The use of the short form is allowed under certain circumstances in which a potential research subject may be blind or illiterate.
Use of a Short Form Written Consent Document for English Speaking Subjects
The Institutional Review Board allows oral presentation of informed consent information in conjunction with a short form written consent documents (stating that the elements of informed consent required by Sec. 46.116 have been presented orally) and a written summary of what is presented orally to the subject. 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. Only the short form itself is to be signed/dated by the subject. However, the witness shall sign/date both the short form and a copy of the summary, and the person actually obtaining consent shall sign/date a copy of the summary. A copy of the summary shall be given to the subject, in addition to a copy of the short form.
Use of a Short Form Written Consent Document for Non-English Speaking Subjects
When this procedure is used with subjects who do not speak English, the oral presentation and the short form written documents should be in a language understandable to the subject. The IRB-approved English language informed consent document may serve as the summary. It is strongly recommended that the full English consent be translated into the participant’s language. The translator/interpreter should be fluent in both English and the language of the subject. There must be a witness during the entire consenting procedures. Adequate time should be afforded to the subject, to make an informed decision regarding participation in the research.
At the time of consent, the short form document must be signed and dated by the subject and the witness. The summary must be signed/dated by the person obtaining consent (as authorized under protocol) and the witness. The translator/interpreter may serve as the witness. A copy of the summary shall be given to the subject, in addition to a copy of the short form.
If a member of the study staff speaks the subject’s language, the staff member can act as the translator/interpreter and person obtaining consent, but should not also act as a witness.
Expedited review of all foreign language versions are acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.
It is the responsibility of the IRB to determine which of the procedures at 46.117(b) is appropriate for documenting informed consent in protocols that it reviews.