5 Tips For Patient Informed Consent Form Translation

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• Whether your organization needs a full IRB-approved translation of an informed consent form or simply a translated short form, here are a few important steps to take to prepare for this type of translation.
• 1. Conform to the recommended standards and guidelines for ICF documents
• In the event that an IRB-approved ICF document is not available for a non-English speaking subject, an IRB-approved translated short form must be provided to the subject in their native language.
• When dealing with informed consent for non-English speaking patients with limited literacy, or when conducting a consent interview using a short form, a trained interpreter must be present.
• Interpreters will ensure proper communication of the form’s content and trial information, in addition to obtaining the subject’s consent.
• 2. Get FDA/IRB approval of All English texts before translation
• To avoid costly re-translations, it is best to wait until after your English language version has been approved by the necessary institutions before investing in translation services.
• The job of a professional translator is to render the source text into the target language. As such they can not be held responsible or liable should changes be made to the English text after the translation was solicited or completed.
• If you do need to make changes to the source document during the informed consent form translation process, this needs to be clearly communicated to the translation agency so they can make the necessary changes.
• 3. Prepare a high-quality source document
• Check the readability and quality of the source documents prior to ICF translation. A good translation is directly dependent on the quality of the source document.
• A professional translator can not always predict what certain language means, or fill in the blanks if everything is missing. Therefore, it is a good idea to review your ICF documents before submitting them as source material for translation.
• 4. Use a professional translator with a background in life sciences
• Translators with backgrounds in the life sciences and other similar fields possess important background knowledge of necessary processes for clinical trials and ICF requirements.
• Experienced translators also take great pains to use well-established terminology and identify appropriate language equivalents in order to maintain the integrity of the source document.
• As such, using a translator with a background in the life sciences or clinical research will allow them to do this more accurately for your informed consent form translation.
• 5. Identify the patients’ native language(s)
• In some cases, the native language of the target patient population may be different from the country’s official language(s). You must be sure of the proper language of your subjects, allowing them the greatest ability to understand and consent to the trial.
• If this means providing the documents in a rare dialect, or in multiple languages depending on the demographics of the area you are targeting, this must be determined prior to submitting informed consent documents for translation.

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