The death of a healthy 24-year-old woman who received US$365 to participate in asthma-related research has again raised questions about how adequately medical research participants are informed and protected. The research at the Johns Hopkins Bayview Medical Center in Baltimore, where Ellen Roche worked as a laboratory technician, was suspended just before her death June 2.
Researchers induced asthmatic reactions in people without asthma to study the possible protective physiologic mechanisms of deep breathing on normal lungs. In the baseline physiologic test, Roche and 2 other volunteers inhaled hexamethonium, a ganglion blocker that disables the protective mechanism of lung relaxation induced by deep breathing.
Roche signed an informed-consent form that warned of possible wheezing, chest tightness and temporary difficulty in breathing. Within a month of inhaling hexamethonium, she died of acute respiratory distress syndrome and renal failure.
The initial investigation by the Office for Human Research Protection found that researchers had violated safety procedures by failing to report a previous adverse reaction, failing to get Food and Drug Administration permission for the subjects to inhale hexamethonium and failing to inform volunteers that they were inhaling an experimental, unapproved drug.
Since 1998, concerns about patient safety have halted clinical trials at medical schools at universities in Oklahoma, Alabama, North Carolina and Massachusetts. The death of 18-year-old Jesse Gelsinger (CMAJ 2001;164[11]:1612) during a gene-therapy trial in September 1999 led the University of Pennsylvania to stop using human subjects in its genetic research. The investigation into Roche's death continues, but in July the Office for Human Research Protections suspended almost all federally funded research at Johns Hopkins. The office ruled that the ethics committee that had approved the study involving Roche had failed to take proper precautions to protect its subjects. However, the suspension lasted only 4 days, and was lifted July 23.