Byline: Venu. Jhanwar, Ram. Bishnoi
Background: 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. Aim: In a cross sectional study, the translated informed consent forms used in psychiatric clinical trials were assessed with respect to their ease of readability. Materials and Methods: 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. Results: 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. Conclusion: 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.
There is a consensus regarding the importance of informed consent in clinical research. The process of obtaining informed consent from subjects is a critical point of entry for research participants. [sup] Patients learn about clinical trials from numerous ways and also there are several factors affecting their decision-making capacity. Educational materials for patients and informed-consent documents present highly complex information that must be understood by patients. [sup], Kuczewski and Marshall [sup] recommend adopting the approach that consent is an interactive and dynamic process and many factors can influence the study participant's willingness to sign the document. These factors include socioeconomic background, cultural traditions, literacy and language ability, and interactions with physicians, and other healthcare professionals.
The manner and context in which information is conveyed is as important as the information itself. The ability to understand is dependent upon patients' intelligence, rationality, maturity, and language, and it is necessary to adopt the presentation of information in subject's capacity to understand. (Belmont report). [sup] The informed consent process presents some major challenges for study participants and research staff. Several researchers have addressed these problems with need to improve upon them. Among them, Brady [sup] identifies the following issues:
*Subject's hesitation to ask detailed questions *Variable presentation of the content *Difficulty verifying the subject's comprehension. A vital component of the informed consent process in participant's comprehension of the given information, without which it may not be completely "informed" consent. It becomes more so important when a literacy rate for adults over age of 15 years was 66% in India in 2007 (UNESCO Institute for Statistics). For males, it was 76.9% but only 54.5% females were literate. Average years of schooling have commonly been used as a proxy for educational attainment. The average years of schooling for India as a whole are 6.2 years (National Sample Survey Organisation). Sixteen of the 27 states have an average that is lower than the national average including the states of Uttar Pradesh and Bihar. …