Department of Pharmacology, Postgraduate Institute of Medical & Research, Chandigarh 160012, India.
Contemp Clin Trials. 2009 Sep;30(5):427-30. doi: 10.1016/j.cct.2009.03.005. Epub 2009 Mar 31.
The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials.
Patients who were invited to participate in a phase 3 multicentric trial of a novel lipid lowering agent were evaluated for comprehension score. The participants were explained about the structured consent form which included the question on background details for the study, design of the study, rights of the patients and miscellaneous aspects pertinent to the clinical trial. The questionnaire comprised of 24 items and each correct answer was assigned a score of 1. Total comprehension score (CS) was obtained by summing all the scores.
Participants were from diverse socio economic and educational backgrounds. The mean +/- SD CS achieved by the participants was 13.4 +/- 2.9; median 14(6 to 20). The highest correct responses were obtained for questions on background details (38%). For most of the categories the mean CS was more than 50%. Aspects related to design were mostly difficult to comprehend. No significant difference in the CS was noted between participants from different educational and socioeconomic groups. 8 patients refused to give consent, fear of adverse drug reactions (n = 3) and inability to follow up (n = 5) were the reasons cited by the patients.
In conclusion, CS of patients in trials conducted in developing countries can be reasonably good if the investigators explain the consent form in simple language to the participants and CS is not related to the educational status of the participants. Moreover, though a larger majority of patients agree to participate after knowing study details, some patients exercise their right to refuse.
知情同意书的理解是临床试验的一个组成部分。尽管印度正在迅速成为临床试验的中心，但很少有研究涉及参与这些试验的患者对知情同意书的理解问题。
邀请参加一项新型降脂药物的 3 期多中心试验的患者评估其理解得分。向参与者解释了结构化同意书，其中包括研究背景、研究设计、患者权利和与临床试验相关的其他方面的问题。问卷由 24 个问题组成，每个正确答案得 1 分。通过将所有分数相加得出总理解分数 (CS)。
参与者来自不同的社会经济和教育背景。参与者的平均 +/- SD CS 得分为 13.4 +/- 2.9；中位数 14（6 到 20）。对于背景细节问题，参与者的正确回答最多（38%）。对于大多数类别，平均 CS 均超过 50%。与设计相关的方面最难理解。来自不同教育和社会经济群体的参与者之间的 CS 没有显著差异。有 8 名患者拒绝同意，患者提到的原因是担心药物不良反应（n=3）和无法随访（n=5）。
总之，如果研究人员用简单的语言向参与者解释同意书，并且 CS 与参与者的教育程度无关，那么在发展中国家进行的试验中，患者的 CS 可以相当好。此外，尽管大多数患者在了解研究细节后同意参与，但有些患者行使了拒绝的权利。
