You know how we’re always harping on about always starting with fresh protocol and consent templates, and don’t try to adapt old documents to new studies, because we’re constantly updating template language to reflect new regulations, guidances, or best practices?
Well, the updated protocol template we just now posted on the IRB’s website is an illustration of why we want everyone to start fresh. This new template includes language about the requirement for consent processes to be documented separately in the research record. (Yes, this is in addition to obtaining a signed consent form, when a signed form is required. See IRB Policy 15.5 for details.) While this requirement for separate documentation isn’t new, it IS often overlooked. We hope including it in the protocol template will get study teams thinking about this separate documentation requirement.
As an added bonus — we finally fixed that weird formatting issue that required you to create two separate footers in a protocol, one for the first page, and one for all the rest. Now a single footer covers it.