Comprehensibility of Translated Informed Consent Documents Used in Clinical Research in Psychiatry

Abstract

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.