加纳的知情同意：参与者真正理解了什么？

Informed consent in Ghana: what do participants really understand?

作者信息

Hill Z, Tawiah-Agyemang C, Odei-Danso S, Kirkwood B

机构信息

Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.

出版信息

J Med Ethics. 2008 Jan;34(1):48-53. doi: 10.1136/jme.2006.019059.

DOI:10.1136/jme.2006.019059

PMID:18156522

Abstract

OBJECTIVES

To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15-45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge.

METHODS

60 semistructured interviews and 12 focus groups were conducted to explore subjects' perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge that not all trial capsules are the same. The subjects' fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling.

RESULTS

Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers' characteristics were not associated with subjects' knowledge.

CONCLUSIONS

Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education.

摘要

目的

探讨在一项针对15至45岁加纳女性的安慰剂对照维生素A补充试验中，受试者如何看待该试验，以及她们是否知道并非所有试验胶囊都一样，并确定与这一认知相关的因素。

方法

进行了60次半结构式访谈和12次焦点小组讨论，以探究受试者对试验的看法。采取了措施来解决理解不足的问题，包括对现场工作人员进行再培训。随机选择1971名试验受试者进行一项调查，以测量她们关于并非所有试验胶囊都一样的认知。还对受试者的现场工作人员就其特征和试验知识进行了访谈。使用多层次模型探究与认知相关的因素。