Adewale Babatunde, Schoeman Lizette, Roussouw Theresa
Nigerian Institute of Medical Research; Chief Research Fellow, Public Health Division, PMB 2013 Yaba, Lagos, Nigeria,.
Senior Lecturer, The University of Pretoria, Pretoria, South Africa,.
Indian J Med Ethics. 2015 Oct-Dec;12(4):196-8. doi: 10.20529/IJME.2015.053. Epub 2015 Aug 25.
Benchmarks of ethical research in developing countries stipulate collaborative partnership, which necessitates the involvement of research participants and taking cognizance of their opinions in decisions regarding research activities. Little data regarding participants' perceptions about research activities exists in the developing world. This study assessed the knowledge and perceptions of research participants in Nigeria about clinical trials. A validated semi-structured questionnaire was used in a cross-sectional survey. Data were analysed using SPSS version 17. Seventy-five respondents (70.7% females, 29.3% males) with a mean age of 36.5±10.3 years, enrolled in an efficacy and safety study of Artequin in Ikorodu LGA, Nigeria, participated in the survey. Most of them (64%) had secondary education while 6.7% were illiterate. Only 5 (6.7%) had previously participated in a clinical trial. The majority of respondents (70.7%) did not know how medicines are determined to be safe and none knew how new drugs are tested. While only 10(13.3%) respondents felt that people were well treated during clinical trials, only two knew of someone who had been harmed because of participation and only one respondent could report on the type of harm experienced by the participant. The majority (86.7%) did not know if people were well treated or abused or whether people's rights were protected during clinical trials (84%). Despite being enrolled in a clinical trial, participants have limited knowledge about such trials. This lack of knowledge might impact the quality of informed consent provided. If true collaboration is to be achieved in developing world settings, the community in general, and trial participants in particular, should be educated about the basic principles of research.
发展中国家伦理研究的基准规定了合作关系，这就需要研究参与者的参与，并在有关研究活动的决策中考虑他们的意见。在发展中世界，关于参与者对研究活动看法的数据很少。本研究评估了尼日利亚研究参与者对临床试验的了解和看法。在一项横断面调查中使用了经过验证的半结构化问卷。数据使用SPSS 17版进行分析。75名受访者（70.7%为女性，29.3%为男性）参与了调查，他们的平均年龄为36.5±10.3岁，参加了尼日利亚伊科罗杜地方政府辖区的青蒿琥酯片有效性和安全性研究。他们中的大多数人（64%）接受过中等教育，而6.7%为文盲。只有5人（6.7%）曾参与过临床试验。大多数受访者（70.7%）不知道药物是如何确定为安全的，也没有人知道新药是如何测试的。虽然只有10名（13.3%）受访者认为人们在临床试验中得到了良好的治疗，但只有两人知道有人因参与试验而受到伤害，只有一名受访者能够报告参与者所经历的伤害类型。大多数人（86.7%）不知道人们在临床试验中是否得到了良好的治疗或受到了虐待，也不知道人们的权利是否得到了保护（84%）。尽管参与了临床试验，但参与者对这类试验的了解有限。这种知识的缺乏可能会影响所提供的知情同意书的质量。如果要在发展中世界实现真正的合作，一般社区，特别是试验参与者，应该接受有关研究基本原则的教育。
