(Revised 7/26/07)

The Office of the IRB provides a generic short informed consent form to be used for the occasional circumstance in which a potential subject does not read or understand English.

The form can be used under the following conditions, according to the Code of Federal Regulations for the Protection of Human Subjects (45 CFR46.117(b)(2) (2): "A short form written consent document stating that the elements of informed consent required by § 46.116 have been presented orally to the subject or the subjects' legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form."

For further guidance see Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English.

Note: If an investigator anticipates the participation of non-English speaking populations in a study, he/she must obtain certified translated versions of the consent form in all relevant languages.

Short informed consent documents are available in the following languages: