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COVID-19 Informed Consent

Infectious doctor show COVID 19 vaccine for prevention,immunization and treatment for new corona virus infection(COVID-19,novel coronavirus disease 2019 or nCoV 2019 from Wuhan). Medical technology.

According to the Center for Immigration Studies, over 63 million people in the United States speak a language other than English at home. Of these non-English speakers, Spanish, Chinese, Tagalog, Vietnam, Arabic, French, and Korean have over one million speakers each. With a large number of non-English speakers, how can doctors and researchers ensure that patients and research participants are given the same right to informed consent as their English-speaking counterparts?
With Coronavirus clinical trials currently recruiting participants, it is critical that researchers provide comprehensive informed consent for their non-English speakers. Because of social distancing and quarantine regulations, some studies may permit participants to consent via phone, video chat, or email. This presents its own challenges, as the ability to ensure each non-English speaker understands the literature diminishes due to a lack of in-person interaction. It is an accepted practice to allow a short form document and/or a verbal representation of informed consent to be given to a non-English speaker during clinical trials; yet, this presents the same problems.
A 2018 study sought to identify potential issues with translating informed consent materials from English to Spanish, encountered three major problems: the introduction of complex language, the reduction of clarity of information, and changes made during the translation that affect the meaning of the information presented.
Four companies were hired to translate the informed consent materials from English to Spanish, while the Spanish-speaking research team did their own translation. Back translations were completed to compare the translated Spanish to the original English. The results show that the translation firms used longer, more complex sentence structure and technical terminology, sometimes incorrectly translating important terms in the process. Another discrepancy was the omission of the word “please” from the documents, altering the tone of the documents. One company eliminated the word “health” from health insurance, changing the meaning of the phrase, which could have legal ramifications for those giving the informed consent. In all instances, translations completed by the research team were more accurate.
To ensure accuracy of information and correct tone, the researchers suggest employing translators who not only have a firm grasp of the target language, but also a contextual and socio-cultural understanding, as well. It would be an added benefit for the translators to work closely with the researchers to ensure optimal results.
With an expected increase to the already high number of non-English speakers in the United States, it is more important than ever to ensure patients and research participants have access to informed consent materials that are easy to understand. With clinical trials for potential COVID-19 vaccines in the works, it is vital for these materials be available in as many languages as possible, as soon as possible. As always, World Translation Center is available to assist with your translation needs, with many translators who specialize in medical and scientific translation.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218315/

 

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