July 17th, 2018
The Short Form consent process, as defined by Federal Regulations (see 45 CFR 46.117 and 21 CFR 50.27), requires the use of a witness who speaks English as well as the language of the participant. This witness is required to sign the Short Form Consent in the participant’s language, and the full English consent document. In this case, the witness’s purpose it to attest that the information was provided orally in a language that the participant could understand.
Conveniently, the person providing language interpretation commonly acts as a witness for the Short Form consent process. In order to clarify the exact role that the interpreter plays as a witness to the Short Form consent process, the University of Utah IRB has updated the Short Forms to include a statement with the interpreter signature lines. The Short Forms no longer refer to a “witness;” however, the witness requirements of the Federal Regulations are met with this change.
How to move forward with this change:
- Study teams must not change how they conduct the Short Form consent process; the process remains the same, though the signature lines have changed.
- Study teams will be required to update their approved Short Forms in ERICA as part of their next continuing review. Study teams may choose to submit an amendment to update their Short Forms prior to continuing review.
If you have any questions about this change, please contact the IRB.