If a site plans to consent non-English speaking subjects, the following items must be translated into a language that the subject can read and understand:
Schulman-approved site-specific Informed Consent (IC)
Applicable attachments to the IC (e.g., California Bill of Rights, additional consents)
Any study-related materials (e.g., subject diaries, questionnaires, subject information sheets)
Any recruitment materials used for the recruitment of non-English speaking subjects.
Any information required by the Board for distribution to subjects, as directed.
The translated documents must be submitted to Schulman for review prior to use. The formatting should “mirror” the English document’s formatting. The translation must be completed and certified by a professional translation service.
During a study, non-English speaking subjects must receive in their language the same information that English-speaking subjects receive. If, during a study, a Schulman-approved study document is revised, the translated version likewise will require revision and must be submitted to Schulman for review prior to use.
In addition to the translated documents, someone must be available who is capable of answering questions about the research in the language(s) of the non-English speaking subject(s). The Board requires that an employee, study staff member, and/or impartial translator who is fluent in the subject’s language and capable of explaining the study be present during the consenting process and be available throughout the study to answer the subject’s questions and translate the investigator’s answers.
For more information about enrolling non-English speaking subjects, please see Safeguards for Vulnerable Subjects.