This was a study that basically turned into a clinical trial when the processes were changed. Originally one drug was being studied but then the clinical investigator decided to compare 2 drugs and at that point patient consent was required, but they didn’t do it. The FDA wants a plan submitted to correct this type of action from happening again and the first plan was not sufficient.
Here we go with privacy and if you were a patient being treated in the ER room and given one of these drugs, would you not want the opportunity to say yes or no? The two drugs were randomly chosen and the patient information in the “ER trial study” was gathered and “risk” with the drugs was not explained to the patients. Two issues here with not knowing the facts, first was the clinical investigator and secondly the board of the hospital, maybe all should take a brush up course in privacy? BD
Oak Brook-based Advocate Health Care failed to obtain proper consent from emergency room patients before enrolling them in a clinical study, according to a warning letter from the U.S. Food and Drug Administration.
The letter to Advocate’s institutional review board is dated June 1 and was posted on the FDA’s website this week.
The research project involved emergency room patients undergoing intubation, an emergency procedure in which a tube is inserted down the throat to open the airway.
The study, conducted at Advocate Christ Medical Center in Oak Lawn, originally was designed to evaluate the outcomes for people whose doctors chose to administer a sedative called etomidate.
But in July 2007, the clinical investigator proposed that human subjects be randomly selected to receive one of two drugs, etomidate and midazolam.
The board approved the modification in September and allowed the clinical investigation to continue without lifting the waiver on obtaining informed consent.