Ethical review of health research: a perspective from developing country researchers
Ethical review of health research: a perspective from developing country researchers
复制标题
DOI：
10.1136/jme.2002.001933
复制
发表时间：
2004-02-01
影响因子：
4.1
通讯作者：
Dawson, L
中科院分区：
文献类型：
--
作者：
Hyder, AA;Wali, SA;Dawson, L
背景：工业化国家和发展中国家在人类研究方面日益加强的合作引起了对资源匮乏国家可能被剥削的关注。这项由前美国国家生物伦理咨询委员会委托进行的研究调查了发展中国家的科学家，了解他们对伦理审查过程以及发展中国家和美国国际审查委员会（irb）的表现的关注和意见。方法：使用来自四个国际组织的联系人名单来确定和调查发展中国家的670名卫生研究人员。一份包含169个问题的调查问卷探讨了IRB审查、知情同意和建议等问题。结果：大多数发展中国家的研究人员是中年男性，他们是医生，受雇于教育机构，从事兼职研究。44%的答复者报告说，他们的研究没有得到发展中国家伦理委员会或卫生部的审查，其中三分之一的研究由美国资助。在审查过程中，美国内部审查委员会提出的问题，如需要当地语言的同意书和批准信，以及参与者的保密保护，比例明显高于东道国内部审查委员会。结论：这项调查表明，美国和东道国都需要对合作研究进行伦理审查。它还反映了在支持研究伦理审查方面有重点的能力发展的愿望。
Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards ( IRBs).Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.