Informed consent documents had been present, explained, and signed by all the participants in Eunice Browning's research at Memorial Hospital. The first data from the test of Formula #19 and Formula #33 topical anesthetics had been collected. The study was an elaboration of prior trials conducted by the Medical staff under the Chief of Medicine's auspices. The hypothesis was that there would be no appreciable difference in discomfort from IV insertion after application of either of the topical anesthetics. The Hospital's own tests, which were based on reports of one test per patient, confirmed the literature from the pharmaceutical clinical trials of the FDA. Browning's test was to be based on at least three separate IV insertions per patient, in other words, long-term patients.
Two days after the first round of using Formula #19 one patient developed an uncomfortable rash of the skin on the arm in which the IV was introduced. One day after that another patient developed a similar rash. What should Browning have done?
Correctly, Browning notified the Hospital of the adverse reactions. Correctly, Browning re-reviewed the trials and Hospital test literature on the subject to see what level of incidence of rash could be expected. It turned out to be about 5% of all cases tested in the FDA recognized clinical trials. Two cases among the 20 or so patients in Browning's study amounted to about 10% incidence of rash ... twice the rate, albeit in a very small study. Although the Hospital initially resisted it, Browning provided each patient who had signed a consent form with an Update Notice, stating the unexpected result of the first applications of Formula #19. Since patients did not know which Formula of anesthetic they were receiving, each was given the opportunity to withdraw from the study. Browning collected a signed copy of her notice from each patient. In the aftermath Browning realized that her first consent document was missing the risk information that she later found.
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