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研究人员对在发展中国家获取知情同意书的看法。

The perspectives of researchers on obtaining informed consent in developing countries.

作者信息

Newton Sam K, Appiah-Poku John

机构信息

Kintampo Health Research Centre, Kintampo, Ghana.

出版信息

Dev World Bioeth. 2007 Apr;7(1):19-24. doi: 10.1111/j.1471-8847.2006.00147.x.

DOI:10.1111/j.1471-8847.2006.00147.x
PMID:17355328
Abstract

BACKGROUND

The doctrine of informed consent (IC) exists to protect individuals from exploitation or harm. This study into IC was carried out to investigate how different researchers perceived the process whereby researchers obtained consent. It also examined researchers' perspectives on what constituted IC, and how different settings influenced the process.

METHODS

The study recorded in-depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees.

RESULTS

Although the concept and application of the doctrine of IC should have been the same, irrespective of where the research was carried out, the process of obtaining it had to be different. The setting had to be taken into consideration and the autonomy of the subject had to be respected at all times. In areas of high illiteracy, and where understanding of the subject was likely to be a problem, there was an added responsibility placed on the researcher to devise innovative ways of carrying out the study, taking into consideration the peculiarities of the environment.

CONCLUSION

The ethical issues for IC were the same, irrespective of where the research was conducted. However, because the backgrounds, setting, and knowledge of populations differed, there was the need to be similarly sensitive in obtaining consent. The problems of obtaining genuine IC were not limited to developing countries.

摘要

背景

知情同意原则的存在是为了保护个人免受剥削或伤害。本项关于知情同意的研究旨在调查不同研究人员如何看待研究人员获取同意的过程。该研究还考察了研究人员对知情同意构成要素的看法,以及不同环境如何影响这一过程。

方法

该研究记录了对12位讲师和5名博士生的深度访谈,这些人在英国一所顶尖公共卫生学院开展了针对发展中国家的研究。采用了目的抽样和滚雪球抽样的方法来确定受访者。

结果

尽管无论研究在何处开展,知情同意原则的概念和应用都应相同,但获取知情同意的过程却必须有所不同。必须考虑研究环境,而且必须始终尊重受试者的自主权。在文盲率高且可能存在对研究主题理解问题的地区,研究人员有额外的责任去设计创新的研究方法,同时要考虑到当地环境的特殊性。

结论

无论研究在何处进行,知情同意的伦理问题都是相同的。然而,由于人群的背景、环境和知识存在差异,在获取同意时同样需要保持敏感。获取真正的知情同意的问题并不局限于发展中国家。

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