Clinical research consent: “Support” study

Ethics & Health Law News today highlights litigation which had been underway in the United States, which has been dismissed on a strike out application for lack of sufficient evidence that the clinical trial in fact caused injury to the prematurely born infants on the balance of probabilities.

The strike out decision in Looney v Moore did not decide whether the consent form for the trial was adequate. Dr Drazen & others writing in the New England Journal of Medicine assert that the consent form was adequate, even though it referred only to possible skin breakdown at the site of a pulse oximeter used to determine the premature infants’s oxygen saturation levels (within a certain range). The authors stated that (at the time):

… there was no evidence to suggest an increased risk of death with oxygen levels in the lower end of a range viewed by experts as acceptable, and thus there was not a failure on the part of investigators to obtain appropriately informed consent from parents of participating infants. Through hindsight (and essentially faulting investigators for not informing parents up front of a risk later uncovered by the trial itself), the OHRP investigation has had the effect of damaging the reputation of the investigators and, even worse, casting a pall over the conduct of clinical research to answer important questions in daily practice.

The litigation history was the subject of some comment in an article in the New York Times.

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