Tuesday, December 25, 2007

Santa and the IRB

Dr. K Kringle
Adjunct Professor of Child Psychology
Far Northern University

Dear Dr. Kringle (Ph.D, M.D., D.O.? Please verify your credentials):

At the regularly scheduled December 24 meeting, the IRB reviewed your protocol, "A Global Observational Study of Behavior in Children" While we believe it has many good features, it could not be approved as submitted. If you choose to revise your study, please address the following IRB concerns:

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.

2. Your only inclusion criterion is "belief in Santa Clause." Please provide a copy of the screening questionnaire that determines such a belief. Provide a Waiver of Authorization under MPAA in order to record these beliefs prior to enrollment in your study. The Board recommends that you obtain a Certificate of Confidentiality as beliefs are sensitive and personal information.

3. You propose to "how when they are sleeping and know when they are awake". How will this be done? Will children undergo video monitoring in their beds? Will they have sleep EEGs? You list 100 elves as research assistants. Are any of them sleep physiologists? Please provide credentials of elves.

4. Your primary outcome measure is to "how when they've been bad or good." What standard is being used to determine "goodness'? Do children have to be good all year or just most of the time? Please specify required duration and provide the instrumentation, with appropriate consent forms, that will be used for operationally defining "goodness".

5. You propose to conduct your research by entering the subjects' homes through the chimney. Have you considered the liability potential, i.e., damage to the roof, carpeting, etc., that this will cause? Moreover, children are likely to be startled by your appearance late at night. Please revise your protocol to conduct your home visits between 9 am and 5 pm Monday through Friday with at least one parent being present and all risks and benefits carefully described.

6. You state that compensation for participation will be "sugarplums, candy, and toys" for the good little girls and boys. This may not be appropriate for the chiIdren with obesity, dental cavities, and hyperactivity. Also, your proposal to leave a lump of coal in the stockings of the bad children will be unfairly stigmatizing to them individually and as a group. In general, the Board suggests a small token of appreciation for all participants. Perhaps a $5 Toys-R-Us gift card would be more appropriate in order to avoid potential coercion.

7. The database of good and bad children will be kept "on a scroll at the North Pole." Please describe the location of the scroll and the security provisions you have in place to protect the 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?

8. You mention the participation of "eight tiny reindeer" in your protocol. Please provide the Board with documentation of Institutional Animal Care and Use Committee approval.

9. Please provide the Human Subjects Protection training dates for Mrs. Claus and the elves.

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.

Please submit 25 copies of your revised protocol to the IRB. The IRB will be on Holiday Season schedule for the next two weeks. If approved, you will be able to conduct your study sometime in the spring, if all items are appropriately addressed.

E. Scrooge, MD
Chair, Institutional Review Board

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