An informed consent process note is distinct from the informed consent process form. While the form documents the information that is to be exchanged during the consent discussion (and is typically required by federal regulations), the process note documents that an actual consent process occurred. While the regulations don’t require separate process notes, UAMS IRB Policy 15.5 does.
The process note documents the entire initial consent discussion. The best written notes provide a complete record of things like what was discussed, who was present during the discussion, and whether the subject had any questions and, if so, what those questions were.
IRB Policy 15.5 requires consent process notes to include the following elements: the date the subject entered the study; the study’s name; the PI’s name; the name of the person(s) obtaining informed consent; and a statement that the subject or subject’s legally authorized representative was given a copy of the signed consent form.
Additional elements, although not strictly required, are encouraged to fully document the consent process. These elements would include a description of who participated in the process, such as the subject’s spouse or other family member; a summary of the questions the subject asked about the research or a statement that the subject had no questions; and any other details specific to that particular consent process, such as an explanation of any date discrepancies on the consent form signatures. In short, the reader should get a complete picture of the consent process from the information in this note.
Only the person obtaining consent needs to sign this note — the subject doesn’t need to see the consent process note. Therefore, the IRB is not required to approve consent process note templates. Ordinarily, a separate consent process note is required for each subject enrolled. However, the IRB may, at its discretion, approve different types of consent process notes for different types of consent situations, such as group consent processes, such as those for a focus group study that is not collecting individual participants’ names.