Dr. Haldorsen had been collecting general health information from all his kinesiology research subjects for years. The IRB had agreed with him that collecting information about potentially disabling cardio-pulmonary conditions was necessary before allowing research subjects onto the various treadmill and aerobic exercises. The original purpose was screening for eligibility to take part in the experiments, not to develop a separate line of research. But nevertheless this happened.
One day Dr. Haldorsen noticed that all the persons who listed mild asthma as a childhood condition, but not adult condition, also had higher systolic and diastolic blood pressure measurements than the average, the difference was 1.5 standard deviations.
Dr. H. mentioned this to the Office Director one day, and after a brief discussion about rights as a researcher agreed to pose the question of whether this was usable scientific data in its own right, serendipitously collected, or was it only screening data to be "discarded" once it had served that purpose. Before reading on, try to predict how the IRB ruled on this issue.
The IRB ruled that the data could not be used for publication. The reasoning was that the Informed Consent document specifically stated that the cardio-pulmonary health information was to be used to screen subjects not as research correlative information. In fact it was used to screen, and asthmatics were not chosen as subjects.
The IRB stated that Dr. Haldorsen should follow up on this line of research with Informed Consent that would make it plain to potential subjects that what the purpose of the new research was and why health history reporting was important. The IRB asked Dr. H. to conduct this new research with and without a screening procedure to see if the blood pressure measurements were contributing to an "anxiety response" which would be missed if participation were not hanging in the balance.
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