I’ve been doing human research for better than a decade now (and, yes, I did just appeal to authority). Every study that I have ever done has at some point touched an Institutional Review Board and every study has involved some consideration of how to obtain informed consent.
IRBs can do a couple of things when they consider a study. They can approve or deny approval for a study’s conduct. They can exempt the study from review, meaning that the investigators may press on without IRB involvement. They can approve an informed consent process and document, or they can waive the requirement for informed consent.
Every paper that I have subsequently written has been published in a journal that requires two statements be made – 1) What is the study’s status vis-à-vis the IRB and 2) how was informed consent obtained?
I’ve been very fortunate because my studies have been straight forward. I’ve been able to state simply “This study was approved by the Institutional Review Board of the MRU School of Tomfoolery. All participants provided written informed consent.” Done. Moving on…
But what if your study was deemed exempt or you got a waiver to either not need to get consent or get verbal consent or some other such fuckery?
Well, then you say that. You don’t say your protocol was approved if it was exempted from review. That’s not the same. And you don’t say anything about informed consent except the actual way you obtained it.
A mi, no me jodas on this one, scientists. No me jodas.
(Motivation for this rant can be found here. Carajo.)