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What else do I need to know about using a short form consent process?

• See FAQs Everything you need to know about consent for more information about the consent process for enrolling subjects who do not speak English.
  
  
• If enrollment of a non-English speaking subject is not anticipated, an IRB-approved short form consent in the language of the subject must be used. Translated short form consents are available on the OHSRP website on the Short Form Consents webpage
  
  
• If there is no IRB-approved short form consent document in the language of the subject, the NIH PI must submit to the IRB for approval (and before use), a certified translation of the short form consent in the language of the subject.
  
  
• An individual serving as the witness must be present at the site of the investigator obtaining consent and must observe the entire consent discussion.
  • The witness must be fluent in the language of the subject and in English.
  • In the vary rare instance that the translator is unable to act as the witness, and if the witness is not fluent in both the language of the subject and English, then the witness should verify the following with the interpreter:
    • The subject understands the information presented.
    • All questions have been satisfactorily addressed.
      and
    • The subject agrees to participate.
  • The witness, or investigator obtaining informed consent, should document the short form consent procedure in the consent note in CRIS/medical/research record.
    
    

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