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Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

机译:人体研究中的知情同意:当前国际和尼日利亚指南的比较。

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Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.
机译:知情同意是涉及人类受试者的道德研究的基本要求。当前,世界医学协会的《赫尔辛基宣言》和国际医学科学组织理事会(CIOMS)的《生物医学研究国际伦理准则》已被广泛接受,成为规范人类受试者研究的国际法规,并且这些文件的知情同意部分相当重要。关于这些准则在不同社会文化背景下的适用性的辩论仍在进行中,许多工人主张需要国家或地区准则。发展中国家尼日利亚最近通过了规范人体研究的国家指南:国家健康研究伦理委员会(NHREC)守则。对这三个指南进行了内容分析,以查看尼日利亚指南是否赋予研究对象任何额外的保护。尼日利亚指南中的社区咨询委员会的概念是一个新颖的概念,它强调研究是社区的负担,应促进一种“研究友谊”的形式,以促进研究参与者的福利。还需要定期更新NHREC代码,以解决当前版本中未考虑的一些问题。

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