As a general rule, case reports represent
anecdotal observations NOT research, therefore they would NOT require IRB approval.
The federal regulations define research as an activity designed to contribute
to generalizable knowledge and a report of observations on 1 or 2 patients probably
does not contribute to generalizable knowledge. BUT when a series of patient
observations is compiled in such a way as to allow possible "extrapolation"
of the results from the reported cases to a much larger population, it probably
does represent research. A good rule of thumb may be that anytime statistics
are utilized to analyze the observations from patients in a report, you probably
have crossed the line into research. The use of statistics (e.g. standard deviations,
etc.), by definition, is designed to allow the reader to generalize from your
observations on a small number of patients to a larger population.
A "safer" rule of thumb
would be that anytime the report will deal with more than a single patient you
should seriously consider that you may be "stepping across the line"
into research and you should contact the IRB office for advice. One caveat about
this "safer" rule of thumb is that an activity involving only a single
patient may represent research. It would be research if there is clear prior
intent, i.e., before treating the patient, to use systematically collected data,
that ordinarily would not be collected in the course of medical practice, specifically
for use in the case report.
Regardless of whether or not IRB
review/approval is required, care must be taken to protect the confidentiality
of private information associated with the patient involved in the case report.
In all cases, if you are unsure whether
what you want to do may be construed as research, please contact the IRB office
for guidance.
Page Updated: 9/24/1999
research@meduohio.edu