075X_fig1.jpg

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