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发展中国家的研究伦理委员会与知情同意:以土耳其为例

Research ethics committees in developing countries and informed consent: with special reference to Turkey.

作者信息

Oguz N Yasemin

机构信息

Department of Medical Ethics, Ankara University Faculty of Medicine, Turkey.

出版信息

J Lab Clin Med. 2003 May;141(5):292-6. doi: 10.1016/S0022-2143(03)00037-4.

DOI:10.1016/S0022-2143(03)00037-4
PMID:12761472
Abstract

Research ethics committees (RECs) are the institutional equivalent of institutional review boards (IRBs) with respect to their role in the ethical analysis of research projects. In Turkey, as in most developing countries, these committees were initiated as a result of pressure from the Western scientific community. Since their formation, RECs have faced problems because of an underdeveloped scientific culture and the absence of established ethical standards. On the one hand, the standards of the RECs and IRBs in the developed world seemed too hard to achieve; on the other, some of the international regulatory rules, such as respect for autonomy, are not culturally sensitive. In addition to problems facing RECs, researchers have had difficulties in fulfilling RECs' requisites. Respect for autonomy is a good example for Turkey. The social construct of Turkish society is not based on the Western concept of autonomy; it is based on "collective autonomy," which is completely different from the Western definition. Cultural interpretation of concepts is the perception of concepts effected by their cultural connections with other concepts. For example, "motherhood" as a concept has many cultural connections, so when it is used we have to consider those culturally determined contexts. In some countries, the familiar concept and term are kept separated from the one that is imported. In others, the imported concept alters the original concepts content. Although its course varies in different countries, it always puts extraordinary pressure on RECs and researchers in their relationship between themselves and other parties with conflicting interests. In this article, some of the main concerns of RECs in developing countries are discussed, with special reference to Turkey. The universality of regulatory norms is questioned and the importance of culturally sensitive and effective safeguards emphasized.

摘要

研究伦理委员会(RECs)在研究项目的伦理分析中所起的作用,相当于机构审查委员会(IRBs)。在土耳其,与大多数发展中国家一样,这些委员会是在西方科学界的压力下设立的。自成立以来,由于科学文化不发达以及缺乏既定的伦理标准,研究伦理委员会面临诸多问题。一方面,发达国家的研究伦理委员会和机构审查委员会的标准似乎难以企及;另一方面,一些国际监管规则,如对自主性的尊重,在文化上缺乏敏感性。除了研究伦理委员会面临的问题外,研究人员在满足研究伦理委员会的要求方面也存在困难。对土耳其来说,尊重自主性就是一个很好的例子。土耳其社会的社会结构并非基于西方的自主性概念;它基于“集体自主性”,这与西方的定义完全不同。概念的文化解读是指概念受其与其他概念的文化联系影响而产生的认知。例如,“母性”作为一个概念有许多文化联系,所以当使用这个概念时,我们必须考虑那些由文化决定的背景。在一些国家,熟悉的概念和术语与引入的概念是分开的。在另一些国家,引入的概念会改变原有概念的内容。尽管其过程在不同国家有所不同,但它总是给研究伦理委员会和研究人员在与其他利益冲突方的关系中带来巨大压力。在本文中,将讨论发展中国家研究伦理委员会的一些主要关切问题,特别提及土耳其。对监管规范的普遍性提出质疑,并强调文化敏感且有效的保障措施的重要性。

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