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Overview of national health research systems in sub-Saharan Africa: results of a questionnaire-based survey.撒哈拉以南非洲国家卫生研究系统概述:基于问卷调查的结果
J R Soc Med. 2014 May;107(1 suppl):46-54. doi: 10.1177/0141076814530600. Epub 2014 Jun 9.
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Surveying the knowledge landscape in sub-Saharan Africa: methodology.审视撒哈拉以南非洲地区的知识版图:方法学
J R Soc Med. 2014 May;107(1 suppl):13-21. doi: 10.1177/0141076814531411. Epub 2014 Jun 9.
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Outcome of a research ethics training workshop among clinicians and scientists in a Nigerian university.尼日利亚一所大学的临床医生和科学家参加研究伦理培训研讨会的成果。
BMC Med Ethics. 2008 Jan 24;9:1. doi: 10.1186/1472-6939-9-1.
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Assessment of the ethical review process in Sudan.苏丹伦理审查过程评估
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Health Research Ethics Committees in South Africa 12 years into democracy.南非民主制度建立12年后的健康研究伦理委员会。
BMC Med Ethics. 2007 Jan 25;8:1. doi: 10.1186/1472-6939-8-1.
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The structure and function of research ethics committees in Africa: a case study.非洲研究伦理委员会的结构与功能:一项案例研究
PLoS Med. 2007 Jan;4(1):e3. doi: 10.1371/journal.pmed.0040003.
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Status of national health research systems in ten countries of the WHO African Region.世界卫生组织非洲区域十个国家的国家卫生研究系统状况。
BMC Health Serv Res. 2006 Oct 19;6:135. doi: 10.1186/1472-6963-6-135.
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Resource and needs of research ethics committees in Africa: preparations for HIV vaccine trials.非洲研究伦理委员会的资源与需求:为艾滋病毒疫苗试验做准备
IRB. 2006 Mar-Apr;28(2):1-9.
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Status of national research bioethics committees in the WHO African region.世界卫生组织非洲区域国家研究伦理委员会的现状
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撒哈拉以南非洲国家卫生研究机构的研究伦理政策与实践:一项基于问卷调查的结果

Research ethics policies and practices in health research institutions in sub-Saharan African countries: results of a questionnaire-based survey.

作者信息

Zielinski Chris, Kebede Derege, Mbondji Peter Ebongue, Sanou Issa, Kouvividila Wenceslas, Lusamba-Dikassa Paul-Samson

机构信息

World Health Organization Regional Office for Africa, PO Box 6, Brazzaville, Republic of Congo

World Health Organization Regional Office for Africa, PO Box 6, Brazzaville, Republic of Congo.

出版信息

J R Soc Med. 2014 May;107(1 suppl):70-76. doi: 10.1177/0141076813517679. Epub 2014 Mar 18.

DOI:10.1177/0141076813517679
PMID:24643663
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4109349/
Abstract

OBJECTIVE

To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries.

DESIGN

A structured questionnaire was used to solicit information on research ethics from health research institutions.

SETTING

Forty-two sub-Saharan African countries.

PARTICIPANTS

Key informants from the health research institutions.

MAIN OUTCOME MEASURES

Existence of institutional ethics review policies and mechanisms.

RESULTS

About half (51%) of respondent institutions reported having policies on research ethics and 58% had written policies requiring that researchers obtain informed consent of research participants. About one-third of respondent institutions (34%) had established ethics review committees, 42% required that studies went through ethics review committees and 46% had linkages with national or regional ethics organisations. Regarding operating procedures for ethics review committees, 53% had adopted standard operating procedures. Less than one-quarter of respondent institutions reported having policies in place to monitor ongoing research. Of the institutions that monitored ongoing research, 34% did an annual ethical review and 74% required a periodic written report. Only 36% provided any type of ethics training for staff, including those conducting health research and those who were not members of the ethics review committee.

CONCLUSIONS

There are substantial gaps in the capacity of health research institutions in the WHO African Region to undertake ethical review of studies before, during and after studies conducted. There is a need to strengthen such capacity in order to ensure the wellbeing of individuals enrolled in studies and that of communities that host these studies.

摘要

目的

描述撒哈拉以南非洲国家卫生研究机构的研究伦理政策与实践状况。

设计

采用结构化问卷从卫生研究机构收集有关研究伦理的信息。

背景

42个撒哈拉以南非洲国家。

参与者

卫生研究机构的关键信息提供者。

主要观察指标

机构伦理审查政策和机制的存在情况。

结果

约一半(51%)的受访机构报告有研究伦理政策,58%有书面政策要求研究人员获得研究参与者的知情同意。约三分之一(34%)的受访机构设立了伦理审查委员会,42%要求研究须经过伦理审查委员会,46%与国家或地区伦理组织有联系。关于伦理审查委员会的运作程序,53%采用了标准操作程序。不到四分之一的受访机构报告有监测正在进行的研究的政策。在监测正在进行的研究的机构中,34%进行年度伦理审查,74%要求定期提交书面报告。只有36%为工作人员提供了任何类型的伦理培训,包括从事卫生研究的人员和非伦理审查委员会成员的人员。

结论

世卫组织非洲区域卫生研究机构在对研究进行研究前、研究期间和研究后的伦理审查方面的能力存在很大差距。需要加强这种能力,以确保参与研究的个人以及开展这些研究的社区的福祉。