Informed consent translation

Medical text and documents require next-level scrutiny due to the fact that these might play their role in death and life matters. Patient-informed consent forms are particularly important not only because these are scanned through strict regulatory bodies such as the food and drug administration (FDA) and institutional review board (IRB) but also because of the fact that language should be clear enough to have proper consent by a non-English speaking subject.

Informed consent translation plays a vital role in convincing a non-English speaker and people from the targeted region. The volunteers will need the whole content in their native language to understand the process and the dos and don’ts. The medical companies can only get legally qualified consent from the participants when they provide the content in their language.

This legal document might include

  • Conducting clinical trials overseas.
  • Targeting non-English subject groups from the predominant clinical trials.
  • Targeting a particular class of people for clinical trials who do not speak the English language.

Translation of the consent forms could require a detailed process with great vigilance and subject matter expertise. 

Here are six important tips that can help with the translation of informed consent forms.

Conforming recommended standards and guidelines

Certified translation of informed consent forms is only achievable when the team conforms to the defined rules and standards set for the purpose. A few are really imperative to be mindful of. One of these is not using exculpatory language and keeping the written content simple and plain to make sure that the language can easily be understood by others. These requirements go for English and non-English speakers both. If there is any scientific or technical term it should be clearly mentioned and explained. Although it is better to replace it with some simple terminology that readers and users can understand better. In case of technical content in the document, you should be vocal with your translation vendor to hire someone who has the industry knowledge to avoid mistakes and mistranslations.

Getting FDA and IRB approval for the English text before translation

The final approval of a clinical trial belongs to the FDA and IRB. Therefore, any changes required should be there in the final trial documents so that the process moves forward smoothly. With the translation of consent forms also comes the translation of IFUs of different products. People often fail to interpret medicine, and its dose the right way. Therefore, a leaflet or precise text about usage should be mentioned above there in multiple languages.

Conducting a translation of the informed consent could be a costly process and time taking too. Hence, it is important to carry out it in the best way possible. So, it is mandatory to get it approved by all the required bodies and necessary institutions.

Preparing a high-quality source document

The next tip puts great emphasis on quality.  A good translation is nowhere to exist without a good quality source document. Therefore, you need to be sure about the quality of the original document. This is particularly vital to ensure when considering the delicate and technical nature of the informed consent form. Even a professional translator can rarely predict the crux of the content in the main language and document. It should be a quality document that contains everything that is needed by the translators to deliver well. The companies should ensure they cross-check their source documents multiple times to submit them for source material.

Using a professional translator with proven experience

Medical text and translation drug study labels as well as product labels and consent forms is a complex task that requires translators with relevant expertise and sound experience to ace the translation task. Translators with industry specialization can help prevent the misunderstanding of documents. Translators who have experience in life sciences and medical content can help with the quality translation of all types of medical documents. Experienced translators also understand the terminology and identify appropriate language that can maintain the integrity of the source documents. Thus, only experienced translators can deliver the content more accurately.

Implementing localization strategies

Cultural factors can affect the quality and accuracy of consent forms greatly. It can make the target audience come up with complaints and issues. Moreover, even people inside the states register their complaints with the HIPAA Health insurance portability and accountability Act). People from diverse cultures and speaking different languages also come forward with their reservations which makes authorities seek help for HIPAA-compliant translation services. They get the complaints translated which are in languages other than English. Hence, a literal language commonly yields a text that makes less sense because it lacks cultural factors in reference to the target region. When you are overseas, it is particularly important to take care of certain factors which include formatting and a full understanding of the subject.

Identifying patients’ native language

For the translation of consent forms and certified medical device IFU Translation, it is vital to know the native language of the patient. A lot of countries have multiple official languages and many countries have distinct dialects of even a single language. Therefore, you can only translate the instruction manual or consent forms when you know the right language of the targeted consumer.


Translation of particular medical documents often gets tough and complicated. Therefore, following certain tips and taking some relevant aspects into consideration can help to deliver quality content. The medical companies who require to fill the consent forms overseas should make sure they know the right strategy to translate the content.

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