Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis
Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis
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DOI：
10.1002/art.11057
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发表时间：
2003-06-15
期刊：
影响因子：
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通讯作者：
St Clair, EW
中科院分区：
文献类型：
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作者：
Criscione, LG;Sugarman, J;St Clair, EW
目标。目的评价静脉注射多西环素治疗类风湿性关节炎临床试验的知情同意程序。参与者完成了一份关于同意过程的自填式问卷，在基线和登记参加临床试验的16周后。受访者(n=30)确认自愿参加父母试验。参与者承认希望和利他主义是进入试验的原因，而不是对个人利益或外部影响的期望。许多受访者不了解随机(14/30)、安慰剂(15/30)或研究药物的风险；11/30的受访者认为研究药物是完全安全的。受访者普遍理解试验的试验性，并确认他们的参与是自愿的。然而，参与者对试验设计的理解存在差距，这引发了他们在登记之前是否对研究研究有充分了解的问题。可能需要对临床试验的潜在参与者进行进一步教育，以实现有效的知情同意。
Objective. To evaluate the informed consent process for a clinical trial of intravenous doxycycline for rheumatoid arthritis.Methods. Participants completed a self-administered questionnaire about the consent process at baseline and 16 weeks following enrollment in a clinical trial.Results. Respondents (n = 30) affirmed voluntary participation in the parent trial. Participants acknowledged hope and altruism as reasons for entering the trial more than expectation of personal benefit or outside influences. Many respondents did not understand randomization (14/30), placebos (15/30), or risks of study medications; 11/30 respondents believed that the study drug was completely safe.Conclusion. Respondents generally understood the experimental nature of the trial and confirmed their participation was voluntary. However, gaps existed in participants understanding of trial design, raising the question of whether they were adequately informed about the research study prior to enrollment. Further education of potential participants in clinical trials may be required to achieve valid informed consent.