The IRB has an updated protocol template available on its website. The new template has added some new information and moved some previous language around.
You’ll note that the new template has far more guidance than earlier iterations, and less suggested text. This change’s intent is to provide prompts to study teams to draft their own language specific to their research, rather than trying to make one-size-fits-all language fit their study. One thing we’ve noticed about one-size-fits-all suggested language is that it really doesn’t fit all.
Very important reminder — please please please start with a fresh template each time you start a new protocol. Starting with a clean slate is important for at least two reasons. First, you won’t accidentally leave in any language from your old nearsightedness study in your new heart disease study protocol. Second, each updated template addresses information the IRB needs to be able to approve your study. That means that if you don’t address an issue that is newly added to the template, you’ll get a contingency asking you for a correction. Clean templates mean faster approvals.