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OHRP Orders Johns Hopkins University to Suspend Human Subjects Research

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The Office of Human Research Protections (OHRP) effectively shut down all federally funded research involving human subjects at seven institutions of the Johns Hopkins University health system on July 19. This directive is the result of a recent investigation by the OHRP and the Food and Drug Administration (FDA) of circumstances surrounding the death of Ellen Roche, a healthy volunteer who died a month after inhaling hexamethonium as part of a trial studying asthma.

Although the drug in question had been approved for use before 1972 to treat hypertension, it was subsequently removed from use as more effective drugs emerged. It had …

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