Background::Recent studies using mass drug administration(MDA)of antibiotics to entire communities have focused global attention on the unique ethical challenges of MDA of antibiotics in research and public health int...Background::Recent studies using mass drug administration(MDA)of antibiotics to entire communities have focused global attention on the unique ethical challenges of MDA of antibiotics in research and public health interventions.However,there is no specific guidance for Research Ethics Committees(RECs)or Institutional Review Boards(IRBs)to review such trials.We surveyed the literature to identify the unique ethical challenges and to strengthen the competencies of RECs or IRBs in low-and middle-income countries(LMICs)in their ethical reviews of these trials.Methods::We employed a desk review.We searched PubMed,Web of Science,and Google Scholar,combining terms for"mass drug administration"with terms for"research ethics committees,""institutional review boards,"and"ethics."We reviewed citations of search results to retrieve additional articles.Only articles published and indexed in the above databases up to 6 January 2022 in English were included.Abstracts(without full articles),books and articles that had exclusive veterinary and environmental focus were excluded.We synthesized the literature to identify particularly challenging ethical issues relevant to antibacterial MDA trials in LMICs.Results::The most challenging ethical issues can be categorised into four broad domains:determining the social value of MDA,assessing risks and benefits,engaging all stakeholders meaningfully,and study design-related ethical challenges.These four domains interact and impact each other.Together,they reveal the need for RECs/IRBs to review MDA studies through a broader lens than that of clinical trials per se.From our findings,we propose a framework to guide the RECs and IRBs in LMICs to perform the initial and continuing review of antibiotic MDA trials.We also recommend strengthening the competencies of LMIC RECs or IRBs through ongoing training and collaboration with RECs or IRBs from high-income countries.Conclusions::REC/IRB review of research using MDA of antibiotics plays a critical role in assuring the ethical conduct of MDA s展开更多
美国食品药品管理局(Food and Drug Administration,FDA)于2022年2月发布了“用于急性疼痛的非阿片类镇痛药的开发供企业用的指导原则草案”,旨在帮助申请人开发用于治疗持续30 d的急性疼痛的阿片类药物替代品,促进这类药物的发展,减少...美国食品药品管理局(Food and Drug Administration,FDA)于2022年2月发布了“用于急性疼痛的非阿片类镇痛药的开发供企业用的指导原则草案”,旨在帮助申请人开发用于治疗持续30 d的急性疼痛的阿片类药物替代品,促进这类药物的发展,减少阿片类药物的使用,对抗阿片类药物的误用、滥用和成瘾。该指导原则阐述了FDA目前对下列3方面的具体看法:用于急性疼痛的非阿片类镇痛药的临床试验方案、其说明书中关于消除或减少阿片类药物使用的描述以及这类药物的加快审批程序。重点是前两者,尤其是临床试验方案。而中国目前还没有类似的指导原则,详细介绍该指导原则,期望对中国这类药物的临床研究及其监管有所帮助。展开更多
基金This work was supported under a Greenwall Foundation (G# 134972) grant on the "Mass Administration of Antibiotics: Reaching Clinical and Community Equipoise" as part of the Making a Difference in Real-World Bioethics Dilemmas program. The Greenwall Foundation did not have a role in the design of the study, collection, analysis, and interpretation of data or in writing the manuscript.
文摘Background::Recent studies using mass drug administration(MDA)of antibiotics to entire communities have focused global attention on the unique ethical challenges of MDA of antibiotics in research and public health interventions.However,there is no specific guidance for Research Ethics Committees(RECs)or Institutional Review Boards(IRBs)to review such trials.We surveyed the literature to identify the unique ethical challenges and to strengthen the competencies of RECs or IRBs in low-and middle-income countries(LMICs)in their ethical reviews of these trials.Methods::We employed a desk review.We searched PubMed,Web of Science,and Google Scholar,combining terms for"mass drug administration"with terms for"research ethics committees,""institutional review boards,"and"ethics."We reviewed citations of search results to retrieve additional articles.Only articles published and indexed in the above databases up to 6 January 2022 in English were included.Abstracts(without full articles),books and articles that had exclusive veterinary and environmental focus were excluded.We synthesized the literature to identify particularly challenging ethical issues relevant to antibacterial MDA trials in LMICs.Results::The most challenging ethical issues can be categorised into four broad domains:determining the social value of MDA,assessing risks and benefits,engaging all stakeholders meaningfully,and study design-related ethical challenges.These four domains interact and impact each other.Together,they reveal the need for RECs/IRBs to review MDA studies through a broader lens than that of clinical trials per se.From our findings,we propose a framework to guide the RECs and IRBs in LMICs to perform the initial and continuing review of antibiotic MDA trials.We also recommend strengthening the competencies of LMIC RECs or IRBs through ongoing training and collaboration with RECs or IRBs from high-income countries.Conclusions::REC/IRB review of research using MDA of antibiotics plays a critical role in assuring the ethical conduct of MDA s
文摘美国食品药品管理局(Food and Drug Administration,FDA)于2022年2月发布了“用于急性疼痛的非阿片类镇痛药的开发供企业用的指导原则草案”,旨在帮助申请人开发用于治疗持续30 d的急性疼痛的阿片类药物替代品,促进这类药物的发展,减少阿片类药物的使用,对抗阿片类药物的误用、滥用和成瘾。该指导原则阐述了FDA目前对下列3方面的具体看法:用于急性疼痛的非阿片类镇痛药的临床试验方案、其说明书中关于消除或减少阿片类药物使用的描述以及这类药物的加快审批程序。重点是前两者,尤其是临床试验方案。而中国目前还没有类似的指导原则,详细介绍该指导原则,期望对中国这类药物的临床研究及其监管有所帮助。
