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 the IRB.
In both the Johns Hopkins and NIH cases, the researchers were experienced clinical researchers. But clinical research requires specific training--not just how to test hypotheses, but how to deal with the complicated jumble of federal requirements for human research. "While there is great satisfaction that comes from being on the front edge [of research] and actually being able to bring patients into a trial and see a new therapy work, the compliance ...
