Office of Research Integrity
Institutional Review Board for Human Research (IRB) Front Page
ANNOUNCEMENT REGARDING Non-English Speaking Subjects - What is a Short Form Consent?
To meet the federal requirements, the informed consent document should be in a language understandable to the subject (or authorized representative), and a copy of the consent document must be given to each subject. When the study subject population includes non-English speaking people the IRB requires a translated consent document to be prepared and submitted to the IRB with an assurance that the translation is accurate.
If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. If investigators enroll subjects without an IRB approved written translation, a “short form” written consent document in a language the subject understands should be used to document that the required elements of informed consent were presented orally.
What is a short form? The short form is a modified consent form written in a language understandable to the subject (or legally authorized representative) that outlines the basic requirements for informed consent.
Where is the short form located?
The short form consent is available on the IRB website http://academicdepartments.musc.edu/research/ori/irb/forms.html
How do I use the short form consent? The short form consent process requires the assistance of a translator and the presence of a witness. A guidance document provides detailed information on the requirements for the person obtaining consent, the translator and the witness.
What happens after the short form is used?
Within 30 days, the PI must submit an amendment to the IRB with a fully translated informed consent to be used to re-consent the subject and to consent future non-English speaking subjects.
Does the IRB have a detailed policy about enrolling Non-English Speaking Subjects?
Yes. HRPP 7.5 provides a thorough outline of the necessary requirements and is located on the IRB website at http://academicdepartments.musc.edu/research/ori/irb/HRPP/HRPP%20Guide%20Section%207.5
What about HIPAA?
There is now a fully translated Spanish HIPAA Authorization available for all investigators to use. It is located on the IRB website http://academicdepartments.musc.edu/research/ori/irb/forms.html