Translations

If a site plans to consent non-English speaking subjects, the investigator must obtain translations of all Schulman approved informed consent documents and questionnaires, diaries, recruitment materials, and subject information sheets, etc., into the language that the subject can read and understand. Non-English speaking subjects must receive the same information that English-speaking subjects receive during the study.

The translation must be completed and certified by a professional translation service and submitted to Schulman for approval. Please read the  Guidance For Obtaining Translated Documents.

The investigator should have an employee and/or staff member present during the consenting process who is fluent in the subject's language and capable of explaining the study. The site should also have an employee and/or staff member available throughout the study who is fluent in the subject's language to answer the subject's questions or translate the study doctor's answers to questions.