Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research

Norman M.Goldfarb

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Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research

机译：信任系统：研究伦理委员会和生物医学研究的监管

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Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research looks at ethical review in the UK through the lens of trust: Investigators must trust research ethics committees (RECs) — the UK’s version of institutional review boards (IRBs) — to give their applications a fair hearing. REKs must trust investigators to conduct their clinical studies per their applications (under supervision by study sponsors that may not share the REK’s ethical perspectives). Study participants, who likely have, at best, only a vague understanding that RECs exist at all, must trust the system. The author reviews the relevant literature and describes his own ethnographic research on RECs, including you-arethere discussions.

机译：信任系统：研究伦理委员会和生物医学研究的监管通过信赖的镜头看着英国的道德审查：调查人员必须信任研究伦理委员会（RECS） - 英国版的机构审查委员会（IRBS）的版本 - 给予他们的应用是公平的听证会。 REKS必须信任调查人员按照其申请进行临床研究（通过审查发起人监督，可能无法分享REK的道德观点）。研究参与者可能拥有最多只有模糊的理解，全部存在REC，必须相信该系统。作者审查了相关文献，并描述了他对Recs的民族教态研究，包括您 - 替补讨论。

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《Journal of Clinical Research Best Practices》 |2021年第3期|共2页
作者
Norman M.Goldfarb;
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中图分类临床医学;
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1. Role of the ethics committees for investigation (CEI) and ethics committees for investigation with medicinal products (CEIM) in follow-up activities on biomedical research studies [J] . de Pablo Itziar, Angeles Galvez M., del Alamo Marta, Basic & clinical pharmacology & toxicology. . 2019,第S4期

机译：伦理委员会调查（CEI）和伦理委员会在生物医学研究研究的后续活动中调查的伦理委员会和伦理委员会的作用
2. Research Ethics Committees' Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols [J] . Silaigwana Blessing, Wassenaar Douglas Journal of empirical research on human research ethics : . 2019,第2期

机译：研究伦理委员会对南非生物医学研究的监督：非加快议定书伦理审查期间伦理问题的主题分析
3. A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects. [J] . Lamas E, Ferrer M, Molina A, Journal of medical ethics . 2010,第12期

机译：欧洲和拉丁美洲在保护人类受试者方面的生物医学研究道德规范体系的比较分析。
4. The Welcome Trust's Programme in Biomedical Ethics [C] . Spallone, P. . 1998

机译：惠康生物医学伦理学信托计划
5. Letting the people decide: A study of the Citizens' Committee on Biomedical Ethics, Inc. and its citizen-leaders. [D] . Lowe, Jane Isaacs. 1991

机译：由人民决定：对生物医学伦理学公民委员会及其公民领导者的研究。
6. A clinical ethics committee in a small health service trust. [O] . K A Wood, S Ellis 1999

机译：小型卫生服务信托基金中的临床伦理委员会。
7. Perfil dos Comitês de Ética em Pesquisa no Brasil: uma análise do sistema de regulação ética da pesquisa clínica, pontos estratégicos e desafios / Profile of Human Research Ethics Committees in Brazil: an analysis of clinical research ethics regulation system, strategic points and challenges [O] . Ingrid Pereira Rodrigues Barbosa, Fernando De Rezende Francisco, Luis Lopez Martinez 2018

机译：巴西研究中的伦理委员会概况：巴西人研究伦理委员会临床研究，战略点和挑战的伦理监管制度分析：临床研究伦理监管系统，战略点和挑战分析

Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research

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