Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension
Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension
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DOI：
10.1136/medethics-2012-101115
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发表时间：
2014-04-01
影响因子：
4.1
通讯作者：
Reichlin, Massimo
中科院分区：
文献类型：
--
作者：
Sanchini, Virginia;Reni, Michele;Reichlin, Massimo
我们探索了77名癌症患者对知情同意的理解，这些患者之前在2011年3月至7月期间在米兰的San Raffaele科学研究所参加了随机II期或III期临床试验。我们要求参与者完成一份特别问卷，并分析他们的答案。62%的患者了解他们参与的试验的目的和性质；44%的患者了解研究程序，40%的患者正确列出了至少一个与他们参与试验有关的主要风险或并发症。我们确定了与理解知情同意相关的三个因素：年龄、教育程度和肿瘤类型/研究团队。我们对如何获得知情同意提出了几点可能的改进，这将提高患者的意识，以及临床试验的有效性和有效性。
We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.