IMPORTANT NOTE: It is the responsibility of the examiner to assess the understanding of the subject`s consent information, including understanding that participation is voluntary and that the participant has the right to resign at any time during the study. If the examiner doubts that the subject doubts the understanding of consent, he or she should not include the subject in the study. The autonomy of the subject must not be compromised by a language barrier. The subjectivity of any analysis of translated documents is perhaps less a limitation than an inevitable, given the very subjectivity of the language. It also shows the importance of taking a thoughtful and rigorous approach in the development of translated materials, including, where possible, cognitive tests with native speakers. Extensive translations and testing can help ensure that consent documents are understandable and provide the essential material potential participants need to make informed decisions about research. Generally speaking, consent documents are often written in complex and technical language, and empirical analyses continue to highlight large limitations in technical understanding.5-16 As a means of addressing comprehension problems, some researchers have made considerable efforts to develop and test empirically simpler consent materials.17-24 Although these efforts are not able to resolve. all the problems of understanding, they are an important step towards improvement. 25 GTS is the leading service for public relations staff. Official translation of declarations of consent into Spanish and all languages. Thank you to our colleagues Martina Bresciani, Perla Nunes and Cecilia Plez for their instrumental role in translating our consent documents. We also thank Colin Halverson, Catherine Hammack and Zachary Lampron for their support. Our goal was to produce quality Spanish translations from three consent documents initially developed in English: a 6-page declaration of consent, explicitly designed to be very similar to biobank consent forms in real use, a simplified 3-page biobank declaration of consent and a 15-page consent quiz with accompanying explanations of the correct answers.
These three documents were developed empirically with previous objectives of authorization25 Informed consent should be collected and documented as follows: if the participant population does not include Anglophones or the clinical examiner, or if the BRI expects consent interviews to be conducted in a language other than English, the BRI should require that a translated consent document be prepared and guaranteed; that the translation is correct. . . .