Jhanwar Venu Gopal, Bishnoi Ram Jeevan
Deva Institute of Healthcare and Research (P) Ltd, B27/70MN, Durgakund, Varanasi - 221005, India.
Indian J Psychol Med. 2010 Jan;32(1):7-12. doi: 10.4103/0253-7176.70517.
Informed consent forms are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average subject actually understands of the information contained in these informed consent forms is uncertain.
In a cross sectional study, the translated informed consent forms used in psychiatric clinical trials were assessed with respect to their ease of readability.
We analyzed 30 informed consent forms translated from English to Hindi used in multinational and multicentre psychiatric clinical trials sponsored by different sponsors. We examined consent forms for readability scores and factors that might relate to readability.
The mean readability score for the informed consent forms, determined by the Flesch-Kincaid Grade Level Index (FKGL) was grade levels of 13.66. The ease of readability assessed by the Flesch Reading Ease Score (FRES) was 46.08 suggesting significant complexity of the texts. These values carry even more significance when the average years of schooling for India as a whole are 6.2 years.
Our results show that the most informed consent forms were too complex to understand by an average adult subject. We suggest reducing this complexity and increasing the ease of readability so those average subjects receive the intended information as exactly as it could be. This can be achieved by few simple measures like improving the deficiencies in translation processes, encouraging the investigators to participate while preparing these forms, and enhanced understanding of the site specific requirements, namely culture, language (dialect), general literacy rate, etc.
所有临床试验在实际用于试验之前都需经独立伦理委员会批准，并要有知情同意书。然而，普通受试者对这些知情同意书中所包含信息的实际理解程度尚不确定。
在一项横断面研究中，对精神科临床试验中使用的翻译后的知情同意书的易读性进行评估。
我们分析了30份从英文翻译成印地语的知情同意书，这些知情同意书用于由不同主办方赞助的跨国和多中心精神科临床试验。我们检查了知情同意书的可读性得分以及可能与可读性相关的因素。
根据弗莱什-金凯德年级水平指数（FKGL）确定的知情同意书的平均可读性得分为13.66年级水平。通过弗莱什阅读简易度得分（FRES）评估的易读性为46.08，表明文本具有显著的复杂性。考虑到印度全国的平均受教育年限为6.2年，这些数值更具意义。
我们的结果表明，大多数知情同意书对于普通成年受试者来说过于复杂而难以理解。我们建议降低这种复杂性并提高易读性，以便普通受试者能够准确接收预期的信息。这可以通过一些简单的措施来实现，比如改善翻译过程中的不足，鼓励研究者在准备这些表格时参与其中，以及增强对特定地点要求的理解，即文化、语言（方言）、总体识字率等。
