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Questions about litigation and human research puzzle ethicists
A 42-year-old woman came to the office of Louisville neuropsychologist Martine RoBards in 1999. Once the "star" of her workplace, a railroad mechanic shop, the woman now suffered insomnia, depression, anxiety, and memory loss. She had trouble organizing her thoughts and reciting her own history. The woman reported eight years of chronic exposure to mixed organic solvents used to clean engine parts. RoBards, who describes herself as a medical Nancy Drew, with help from a neurologist, made a diagnosis of chronic toxic encephalopathy caused by exposure to the solvents. She then set off to examine 92 of the woman's coworkers. Little did RoBards realize this small study would propel her on an 18-month odyssey. Eventually RoBards would help prompt a federal investigation into the University of Michigan's institutional review board (IRB), and of a team of UM investigators whose paper on toxic encephalopathy won a prestigious award.
The paper, financed in part by CSX Transportation, reported on a random and anonymous sample of rail workers who had sued CSX, alleging that the solvent exposure had caused them brain damage--solvent toxic encephalopathy. The UM researchers had obtained a waiver of informed consent from the university's IRB, as required by federal regulations, before using the worker's data, The principal investigator, James Albers, a professor of neurology and co-director of the neurobehavioral toxicology program, had originally examined the rail workers as an expert witness for the railroad company, and he and his colleagues performed a retrospective study on the results, which was then published. Albers also had received a $30,000 Sphere Award from Dow …