Informed Review

I know it's January, but that somehow makes this IRB appraisal of Santa's activities more timely. Excerpts below (via Grahamazon):

1. You propose to study "children of all ages". Please provide an exact lower and upper age limit, as well as the precise number of subjects. Provide a statistically valid power calculation to justify this large of a study.

7. The database of good and bad children will be kept "on a scroll at the North Pole." Please describe the security provisions you have in place to protect the research data. Is the scroll kept in a locked cabinet in a locked room? Who has access to the scroll? Are there backup copies of the scroll and how often are they compared to the original?

10. As this study involves prospective data collection and is more than minimal risk without prospect of direct benefit to the subjects, informed consent signed by both parents will be required. Please have the consent form translated into every language spoken by children.

In googling for more IRB rants, I found this thoughtful blog post that points to a number of papers considering the ethics of IRB regulations. A 2003 report on IRB Mission Creep seems like an evenhanded approach to addressing some faults in the system.