Identifying structures, processes, resources and needs of research ethics committees in Egypt.
Identifying structures, processes, resources and needs of research ethics committees in Egypt.
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DOI：
10.1186/1472-6939-11-12
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发表时间：
2010-06-28
影响因子：
2.7
通讯作者：
Silverman HJ
中科院分区：
文献类型：
--
作者：
Sleem H;El-Kamary SS;Silverman HJ
有人对发展中国家是否有适当的道德审查制度表示关切。关于中东地区研究伦理委员会（REC）的结构和功能状况的数据有限。本研究的目的是调查埃及现有的区域经济共同体，以更好地了解其运作状况，感知的资源需求和挑战。我们向埃及区域经济委员会分发了一个自我管理的调查工具，以收集以下领域的信息：区域经济委员会的一般特点、成员组成、道德操守培训、工作量、道德操守审查程序、有效运作所面临的挑战以及财政和物质资源。我们使用基本的描述性统计来评估定量数据。我们从67%（12/18）的识别REC中获得了响应。大多数区域经济共同体（10/12）都有标准的操作程序，许多区域经济共同体（7/12）都制定了管理利益冲突的政策。平均成员人数为10.3人，范围为7至19人。主要的成员类型是医生（占所有REC成员的69.5%），很少有非专业代表（13.7%）。大多数区域经济委员会每月至少召开一次会议，每次会议审查的方案平均数量为3.8，范围为1-10。来自所有12个区域经济共同体的近四分之三的成员表示，他们接受了一些正式的道德操守培训。关于资源，大约一半的区域经济共同体拥有专用资本设备（例如，会议室、计算机、办公家具等）;没有一个区域经济共同体有正式的业务预算。人们认识到的挑战包括缺乏国家研究道德准则和区域经济共同体国家标准，以及缺乏对成员进行的研究道德培训。我们的研究记录了埃及区域经济共同体业务的几个优势领域和需要改进的领域。关于优势，许多现有的区域伦理委员会经常开会，大多数成员都受过研究伦理方面的培训，并有书面政策。关于需要改进的领域，许多区域经济共同体应努力使成员更加多样化，并应获得更多的财政资源和行政支助人员。我们建议区域经济共同体包括更多来自社区的个人，并为其成员制定继续教育计划。机构官员应了解其区域经济共同体的资源能力需求。
Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs.
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影响因子：
2.7
作者：
Moodley K;Myer L
通讯作者：
Myer L
DOI：
10.1080/08989620214683
发表时间：
2002-07-01
期刊：
Accountability in research
影响因子：
--
作者：
De Vries, Raymond G;Forsberg, Carl P
通讯作者：
Forsberg, Carl P
DOI：
10.2307/3563634
发表时间：
2003-03-01
期刊：
IRB
影响因子：
--
作者：
Kass, Nancy;Dawson, Liza;Loyo-Berrios, Nilsa I
通讯作者：
Loyo-Berrios, Nilsa I
影响因子：
4.1
作者：
Hyder, AA;Wali, SA;Dawson, L
通讯作者：
Dawson, L
影响因子：
4.1
作者：
Schuppli, C. A.;Fraser, D.
通讯作者：
Fraser, D.