Consent form blamed in fatality at Johns Hopkins
A young, healthy woman who died after taking part in a Baltimore-based Johns Hopkins University asthma study was not fully informed of the risks involved, according to a committee formed to investigate the death. The committee filed a report with the federal government’s Office of Human Research Protection, in which it concludes that the informed consent form signed by 24-year-old Ellen Roche and other healthy volunteers was "inadequate" and "should not have been approved" by the Institutional Review Board (IRB).
Louis Becker, MD, a Hopkins professor of medicine who led the university’s internal review of the trial, said during a during a press briefing that the consent form should have made clear that hexamethonium, one of the drugs administered in the study, is not approved by the Food and Drug Administration (FDA) and is no longer in clinical use. The form also should have stated that hexamethonium delivered by inhalation, as it was in the study, "was only used experimentally, never clinically," and that serious adverse events or death were possible, he says.
The woman developed a cough after inhaling a gram of hexamethonium as part of the trial. Within a month, she died of progressive hypotension and multi-organ failure. The committee criticized the researchers and the IRB for other shortcomings, and it echoed a number of concerns raised by the FDA. The FDA cited Alkis Togias, MD, for what it says was a failure to disclose the woman’s unexpected reaction.
In addition, the FDA cited Togias for failing to seek the agency’s approval prior to conducting the clinical trial, as well as changing the study protocol without permission from the IRB. Togias did not return a call seeking comment.
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