The inclusion of non-English speaking participants must be previously approved by COMIRB. If you anticipate enrolling non-English speakers, address the recruitment, consent, and conduct of study visits with non-English speaking participants in your IRB
application.
A short form may be used up to three times in the same language. If a fourth participant is to be enrolled, the entire consent form must be translated. The translated consent form must be submitted to COMIRB for approval. Options for translation services can be found here.
When you wish to obtain short form consent from a non-English speaking participant, download the appropriate translations of the short form and the stand-alone HIPAA authorization (if necessary). Add study information to the top of the short form. Edit the HIPAA Authorization to match the approved English version for your study.
COMIRB has translated Short Forms on our website. If you do not find a short form in the language you need, contact COMIRB. We can usually provide a certified translation within three business days. If a translation is needed sooner than this, you will have to get the English short form translated into the appropriate language.
For more information, please review the COMIRB Short Form Consent Process Guidance.