IRB and Researcher held Responsible for Death of Volunteer
A Johns Hopkins panel is investigating the death of a 24-year-old woman in an asthma experiment. She most likely died from taking hexamethonium and the lead researcher and an internal oversight board that addresses safety lapses are being held responsible for her death.
Ellen Roche died from adult respiratory distress syndrome, a condition in which small air passages of the lungs break down and lose the ability to supply the blood with oxygen.
Her death is being blamed on "foolish" and "lazy" research techniques. It turns out that the Institutional Review Board at Hopkins' Bayview campus approved the asthma study after the lead scientist did not present sufficient evidence that the drug used in the experiment was safe. The consent form signed by the volunteers failed to disclose that the drug, hexamethonium, was no longer used clinically, lacked approval by the U.S. Food and Drug Administration and could cause severe side effects, even death. The FDA took the drug off the market in 1972, once it was found to be ineffective. It had been used as a high blood pressure medication during the 1950's and 60's.
The researchers and panel failed in conducting proper academic medical research. The lead researcher failed to search in several medical journal articles in the 1950's and 1960's that linked the drug to rare cases of fatal lung disease. The Hopkins committee also acknowledged that a routine search using Yahoo and Google, two popular search engines, would have produced a French medical school's web site that listed the past studies. Moreover, according to the investigatory panel, the review board should not have approved the study because the lead researcher did not present enough data demonstrating the safety of hexamethonium.
As of July 23rd Johns Hopkins reached an agreement with the federal government allowing research on human subjects to continue. The University is also in the process of developing explicit guidelines for literature searchers that will help researchers with future studies.
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