Use of Approved, Standard Short Forms
In October 2022, the University of Utah IRB approved a policy change which allowed the IRB to grant general approval of a standard short form document. This change was intended to streamline the procedure for approval of short form documents and relieve administrative burden.
When is a short form used?
The short form consent process is a method of documenting informed consent. A short form consent process may be used for non-English speaking participants when a fully translated version of the full consent document is not available in the participant's language. The short form document outlines the required elements of informed consent.
What does this change mean for investigators?
The IRB will continue to review the proposed use of the short form consent process (as outlined by researchers in the ERICA application). However, investigators do not need to attach the standard short form document to the ERICA application. Once the IRB approves a short form consent process for a study, the standard University of Utah short form, available on the IRB website may be used. The standard short form has been translated into many other languages which are also available on the same webpage. Translated versions of the standard short form document may also be used without attaching them to the application as long as its use has been approved by the IRB.
If an investigator wishes to use an alternative to the standard short form or translate their own version, it must be attached in ERICA to be reviewed and approved by the IRB prior to use.
When is this change effective?
This change is effective now. Any current application requesting a short form consent process will not be required to attach short forms. Approval letters will now include language which indicates approval of the short form consent process. Short forms may be removed from applications at continuing review or with amendments. Investigators are not required to submit an amendment to remove short form documents.