Department of Human Biology, Faculty of Health Sciences, University of Abomey-Calavi, Cotonou, Benin.
National Ethics Committee for Health Research, Ministry of Health, Cotonou, Benin.
BMC Med Ethics. 2022 Nov 19;23(1):116. doi: 10.1186/s12910-022-00857-x.
Ethics in biomedical research is still a fairly new concept in Africa. This work aims to assess the knowledge, attitude and experiences of Beninese researchers with regard to the national ethical regulatory framework of biomedical research in Benin.
This was a cross-sectional and descriptive study, involving all the researchers fulfilling the inclusion criteria. Data were collected through a face-to-face interview using a questionnaire and analysed. Proportions and means were calculated with their confidence intervals and standard deviations, respectively.
Of the 110 participants included in the study, 40.9% were medical lecturers and 71.1% had been involved in more than 10 biomedical research as researcher. Less than three quarters (69.1%) were able to correctly quote the basic principles from Belmont report. The quarter (25.45%) of them knew the attributions of the National Ethics Committee for Health Research (CNERS in French) and 38.2%, the content of the legislation on health research ethics in Benin. The common ethical rules were known by 69.1% of the participants. A quarter (25.5%) of participants said they always present the study's briefing note to their study participants and 62.7% said they systematically request informed consent. For those who do not present the briefing note to participants, the main reasons provided were the researchers' difficulties in writing the note in plain language and the participants' limitation in understanding it.
The foundations of a good ethical framework for health research exist in Benin. However, the deployment and use of the various legal texts deserve to be improved.
在非洲，生物医学研究中的伦理学仍然是一个相当新的概念。这项工作旨在评估贝宁研究人员对贝宁生物医学研究国家伦理监管框架的知识、态度和经验。
这是一项横断面和描述性研究，涉及所有符合纳入标准的研究人员。通过使用问卷进行面对面访谈收集数据，并进行分析。分别计算了比例和平均值及其置信区间和标准偏差。
在纳入研究的 110 名参与者中，40.9%是医学讲师，71.1%作为研究人员参与了超过 10 项生物医学研究。不到四分之三（69.1%）的人能够正确引用贝尔蒙报告的基本原则。其中四分之一（25.45%）的人知道国家卫生研究伦理委员会（CNERS 用法语）的职责，38.2%的人知道贝宁卫生研究伦理立法的内容。69.1%的参与者知道常见的伦理规则。四分之一（25.5%）的参与者表示他们总是向研究参与者提交研究简报说明，62.7%的参与者表示他们系统地要求知情同意。对于那些不向参与者提交简报说明的人，主要原因是研究人员难以用通俗易懂的语言编写说明，以及参与者理解说明的局限性。
贝宁已经为健康研究制定了良好的伦理框架的基础。然而，各种法律文本的部署和使用还有待改进。
