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坦桑尼亚卫生研究伦理审查及机构伦理委员会的需求

Health research ethics review and needs of institutional ethics committees in Tanzania.

作者信息

Ikingura J K B, Kruger M, Zeleke W

机构信息

National Institute for Medical Research, P.O. Box 9653, Dar es Salaam, Tanzania.

出版信息

Tanzan Health Res Bull. 2007 Sep;9(3):154-8. doi: 10.4314/thrb.v9i3.14320.

DOI:10.4314/thrb.v9i3.14320
PMID:18087891
Abstract

This study was undertaken to describe the performance of health research ethics review procedures of six research centres in Tanzania. Data collection was done through a self-administered questionnaire and personal interviews. The results showed that there were on average 11 members (range = 8-14) in each Research Ethic Committee. However, female representation in the committees was low (15.2%). The largest proportion of the committee members was biomedical scientists (51.5%). Others included medical doctors (19.7%), social scientists (7.6%), laboratory technologists (10.6%), religious leaders (4.5%), statisticians (3.0%), teachers (1.5%) and lawyers (1.5). Committee members had different capacities to carry out review of research proposals (no capacity = 2%; limited capacity = 15%; moderate capacity = 20%; good capacity = 48%, excellent capacity = 13%). Only half of the respondents had prior ethics review training. Although the majority deemed that ethical guidelines were very important (66%), there were challenges in the use of ethical guidelines which included lack of awareness on the national accreditation mechanisms for ethics committee (59%). Adherence to ethical principles and regulations was influenced by being a scientist (OR = 42.47), being an employee of a professional organization (OR = 15.25), and having an interests in the use of ethical guidelines (OR = 10.85) These findings indicate the need for capacity strengthening (through training and resource support), inclusion of more female representation and other mandatory professions to the research ethics committees.

摘要

本研究旨在描述坦桑尼亚六个研究中心的健康研究伦理审查程序的执行情况。数据收集通过自填式问卷和个人访谈进行。结果显示,每个研究伦理委员会平均有11名成员(范围为8至14名)。然而,委员会中女性代表比例较低(15.2%)。委员会成员中比例最大的是生物医学科学家(51.5%)。其他成员包括医生(19.7%)、社会科学家(7.6%)、实验室技术人员(10.6%)、宗教领袖(4.5%)、统计学家(3.0%)、教师(1.5%)和律师(1.5%)。委员会成员审查研究提案的能力各不相同(无能力=2%;能力有限=15%;能力中等=20%;能力良好=48%,能力优秀=13%)。只有一半的受访者接受过伦理审查方面的培训。尽管大多数人认为伦理准则非常重要(66%),但在伦理准则的使用方面存在挑战,包括对伦理委员会国家认证机制缺乏认识(59%)。遵守伦理原则和规定受到以下因素影响:是科学家(比值比=42.47)、是专业组织的员工(比值比=15.25)以及对伦理准则的使用感兴趣(比值比=10.85)。这些发现表明需要加强能力建设(通过培训和资源支持),在研究伦理委员会中增加女性代表以及其他必需的专业人员。

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