The informed consent process in a cross-cultural setting: is the process achieving the intended result?

This report is based on the experiences of Navajo interpreters working in a diabetes clinical trial and describes the problems encountered in translating the standard research consent across cultural and linguistic barriers. The interpreters and a Navajo language consultant developed a translation of the standard consent form, maintaining the sequence of information and exactly translating English words and phrases. After four months of using the translated consent, the interpreters met with the language expert and a diabetes expert to review their experiences in presenting the translation in the initial phases of recruitment. Their experiences suggest that the consent process often leads to embarrassment, confusion, and misperceptions that promoted mistrust. The formal processes that have been mandated to protect human subjects may create barriers to research in cross-cultural settings and may discourage participation unless sufficient attention is given to ensuring that both translations and cross-cultural communications are effective.