The CEO of Johns Hopkins Medical Institution admitted the hospital's responsibility in the death of a 24-year-old study participant. Ellen Roche was an otherwise healthy woman when she voluntarily enrolled in Hopkins' study of irritants that cause asthma.
As part of the study, Roche was given one gram of hexamethonium, a blood pressure medication known to constrict airways. One day later she developed a dry cough. Three days after inhaling the drug she experienced difficulty breathing, followed by a fever exceeding 100 degrees. She soon died.
An investigation of the study revealed several problems. Vital information regarding the study was kept from the institutional review board that oversees tests involving human subjects. The board was unaware of earlier studies that linked hexamethonium to severe lung damage. Additionally, the researchers added sodium bicarbonate to the test drug without authorization from the board.
Hopkins is now implementing procedures to prevent similar incidents. A thorough evaluation of the institutional review board is ongoing and a new review board will be created to handle the increasing number of studies.