Translational Certificate

Consenting Non-English-Speaking Research Participants

The BRI IRB requires that specific procedures be followed for consenting non-English-speaking research participants. The following documents must be submitted to the BRI IRB Office for approval, prior to consenting such participants:

• A written statement that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the participant or legally authorized representative. Note: Use the "short form" template form and instructions available here.
• A written summary of what is to be said to the subject (to be signed by the witness and the person obtaining consent). Note: The IRB-approved English language consent document(s) may serve as this written summary, and
• A completed BRI Translation Certificate

If you know you will be accruing non-English-speaking participants of a particular language at the time you submit a new IRB application, these materials should be included in your IRB application packet.

If you have an existing study and the opportunity arises to consent a non-English speaking participant, submit a "Study Modification Form" along with the above three documents for IRB approval.