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.
Updated
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.
Chinese document application
Informed Consent in context · participant-information set
- English source
- Explain the study before obtaining informed consent.
- Chinese rendering to review
- 在取得知情同意之前说明研究情况。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Distinguish the consent process from the signed form. Chinese participant wording may need a different register from a professional protocol while retaining the same study facts. Preserve conditions and voluntariness wording from the approved source, and return unclear passages for sponsor review.
Check the returned Chinese file
Read the Chinese participant sentence beside the corresponding professional definition. Confirm that plain-language editing has preserved the study fact and process timing, and record any proposed change requiring sponsor confirmation.
Prepare the connected files
Provide the current participant information, consent form and relevant protocol definitions. Agree the intended audience and review process without treating translation as ethics approval.
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.
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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.