“If it’s not written down, it didn’t happen.”
That saying has been used in reference to documenting medical procedures (you can’t bill for it if you don’t document it) and also to conducting research (you can’t prove that you did it unless there’s a documentation trail showing you did it). It also applies to IRB discussions, as our site visitors from AAHRPP (Association for the Accreditation of Human Research Protection Programs) reminded us recently.
In response to AAHRPP findings, the IRB is beefing up its meeting-related recordkeeping. To that end, we have created new checklists to be completed during IRB meetings. The checklists address the regulatory criteria for approval for all research, and also for criteria specific to certain populations, when the research involves those populations (e.g., children). IRB Prereview
Again, you will not have to complete these checklists as you review studies. However, you may be asked to address some of the applicable criteria in your meeting discussion. A refresher on the criteria can be found in the IRB Policies linked below:
The special populations section (Section 17) has the policies for Children, Pregnant Women and Fetuses, and Prisoners
The criteria for approval of research are in IRB Policy 7.1.
Informed consent process and waivers policies can be found in Section 15.
We have also added a link where you can see the checklist for the criteria for approval of research. It’s at the upper right on your reviewer screen.