The inclusion of non-English speaking participants must be previously approved by COMIRB. If you anticipate enrolling non-English speakers, address recruitment, consent, and conduct of study visits with non-English speaking participants in your protocol and IRB
application. You will need to decide whether you will translate the consent form or use a short form consent. If you use a short form, submit an English stand alone HIPAA authorization to COMIRB for prior approval.
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.
Translated Short Forms and HIPAA authorizations are listed below. 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.