Why do individuals agree to enrol in clinical trials? A qualitative study of health research participation in Blantyre, Malawi
Why do individuals agree to enrol in clinical trials? A qualitative study of health research participation in Blantyre, Malawi
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DOI：
10.4314/mmj.v20i2.10898
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发表时间：
2008-06-01
影响因子：
0.8
通讯作者：
Molyneux, Malcolm
中科院分区：
文献类型：
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作者：
Mfutso-Bengo, Joseph;Ndebele, Paul;Molyneux, Malcolm
目前的文献表明，治疗误解（临床试验参与者认为他们实际上只是在接受临床护理）很常见，尤其是在发展中国家的文盲人群中。治疗误解反映了知情同意方面的问题，因为人们同意参加临床试验，但没有意识到试验程序和测试产品实际上可能对他们没有好处。在这项针对前几年参加过各种研究项目的马拉维成年人的研究中，我们发现大多数人参加研究是为了获得通过临床试验作为辅助护理提供的更优质的治疗。他们同意参加并不是因为相信试验的实际程序将直接有益于他们的健康。受访者表示，由于政府医院人满为患且普遍缺乏药品，他们同意参加研究项目，希望获得临床试验提供的辅助护理。我们的结论是，在这种环境下，可能由于常规医疗服务不足，人们会做出参与研究的理性决定。我们质疑“治疗误解”一词是否准确地描述了参与者在资源有限的情况下的动机。我们还讨论了这些发现对于理解临床试验中不当诱导的相关性。
Current literature suggests that therapeutic misconception - a belief by participants in a clinical trial that they are in fact simply being given clinical care - is common, especially among illiterate populations in developing countries. Therapeutic misconception reflects problems in informed consent, as people agree to participate in clinical trials without being aware that the trial procedures and test products may not in fact benefit them.In this study of Malawian adults who had participated in research projects of various kinds during the preceding years, we found that the majority participated in research for the sake of obtaining better quality treatment made available through the clinical trials as ancillary care. Their consent to participate was not due to a belief that the actual procedures of the trial would directly benefit their health. Respondents indicated that, government hospitals being crowded and commonly lacking drugs, they agreed to take part in research projects in the hope of obtaining access to ancillary care provided by clinical trials.We conclude that in this environment, possibly owing to inadequacy of routine health services, people make rational decisions to participate in research. We question whether the term 'therapeutic misconception' accurately describes participants' motivation under conditions of limited resources. We also discuss the relevance of these findings for understanding undue inducement in clinical trials.