Informed Consent知情同意
Informed consent is the documented process by which a patient or trial participant voluntarily confirms willingness to receive a treatment or take part in a study after being informed of its purpose, procedures, risks, and alternatives. Within translation and localization, the term usually refers to the informed consent form and related participant materials that ethics committees require in language patients can understand.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
In life science translation, informed consent appears primarily in clinical trial documents such as patient information sheets, consent forms, and recruitment brochures. It is handled during ethics committee submissions, site-level adaptation, and protocol amendments. Translators must preserve plain-language explanations of risks, procedures, and data protection while aligning terminology with the approved protocol and local regulatory expectations.
Translation checks
A frequent mistake is rendering consent forms in dense legal or academic language, which makes them hard for patients to understand and may violate plain-language requirements. Conversely, simplifying risk or procedure statements too aggressively can change the clinical meaning. Inconsistent terminology with the protocol or investigator brochure also creates delays and raises ethics committee queries.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.