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基于全面需求评估调查结果,在整个非洲开展伦理审查委员会能力建设。

Capacity building of ethics review committees across Africa based on the results of a comprehensive needs assessment survey.

机构信息

African Malaria Network Trust, Dar es Salaam 33207, Tanzania.

出版信息

Dev World Bioeth. 2009 Dec;9(3):149-56. doi: 10.1111/j.1471-8847.2008.00243.x.

Abstract

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.

摘要

为了确定伦理审查委员会(ERC)在伦理审查能力方面的主要需求和薄弱环节,对非洲各地的 ERC 进行了一项需求评估调查。回应率为 84%(目标委员会中的 31 个),调查的委员会位于 18 个非洲国家。大多数回应的委员会(61%)已经存在了 5 到 10 年;约 74%的受访者为机构委员会,其余的是国家委员会(31 个中的 6 个)或区域委员会(31 个中的 2 个)。在伦理审查过程方面,31 个回应的委员会中有 9 个没有标准操作规程(SOPs),而在有 SOPs 的 22 个委员会中,有 7 个自最初制定以来从未修订过(平均时间为三年)。在 31 个委员会中,有 10 个没有任何伦理准则。许多委员会(30 个中的 13 个)每月开会一次,每年审查的提案数量从五个到一百多个不等。所有受访者都依赖基于纸质的数据管理和存档系统。总的来说,调查确定了 ERC 的主要制约因素是缺乏办公设备、过时或缺乏 SOPs、缺乏电子数据管理系统、资源不足、委员会缺乏或缺乏专业知识,以及对委员会作用的重要性认识不足。因此,作者正在通过比尔和梅琳达·盖茨基金会资助的能力建设项目来解决这些已确定的需求和薄弱环节。干预项目的影响将在为期四年的纵向项目期间和结束时进行评估。

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