Another example of an IRB out of control. "Mission creep" seems a mild
phrase to describe this example.
Marie
Ken Steele wrote:
Annette Taylor, Ph. D. wrote:
Hi Paul, et al:
Most universities like to just follow the federal guidelines so that
they don't have to reinvent the wheel and if there is a problem you
can always fall back on the lame excuse that you followed the fed
guidelines.
As such I don't think there is any real distinction between
"approval" or "IRB approval" but what does make a difference is the
level of IRB approval. Here it is in a nutshell, as I understand it:
You can have 3 levels of approval
exempt
expedited
full
Exempt does NOT mean that you do nothing; it means that you submit a
very brief statement of what you are doing, why the risk is minimal
(defined as no greater than that encountered in everyday life--and
the feds have a numbering system so you can just say under such and
such number guideline) so that benefits outweigh risks (briefly
note benefits, which can be indirect in terms of general advancement
of scientific knowledge--the need NOT be direct); how many
participants over what time frame will be interacted with and you
are done. Informed consent is usually not needed in these types of
studies because they are usually observations/assessments of people
in public places where the observees remain anonymous or surveys
with complete anonymity and no sensitive issues where by simply
returning the survey signifies consent. This is usually reviewed by
a single person. (And it sounds to me that most of the studies
mentioned by Jim M. for the science fair fit in here).
Hi Annette:
An "expedited" review at ASU is a full review. Here is a link to the
ASU expedited form instructions.
http://www.graduate.appstate.edu/orsp/forms_orsp/irb_exemptreview.pdf
I had my worst IRB encounter over an expedited review. It involved
the following situation. A student wanted to complete an undergraduate
thesis. He had been an RA on a childplay observational study. The
original study had received IRB approval at another university and he
had been listed on the original IRB form. His job was to code various
play behaviors, enter the data into the dataset and assist in
statistical summaries. He came to ASU with the original PI and
continued to work on the data set. By this time he had created an
anonymized data set. The original PI left ASU and had given him
official permission to continue work on the data set. At that point,
they had simple frequency counts of the behaviors. We wanted to do
something more sophisticated and decided to see if there were any
stable n-back transition probabilities (or play sequences).
So I had the student submit a request for an expedited IRB review in
which we included the original IRB from the other institution, pointed
out that he had been a member of the original lab group with official
access to the data and had been given permission to continue work with
that data set to further the originally approved goal. Additionally
the data set was now anonymized and I couldn't see any indentifying
information.
(The data set included information like "Child A runs toward Child B"
and the question was whether Child B responded to Child A by running
away, running towards Child A, or ignoring Child A.)
The official IRB stance was that we needed to go back to the parents
of these children and get consent. We pointed out that this would be
very difficult since the data was collected in Colorado from a daycare
center that was no longer in operation, that the student had
legitimate access to the information, and that the analysis was part
of the originally approved project. No go. This was work being done
at ASU and now the project needed ASU approval.
It took almost 3 months to work out a compromise. The final solution
was to reanonymize the data a second time. I was very proud of that
student for persisting under a set of conditions that would have
defeated many faculty members.
Ken
---------------------------------------------------------------
Kenneth M. Steele, Ph.D. [EMAIL PROTECTED]
Professor
Department of Psychology http://www.psych.appstate.edu
Appalachian State University
Boone, NC 28608
USA
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Marie Helweg-Larsen, Ph.D.
Associate Professor of Psychology
Dickinson College, P.O. Box 1773
Carlisle, PA 17013
Office: (717) 245-1562, Fax: (717) 245-1971
Webpage: www.dickinson.edu/~helwegm
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