Checklists

Checklists have gotten a bad rap!! I, too, had a negative attitude toward checklists. It seems like they work against real ethical decision-making by IRBs. But, as I have been working with institutions going through accreditation (AAHRPP is big on checklists), my attitude has changed. I now see that, when used appropriately, checklists serve an important function in the IRB review process. Checklists don't ensure good IRB review, but they do help ensure that things don't "slip through the cracks". In order to do a good review, the IRB must carefully look at each of the criteria for approval in Section 111 of the regulations. Even the best IRB reviewer can miss something and review checklists help make sure that the reviewer considers all of the essential aspects of the criteria when doing the review.

You might say (and many do), that this is just a bureaucratic exercise to comply with regulations and does not do anything to better protect subjects. However, the criteria for approval in Section 111 implement the Belmont Principles (I'm going to do another post on that), so making sure that the review addresses all of the criteria ensures that the ethical principles are adequately addressed.

So, I've become a fan of good checklists, but they should be used as guidance not bureaucracy. It's not about checking off boxes, but about focusing the reviewer's attention on the important factors in ethical review.