When drafting informed consent forms, please make sure each page includes all the formatting elements required by IRB Policy 15.1. These include the protocol title or other specific identifier; the sponsor name; the institution where the research is being conducted; and page numbers and version date and number.
These elements help researchers ensure that the current, complete consent form is on file with the IRB and is being used in the consent process at the site. Consent forms that don’t include all required elements will be sent back with a contingency.