An informed consent short form document must be written in a language understandable to the subject and given to subject with the study summary document (e.g. English consent document).There has to be a witness to the consent process. The subject will sign the short form and the witness will sign the short form and a copy of the study summary English version. The study team member who is conducting the consent interview should also sign the English study summary (e.g. English consent document).
Use of the short form should be reported to the IRB at the time of continuing review. The IRB will determine trends and whether a translated consent form is required.
If there is not a short form or standard consent document available in a language understandable to the subject, please contact the Human Subjects office.
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