Informed consent in clinical trials means different things to different people. Sometimes it means consent is given with full knowledge, and sometimes it just seems that way.
Nearly half of all U.S.-based clinical trials are now conducted overseas―many in countries where the native language is not English, where literacy in local languages is low, and health literacy is even lower.
Informed consent forms for international research are generally written first in English and then translated into the local language. In the latest IRB: Ethics & Human Research, researchers Caroline Lithinji and Nancy Kass question the assumption that if an English language consent form is simplified, then the translated version will resemble the original form in its readability.
‘The Kenya Medical Research National Ethical Review Committee determines readability of English consent forms before translation; however, it is neither their policy nor practice to determine whether the forms, once translated into Kiswahili, are of comparable readability to the English forms.”
Turns out they aren’t. The two did a study to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili.
The authors used a readability formula called the cloze procedure, which measures a reader’s ability to make sense of the text.
Cloze procedure is a technique in which words are deleted from a passage according to a word-count formula or various other criteria. The passages are presented to students, who insert words as they read to complete and construct meaning from the text. Cloze tests require the ability to understand context and vocabulary in order to identify the correct words or type of words that belong in the deleted passages of a text. This exercise is commonly administered for the assessment of native and second language learning and instruction.
For the study, volunteers in Kenya read 10 consent forms written in simplified English and the same forms translated into Kiswahili—which, with English, is one of the two official languages of Kenya. Seven out of 10 translated versions had a significant mean difference, suggesting they were less comprehensible in Kiswahili than in English. Using a “cloze pass mark” as a score of above 38 percent, for six of the 10 forms a greater percentage of respondents “failed” the Kiswahili form than the English version.
The findings raise questions about the quality of the translations of consent forms used in clinical trials. “Ethics review committees should pause before asking only for simplified English language forms without scrutinizing the language or translation approach that will be used to translate those forms into the local language,” the authors wrote.
It’s hard to see the rationale behind this practice, other than the ease and convenience of the review board. It really doesn’t have much to do with what the participants may be experiencing. Once you run out of excuses, limited English proficient, limited native-language proficiency, limited literacy, limited health literacy… what’s left? Is the participant still competent to participate? Well, look, they signed right here…