Exploring the comprehensibility of the informed consent form for clinical trials from a contrastive perspective: textual analysis in Spanish and English

This article presents some of the results of an exploratory study that analysed the informed consent form for clinical trials in Spanish and English from a textual and contrastive perspective. It determines the form taken by this hybrid medical-legal genre in the two languages and considers its comprehensibility using Nord's (2012) functional model of translation-oriented text analysis. This study highlights the structural and terminological variability of the genre between languages, and even within the same language, identifying several comprehension difficulties that would prevent participants from fully exercising their right to self-determination and access to comprehensible information.