Do I need to submit the Short Form Consent documents?
No. The IRB no longer requires the investigator to upload the short form consent documents that are already available on the IRB's website. These documents are locked and are already certified translations. The investigator only needs to submit a Study Summary Document.
When may the short form consent process be used instead of a translated consent form?
The short form written consent is intended when few subjects with limited English proficiency (if any) are expected to enroll.
The short form consent process is ideal for situations where a subject whose preferred language is not English presents unexpectedly and a translated consent form is not available. If many subjects with limited English proficiency are expected to enroll, then a translated consent form should be used rather than the using a short form consent document.
Who needs to sign the short form consent document and the summary document?
These forms are signed by the individuals who understand the information on the individual form. The short form (in the subject’s preferred language) will be signed by the subject and the interpreter/witness. The study summary document (in English) will be signed by the study team member and the interpreter/witness. The Summary Document signatures attest that the information in the document was presented to the subject and that their questions were answered. The signatures on the short form document that the subject understood the information presented.
Is the witness certifying the medical accuracy of the information provided by the investigator or the Study Summary Document?
No, the witness is not certifying the accuracy of the medical information. The witness is attesting that the information has been presented in a language understandable to the subject, and that the subject understood the information.