Informed Consent Forms (ICFs), setting out information about a clinical trial and its conduct, are essential in gaining the patient’s written consent to participate in the trial by signing the document. The guidelines used to create ICFs are based on medical ethics and research ethics, requiring that "the information that is given to the subject or the representative shall be in language understandable to the subject or the representative." It is mandatory to help the non-English speaking population understand ICFs' content in the native language. Accurate, legible, understandable, and honest translations of ICFs for the target language population are indispensable to carry out the medical procedures or clinical trials.
Detailed Information Included in ICFs
Patients' or participants' physical condition
Treatment or research requirements
Essential design elements of the trial
Risks and benefits of procedures
Agreement between the patient/participant and the clinical team
- Conform to the recommended standards and guidelines for ICF documents.
- Prepare high-quality source documents, or get FDA/IRB approval of all English texts.
- Use professional translators with a solid life science background.
- Identify the patients'/participants’ native language(s) prior to submitting informed consent documents for translation.
- Implement localization strategies, such as preparing the translated Informed Consent Form in a right to left reading format, changing numerical and currency formats, culturally sensitive explanations for parts of the trial, etc.
- Back translation for Quality Control of Informed Consent Forms
As a language service provider with an extensive understanding of clinical trials, MedTrans provides ICFs translation service to ensure that patients/participants understand what is involved in the planned clinical trial. Even a small mistake in translation can change the meaning of the entire content. Documents with legal requirements need to undergo extra levels of scrutiny when being translated. MedTrans follows stringent quality processes in translating an Informed Consent Form to meet the requisite standards and requirements of the Food and Drug Administration (FDA) and the Institutional Review Boards (IRB). Our team has years of experience working with informed consent documents for non-English speaking or limited English proficiency (LEP) individuals. Our medical documents translation services are of great accuracy and high-quality. We would be happy to guide you through the process.
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If you are a clinical investigator or a principal researcher, you may also be interested in Linguistic Validation, Clinical Trial Translations, Regulatory Translation, Pharmaceutical Translation and Patent Translation.
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