We’ve made a small-but-significant update to the IRB’s protocol template. A sharp-eyed reader noticed an important word (“waiver”) was missing in the language requesting a HIPAA authorization waiver. It’s not missing anymore.
And we’ll take this opportunity to remind everyone to always start with a fresh protocol template when creating a new study. Trying to update a previously approved protocol for a new study is strongly discouraged. First, you’ll probably accidentally leave some text about the old study in there. Really — we see this a lot. Secondly, we often update our protocol template, and if you use an old study, you won’t get any new protocol language. Recent changes have included adding language about HIPAA authorization waiver requests, multisite research, and data and specimen handling, all of which are becoming more relevant for the types of research we see now.
And to address comments that our consent and protocol templates are becoming too long (yes, we’ve gotten some) — the material that does not apply to your study can be deleted. You don’t need to leave it in there “because it’s template language so I thought it was required.” It’s not required if it’s not applicable. Including everything in the blank template makes it easier for study teams to figure out what information the IRB needs to make the determination it’s required to make. That, in turn, leads to fewer contingencies and quicker approvals.