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Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations.沙特阿拉伯的机构审查委员会:基于调查的首次关于其职能和运作的报告。
BMC Med Ethics. 2023 Jul 10;24(1):50. doi: 10.1186/s12910-023-00928-7.
2
Challenges and recommendations to improve institutional review boards' review of community-engaged research proposals: A scoping review.改善机构审查委员会对社区参与研究提案审查的挑战与建议:一项范围综述。
J Clin Transl Sci. 2023 Mar 31;7(1):e93. doi: 10.1017/cts.2023.516. eCollection 2023.
3
Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees.在 COVID-19 研究中遇到的关键伦理问题:南非研究伦理委员会观点的主题分析。
BMC Med Ethics. 2023 Feb 15;24(1):11. doi: 10.1186/s12910-023-00888-y.
4
Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review.加强撒哈拉以南非洲与健康相关研究的伦理委员会:范围综述。
BMJ Open. 2022 Nov 21;12(11):e062847. doi: 10.1136/bmjopen-2022-062847.
5
Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts.研究中的伦理问题:研究人员、研究伦理委员会成员及研究伦理专家的看法
J Acad Ethics. 2023;21(2):269-292. doi: 10.1007/s10805-022-09455-3. Epub 2022 Aug 12.
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Published Research on COVID-19 in the Eastern Mediterranean Region: Bibliometric Analysis.东地中海区域关于COVID-19的已发表研究:文献计量分析
Interact J Med Res. 2022 Jul 19;11(2):e38935. doi: 10.2196/38935.
7
A systematic scoping review of undergraduate medical ethics education programs from 1990 to 2020.从 1990 年到 2020 年,对本科医学伦理学教育项目进行系统的范围综述。
Med Teach. 2022 Feb;44(2):167-186. doi: 10.1080/0142159X.2021.1970729. Epub 2021 Sep 17.
8
A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era.呼吁在新冠疫情时代加强而不是加速研究伦理委员会审查。
Ethics Hum Res. 2021 Sep;43(5):42-44. doi: 10.1002/eahr.500104.
9
Knowledge, Awareness, Attitudes, and Practices towards Research Ethics and Research Ethics Committees among Myanmar Post-graduate Students.缅甸研究生对研究伦理及研究伦理委员会的认知、意识、态度和行为
Asian Bioeth Rev. 2020 Sep 26;12(4):379-398. doi: 10.1007/s41649-020-00148-w. eCollection 2020 Dec.
10
Assessment of research ethics education offerings of pharmacy master programs in an Arab nation relative to top programs worldwide: A qualitative content analysis.评估一个阿拉伯国家药学硕士项目的研究伦理教育课程与全球顶尖项目的相对情况:一项定性内容分析。
PLoS One. 2021 Feb 19;16(2):e0238755. doi: 10.1371/journal.pone.0238755. eCollection 2021.

研究伦理委员会监督的幕后:在中东和北非地区进行的一项委员会主席的定性研究。

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region.

机构信息

Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Bliss Street, Beirut, 1107 2020, Lebanon.

Global and Community Health Department, George Mason University, Fairfax, VA, USA.

出版信息

BMC Med Ethics. 2024 Aug 8;25(1):86. doi: 10.1186/s12910-024-01083-3.

DOI:10.1186/s12910-024-01083-3
PMID:39118102
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11308332/
Abstract

BACKGROUND

Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations.

METHODS

Virtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes.

RESULTS

Two sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers' competence in both applied research ethics and research methodology as revealed by their applications.

CONCLUSIONS

Narratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

摘要

背景

研究指出,包括阿拉伯国家在内的世界许多地区的研究伦理委员会都存在缺陷和挑战。本文通过对研究伦理委员会(REC)主席的深入访谈,探讨了他们对监督涉及人类人群的研究工作中面临的挑战的看法,这些访谈是基于定性的。

方法

对来自六个国家的生物医学和/或社会行为研究伦理委员会的主席进行了虚拟深入访谈(n=11),对访谈内容进行了转录、编码,并进行了主题分析,以确定反复出现的主题。

结果

有两组反复出现的主题阻碍了委员会的工作,并对研究应用的质量提出了担忧:(1)程序和委员会层面的挑战,如工作量大、成员资格差异、阻碍官僚程序、成员过度工作以及审查过程中的交叉社会文化价值观;(2)研究人员在应用研究伦理和研究方法方面的能力不一致,这体现在他们的申请中。

结论

REC 主席的叙述对于阐明调查中未捕捉到的经验和问题很重要,为该地区和世界其他中低收入国家(LMICs)的知识体系增添了内容。国际研究合作可以从这些发现中受益。