Clinical trials abroad: Making non-English language consent forms readable

Aug 10, 2010

The first study to look at simplified English-language consent forms translated into another language calls into question the common belief that a translated consent form meets readability standards. The study appears in IRB: Ethics & Human Research.

Nearly half of all U.S.-based are now conducted overseas, many in countries where the native language is not English and whose population has low literacy - factors that present challenges to getting informed consent. But ethics review committees around the world generally assume that if an English language consent form is simplified, then the translated version will resemble the original form in its readability.

The authors used a readability formula called the cloze procedure, which measures a reader's ability to make sense of the text. 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 Kiswahil 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 forms without scrutinizing the language or translation approach that will be used to translate those forms into the local language," the authors wrote.

Explore further: Support for electronic health information varies with use

Provided by The Hastings Center

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

Consent forms for research: Have they improved in 25 years?

May 28, 2010

The consent forms that people sign before participating in research are widely considered difficult to understand and sometimes inaccurate. The lack of clarity was implicated in a high-profile legal settlement in April between ...

Second language learners recall native language when reading

Jun 01, 2010

(PhysOrg.com) -- Adults fluent in English whose first language is Chinese retrieve their native language when reading in English, according to new research in the June 2 issue of The Journal of Neuroscience. This study sugges ...

Instant messaging -- a new language?

May 01, 2008

For many adults over the age of 30, the former groupings of letters would seem incoherent, but for a newer generation of technologically-savvy young adults it can say a lot.

Patient consent forms should educate not intimidate

Dec 17, 2008

It's time patient consent forms came back full circle to a tool for patient education, rather than the waiver of liability they have become. The original purpose of the consent forms was for a surgeon or doctor to inform ...

The language of luxury

Sep 17, 2008

Virtually every population in the world has at least one thing in common: multinational companies are vying for their attention. From General Mills in India to Godiva Chocolate in Paraguay, advertising is one of the most ...

Recommended for you

Supplement maker admits lying about ingredients

11 hours ago

Federal prosecutors say the owner and president of a dietary supplement company has admitted his role in the sale of diluted and adulterated dietary ingredients and supplements sold by his company.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.