Updated Requirements for “Short Form” Consent Method

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This bulletin pertains to existing and future IRB studies that use the Short Form consent method to enroll research participants who speak languages other than English.

Change in IRB Requirements:

The requirements for obtaining consent via the Short Form method have been updated. Here is a summary of the changes, effective immediately:

NewTranslated Short Form Consent Document
  • A new standalone form—the Short Form Consent Document— must be used when employing the Short Form consent method. This document is designed to meet regulatory guidance for supporting the verbal consent process when a fully translated consent form is not available. 
UpdatedExperimental Participant’s Bill of Rights (BOR)
  • The BOR document has previously served as the “short form” consent document for non-English-speakers. Moving forward, it only needs to be provided to participants (alongside the Short Form Consent Document) in biomedical studies.
  • The BOR has been updated to include fields for the IRB study number and study contact information, plus other minor formatting and language edits for clarity and consistency.

These documents are available on the IRB website in over 50 languages. Translated documents can be found here.

Detailed Guidance

For more information, please consult the following guidance:

My study involves the Short Form method. What should I do?

Do:
  • Effective immediately, use the new Short Form Document (and updated BOR, if it is a biomedical study) when consenting a non-English speaker.
Do not:
  • Submit a Modification to the IRB to reflect this change in the Short Form method.
  • Reconsent participants using the new/updated forms.

All updated documents (Bill of Rights, Translated Bill of Rights, Translated Short Form Consent Document, and Translation Certificates) are available online. Please note that links to previous versions are no longer active; use the updated versions on the website. 

Questions: Please consult the links above for guidance on the new Short Form process. If you have questions, submit an Ask Andy form.