In June, word leaked out that something terrible went wrong with a clinical trial at Johns Hopkins University. A healthy, 24-year-old employee of one of the clinics died while participating in a research study on asthma. Such negative events are not unheard of: in 1993, half the participants in a 10-person trial of the anti-hepatitis B drug, fialuridine (FIAU), carried out at the National Institutes of Health, died. Two others became severely ill.1
In the ensuing investigations of the Johns Hopkins study, it became clear that the researchers involved made errors: they used a drug no longer approved by the Food and Drug Administration for human use; they missed important research papers on the drug; their consent forms were incomplete; they changed the protocol for mixing the drug without consulting the Institutional Review Board (IRB), which has oversight for human research; and they delayed reporting other adverse responses to...
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