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引用次数: 2
摘要
本文讨论了1996年辉瑞公司在尼日利亚卡诺进行的有争议的Trovan研究,研究人员应该考虑的特殊社会文化因素,以及2007年国家卫生研究伦理准则在强制研究人员遵守知情同意过程中的伦理标准方面的相关性。研究人员被期望对那些他们邀请参与的人的许多可利用的弱点来源保持敏感。由于没有注意到影响尼日利亚知情同意过程的特殊社会文化因素,可能导致许多调查人员未能适用和遵守有关的地方和国际研究条例。真正尊重人的尊严需要更深入地了解患者的价值观、文化、家庭和社区。尼日利亚在语言、宗教、经济和传统方面具有社会文化多样性。研究者需要充分熟悉当地的社会文化特征,以便有意义地传达自由和知情同意所依据的研究目的和方法。知情同意在社会行为和健康相关研究中的中心地位怎么强调都不过分。在非西方人群的人类研究中,与指定的权威机构协商知情同意要求研究者超越对人格、自主性和“自我”决定的狭隘定义。没有这些,研究人员的努力将仅仅是对人类同胞的剥削和虐待。关键词:关键词;关键字;非洲社会问题心理研究杂志Vol. 11 (1&2) 2008: pp. 228-237
Socio-Cultural Factors Influencing Consent For Research In Nigeria: Lessons From Pfizer's Trovan Clinical Trial
This paper discusses the controversial Trovan study conducted by Pfizer in 1996 in Kano, Nigeria, the peculiar socio-cultural factors that researchers should consider as well as the relevance of the 2007 National Code for Health Research Ethics in enforcing researchers' compliance with ethical standards in informed consent process. Researchers are expected to be sensitive to the many sources of exploitable vulnerability in those whose participation they invite. The failure to give attention to peculiar socio-cultural factors influencing the process of informed consent in Nigeria might have contributed to the failure of many investigators to apply and conform to related local and international research regulations. Genuine respect for human dignity requires deeper understanding of patients' values, culture, family and community. Nigeria is socio-culturally diverse in terms of language, religion, economy, and traditions. Investigators require adequate familiarity with the local socio-cultural characteristics in order to meaningfully communicate the research purpose and method upon which free and informed consent is based. The centrality of informed consent in socio-behavioural and health related researches can not be over emphasized. Negotiating informed consent with the designated authorities in human research with non-Western populations requires investigators to move beyond narrow definitions of personhood, autonomy, and “self” determination. Without these, researchers' efforts would be mere exploitation and abuse of fellow human beings. Keywords : keyword; keyword; keyword African Journal for the Psychological Study of Social Issues Vol. 11 (1&2) 2008: pp. 228-237