Diemert David J, Lobato Lucas, Styczynski Ashley, Zumer Maria, Soares Amanda, Gazzinelli Maria Flávia
Department of Microbiology, Immunology and Tropical Medicine, The George Washington University School of Medicine and Health Sciences Washington, DC, United States of America.
School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
PLoS Negl Trop Dis. 2017 Jan 23;11(1):e0005327. doi: 10.1371/journal.pntd.0005327. eCollection 2017 Jan.
Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants' understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there was no difference in the rate of correct answers between participants in Belo Horizonte and Washington, DC, there was a significant gap between participants at these two locations compared to Americaninhas (p = 0.0002 and p = 0.0001, respectively), which had a lower percentage of correct answers. Attitudes towards participating in the clinical trial also differed by site: while approximately 40% had doubts about participating in Washington, DC and Belo Horizonte, only 1.5% had concerns in Americaninhas. Finally, in Belo Horizonte and Washington, high percentages cited a desire to help others as motivation for participating, whereas in Americaninhas, the most common reason for participating was personal interest (p = 0.001). Understanding of information about a Phase 1 clinical trial of an experimental hookworm vaccine following informed consent was suboptimal, regardless of study site. Although overall there were no differences in knowledge between Brazil and the US, a lower level of understanding about the trial was seen in participants at the rural, resource-limited Brazilian site. These findings demonstrate the need for educational interventions directed at potential clinical trial participants, both in developing and developed countries, in order to improve understanding of the informed consent document.
无论研究环境如何，知情同意都是开展临床研究的主要伦理要求之一。由于发展中国家正规教育水平较低、对生物医学研究缺乏了解以及这些国家获得医疗服务的机会有限，知情同意过程的质量问题经常在提及发展中国家进行的临床试验时被描述。然而，很少有研究使用相同工具并在类似临床试验中直接比较发达国家和发展中国家知情同意过程的质量。本研究旨在比较在巴西和美国进行的一系列研究性钩虫疫苗临床试验中知情同意过程的质量。使用标准化问卷评估在巴西和美国健康成年人中进行的Na-GST-1/氢氧化铝钩虫疫苗一系列1期临床试验中知情同意过程的伦理质量。在巴西，试验在两个地点进行，一个在米纳斯吉拉斯州贝洛奥里藏特的钩虫非流行市区，另一个在资源有限的农村城镇阿梅里卡尼亚斯，均位于米纳斯吉拉斯州；美国的试验在华盛顿特区进行。在三个试验地点的每一个，在签署知情同意文件后进行了一项包含32个问题的调查；该调查评估了参与者对文件中呈现的研究信息的理解以及他们参与决定的自愿性。105名参与者完成了问卷：63名在阿梅里卡尼亚斯,18名在贝洛奥里藏特，24名在华盛顿特区。关于试验的总体知识并不理想：关于研究目的、方法、持续时间、权利以及潜在风险和益处的问题，正确答案的平均数量在阿梅里卡尼亚斯为45.6%，在贝洛奥里藏特为65.2%，在华盛顿特区为59.1%。尽管贝洛奥里藏特和华盛顿特区的参与者正确答案率没有差异，但与阿梅里卡尼亚斯相比，这两个地点的参与者之间存在显著差距（分别为p = 0.0002和p = 0.0001），阿梅里卡尼亚斯的正确答案百分比更低。参与临床试验的态度也因地点而异：虽然在华盛顿特区和贝洛奥里藏特约40%的人对参与试验有疑虑，但在阿梅里卡尼亚斯只有1.5%的人有顾虑。最后，在贝洛奥里藏特和华盛顿，很大比例的人表示希望帮助他人是参与的动机，而在阿梅里卡尼亚斯，参与的最常见原因是个人兴趣（p = 0.001）。无论研究地点如何，在签署知情同意书后，对实验性钩虫疫苗1期临床试验信息的理解都不理想。虽然总体而言巴西和美国在知识方面没有差异，但在巴西资源有限的农村地区的参与者对试验的理解水平较低。这些发现表明，无论是在发展中国家还是发达国家，都需要针对潜在的临床试验参与者进行教育干预，以提高对知情同意文件的理解。
