Healthcare Technology Featured Article

September 28, 2021

Things You Must Know About Translating Informed Consent Forms




A lot has been written about ensuring that the language of informed consent forms is at a level that is easily understandable, and for good reason. The Food and Drug Administration requires all consent forms to be provided in a language that can be easily read and understood by a patient or their representative. Additionally, informed consent should always be in writing. However, there are many people that do not speak or write English and the best way to include them in a study is by providing translations of the consent forms. Here are a few things you need to know about informed consent form translation.  

  1. The clinical investigator, Institutional Review Board and research sponsor will be responsible   

    Three parties are responsible for informed consent including the clinical investigator, the research sponsor and the Institutional Review Board. The investigator must get consent from the subject of the study and will be responsible for it even if somebody else has interacted with or obtained the consent from the individual. Even if the investigator is assisted by the study staff, the job of obtaining consent remains on the clinical investigator only.  

    2.  Scenarios to translate the forms 

    If the consent interview is in English, then the form should also be in English. In case the interview is carried out in a different language, then the informed consent form will have to be translated and then shared with the subject. The form should be translated in four scenarios. When the individual understands and reads English at a sixth-grade level or higher, then there is no need for a translated version, but when the individual is unable to read English but can understand spoken English, it will be necessary to have someone read the form for them in the presence of a witness and then verify their ability to understand by getting signatures from them. When the individual is unable to read English, but he has fluency in a different language, then translation of the form that includes the information will be essential. Lastly, when an individual is unable to understand or read English, or any other language, but can understand it orally, a translated version will be read to them and a witness will put his signature on the form in the presence of the subject as well as the individual seeking consent.  

    3.  The translation should be performed to the patient’s understanding level 

    The informed consent forms should be in a language that can be easily understood by the participant. Hence, it should be in simple, plain language to begin with, and when translated, it should be in simple, plain language in the target language. The best choice for having someone translate the documents will often be an individual who is not only a qualified linguist but has a Master's degree in Public Health and has interactions with patients regularly. 

    4.  The translation will require an accuracy certificate 

    The Institutional Review Board will review before approving the translated versions of the form in some cases. In the review process, the translations will have to be submitted with a translation accuracy certificate. This certificate will verify that the linguists were certified and a certified process was followed while performing the translation activity.  

    5.  Sometimes a back translation will be necessary 

    In some cases, back translation is done while translating the forms to ensure that the translation is appropriate. For example, when the clinical trial involves complications or carries risk, the form may need to undergo back translation as a requirement of the Institutional Review Board. The process involves taking the translated version of the form and having a different translator translate it to the original language. Both versions will be assessed for consistency and quality before being harmonized, and then approved by the board.  

    6.   Interpreting services can also help 

    It helps to have somebody from the study who can answer all the questions participants may have. When the participant understands a different language, then there should be an interpreter present there. The interpreter should speak their language fluently. The individual who interacts with the participant and who is getting the consent should communicate about the study and answer all their questions. Participants should know whom to get in touch with when issues come up and the contacts should be people who communicate in the language that is easily understood by them.  

    Informed consent forms are necessary for all study and medical procedures. In the case of individuals who have limited English understanding, it is important to make provisions for translation and to provide interpretation services to the individuals. Translation of these forms is a complex process and should only be performed by expert individuals. The purpose of the translation is to ensure that all participants understand the context of the study and are aware of what they are getting into. In some cases, interpreting services can be ideal and will fulfill the purpose of translation in a simple and straightforward manner.   








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