Research suspension at Johns Hopkins

Abstract

It has been a hot summer at Johns Hopkins University in Baltimore, and it seems the heat is likely to last for a while. The problems started with the tragic death of a 24-year-old research technician, who volunteered to participate in an asthma research project. She was hospitalized on 7 May 2001, the day after inhaling the test drug hexamethonium, and died on 2 June from lung failure. Two other subjects in the same study had a mild response to the drug or showed no adverse reaction at all. Shortly after the tragedy, Johns Hopkins proclaimed that a review board had approved the study in which the volunteer died and ‘hexamethonium has been used in several studies involving lung physiology… without any unexpected adverse effects’. However, on 16 July, they accepted full responsibility for the tragedy after a Hopkins investigating committee concluded that the institutional review board had not fully appreciated the safety risks of hexamethonium. Three days later, the Office for Human Research Protection, a federal agency, announced that they had reached the same conclusion. As a consequence, the agency suspended all federally financed medical research involving human subjects until the university had taken appropriate measures. Four days and many angry words from Hopkins officials later, the agency eased the suspension – but only under strict conditions. Most of the thousands of studies that were suspended have to undergo another round of review by panels of the university and the agency. A delay of weeks or months is expected. J.d.B.