Short Form Use
A “short form” consent process is generally used when there is a language barrier, and a translated consent document is not immediately available. If a non-English speaking subject is unexpectedly encountered, investigators may not have a written translation of the consent document and must rely on oral translation through the short form process.
The short form process is ONLY allowed in the following situations:
- There is a potential for direct benefit to participants that is not available outside of the research; or
- The IRB approved a revised English version of the consent form, directed that currently enrolled participants sign the IRB-approved revised version; and the translated version of the document is not yet available (clinical trial)
An appropriate short form template must be uploaded in the consent section and the following items MUST be included in the protocol (initial review or modification):
- Justification for using the Short Form
- Description of the Short Form Consent Process (how will it be conducted and documented)
[For details on documenting consent with the short form, see Section 7.7 of the Investigator’s Manual and HRP 317 - WORKSHEET: Short Form of Consent Documentation]
- A clear plan for obtaining consent with an IRB-approved translated consent document as soon as it is available.
Things to Consider
- Do you truly not have enough time to obtain a completely translated informed consent form?
- What are the ethical/legal ramifications of enrolling subjects when a language barrier exists?
- Are you confident that the short form process can be performed effectively, and you will be able to ensure that the subjects understand all aspects of the study?
- Do you have the capacity (4-5 individuals required) to carry out the process?
