Clinical trials are increasingly being conducted in developing countries. There are many reasons for this, including the fact that to test vaccines and drugs for some diseases like measles or polio, companies must go to a developing nation that has a large enough population infected with it. This trend of conducting clinical trials in developing nations makes clinical trial translation services all the more imperative, especially for informed consent forms, for three reasons: the number of official languages, literacy rates, and comprehension rates.
Clinical Trial Translation for All the Official Languages
Informed consent forms must be accessible to citizens across the country. In some developing countries, the number of official languages can be myriad. For instance, in India, they have 14 official languages. In Africa, which has 54 countries, around 2,000 languages are considered official by the African Union. The US technically has 0 official languages, though it’s easy to argue that it has at least 1 language that functions as an official language: English. Arguments can be made that Spanish and Chinese are close behind, though not as frequently recognized. Even if you count all these languages, that’s a total of 3 languages—compare that to India’s 14!
For All Levels of Literacy
Beyond the sheer number of languages, clinical trial translation services can help with literacy and reading comprehension rates. These are often lower in developing countries. When clinical trials come into these countries, they’re often recruiting subjects of low socioeconomic status. Understandably, poverty often goes hand-in-hand with a lower literacy rate. To return to the example of India, the literacy rate for adults is around 69% and falls to 41% when you focus on elderly citizens. Compare that to the 99% literacy rate of adults in the US. The literacy factor means that when a company goes to translate documents like informed consent forms, they must be written with language that is easy for all levels to read. Only professional business translation services can handle such a nuanced request, not amateurs.
Clinical Trial Translation for Better Reading Comprehension
The last reason clinical trial translation becomes imperative in developing countries is that even with participants who can read, true comprehension of informed consent forms can still be a problem. In one study, researchers were measuring reading comprehension for prospective participants who used informed consent forms. The researchers found that clinical trial translation must go beyond just conducting back-translation procedures. In the end, a major issue with consent form translations is not necessarily content accuracy, but content comprehension. The study recommended that IRBs develop templates of consent forms in various languages. They should be both professionally translated and pilot-tested for different levels of familiarity with research and consent forms. Otherwise, even the most literate, multilingual participant can still have a hard time truly understanding an informed consent form.
Dharma E. Cortés, Mari-Lynn Drainoni, Lori E. Henault & Michael K. Paasche-Orlow (2010) How to Achieve Informed Consent for Research from Spanish-Speaking Individuals with Low Literacy: A Qualitative Report, Journal of Health Communication
Coster W. J. (2013). Making the best match: selecting outcome measures for clinical trials and outcome studies. The American journal of occupational therapy : official publication of the American Occupational Therapy Association, 67(2), 162–170. doi:10.5014/ajot.2013.006015
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