The Ethics Dept Going Merry Christmas A Research Ethics Christmas
Dr. K. Kringle,
Adjunct Professor of Child Psychology
Far Northern University
Dear Dr. Kringle:
At the regularly scheduled December 19 meeting, the REB 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. Kindly modify your study to address the following 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 a study.
2. You propose to "know 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? Are you proposing covert surveillance of your subjects? Is there any risk that children who do not believe in Santa Claus will also be video-recorded?
3. Your primary outcome measure is to "know 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? What if they have been really, really, good except for one time when they hit their little brother?
4. 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 children with obesity, dental caries, 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 better.
5. 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? What plans are there for long-term disposition of the scroll.
6. You mention the participation of "eight tiny reindeer" in your protocol. Please provide the Board with file number of your approved animal use protocol.
7. Please provide evidence of Part 1 animal user training and Part 2 Reindeer training for yourself and for anyone else involved in the care and handling of the reindeer. As well, attach your SOPS for animal husbandry and monitoring.
Please submit these changes and additional documentation by modified your online submission and responding to the reviewer notes. If you require assistance with REMO, please contact the Research Ethics Office or the committee coordinator.
Please note that the office will be closed from December 25 to January 1 inclusive.
Once your changes are approved, you will be able to conduct your study sometime in January.
E Scrooge, PhD, MD — Chair, Research Ethics Board
cc A Grinch – Chair, Animal Care and Use Committee