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 Document (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.
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. For more information, please see 
Guidance For Enrolling Non-English Speaking Subjects and Obtaining Translated Study Documents.
For sites in Québec, Schulman will automatically provide a Canadian French translation of the IC in addition to the English IC. Canadian French translations are subject to standard translation fees.
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 order to enroll non-English speaking subjects, there must be someone at the site who is capable of answering questions about the research in the language of the non-English speaking subjects. During the consenting process the investigator must have present an employee, study staff member and/or impartial translator who is fluent in the subject's language and capable of explaining the study. The investigator must also have an employee, study staff member and/or impartial translator available throughout the study who is fluent in the subject's language to answer the subject's questions or translate the study staff's answers to questions. A copy of the translated IC must be given to each non-English speaking subject.
Please Note: A family member or friend of the subject may not serve as an interpreter or translator.
For more information about enrolling non-English speaking subjects, please see Safeguards for Vulnerable Subjects.