Criscione Lisa G, Sugarman Jeremy, Sanders Linda, Pisetsky David S, St Clair E William
Duke University Medical Center, Durham, North Carolina 27710, USA.
Arthritis Rheum. 2003 Jun 15;49(3):361-7. doi: 10.1002/art.11057.
To evaluate the informed consent process for a clinical trial of intravenous doxycycline for rheumatoid arthritis.
Participants completed a self-administered questionnaire about the consent process at baseline and 16 weeks following enrollment in a clinical trial.
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.
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.
评估静脉注射强力霉素治疗类风湿性关节炎临床试验的知情同意过程。
参与者在临床试验入组时及入组后16周完成一份关于同意过程的自填式问卷。
受访者（n = 30）确认自愿参与母试验。参与者认为希望和利他主义是参加试验的原因，而非期望个人受益或外部影响。许多受访者不理解随机分组（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完全安全。
受访者普遍理解试验的实验性质，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，这引发了一个问题，即他们在入组前是否得到了关于该研究的充分信息。可能需要对临床试验的潜在参与者进行进一步教育，以获得有效的知情同意。
