Must consent be in a language the subject understands?

• A. Yes
• B. No
• C. Only for non-English speakers
• D. Only for minors

Answer: (A)

Consent must be in a language the subject understands. This ensures they truly grasp what participation involves, including potential risks, benefits, and alternatives, before agreeing. ICH-GCP requires that information be provided in a language and terms the participant or their legally authorized representative can understand, and that they have time to ask questions and consider the decision. If the subject doesn’t speak the site language, a translated consent form and an interpreter should be provided so they can understand and make an informed choice. This protects voluntary participation and respects the person's autonomy. Saying it’s not required would risk misunderstanding; making it only for non-English speakers would neglect those who understand English; making it only for minors would ignore adults who also need clear understanding.