Zielinski Chris, Kebede Derege, Mbondji Peter Ebongue, Sanou Issa, Kouvividila Wenceslas, Lusamba-Dikassa Paul-Samson
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.
J R Soc Med. 2014 May;107(1 suppl):70-76. doi: 10.1177/0141076813517679. Epub 2014 Mar 18.
To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries.
A structured questionnaire was used to solicit information on research ethics from health research institutions.
Forty-two sub-Saharan African countries.
Key informants from the health research institutions.
Existence of institutional ethics review policies and mechanisms.
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.
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.
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。
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。
42个撒哈拉以南非洲国家。
卫生研究机构的关键信息提供者。
机构伦理审查政策和机制的存在情况。
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。
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。