IRB Global Observational Study of Behavior in Children review

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
Iower 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 colIection and is more than
minimaI 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 and
ensure that assent forms are signed by all



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.


Sincerely,
E. Scrooge, MD

Chair, Institutional Review Board

=====================
To manage your subscription to SPSSX-L, send a message to
[hidden email] (not to SPSSX-L), with no body text except the
command. To leave the list, send the command
SIGNOFF SPSSX-L
For a list of commands to manage subscriptions, send the command
INFO REFCARD