Litigation and Human Research Ethics

Litigation and Human Research Ethics Scientist

VERACARE:
An Alliance for Human Research Protection--in- formation
Tel: 212-595-8974 FAX: 212-595-9086
veracare@rcn.com
Mon, 23 Jul 2001

FYI

An article in the current SCIENTIST about conflict of interest and betrayal of trust in medical research sheds light on yet another unethical research scenario that can be directly attributed to

the unholy alliance between academia and industry, and
the absence of explicit Federal protections against harm caused by retrospective research.

The details of this case were brought to public light in a series of investigative reports by Jim Bruggers, in the Courier-Journal in Louisville, Kentucky, beginning May 13, 2001.

Over 600 lawsuits have been filed against CSX Transportation by railroad workers from Tennessee, Kentucky, Ohio and elsewhere. The workers had been exposed for years to chlorinated hydrocarbon solvents, and now suffer from solvent-related toxic encephalopathy (brain damage). So far CSX has paid $35 million settlements.

The lawsuits were the impetus of a retrospective study, partially funded by CSX Transportation and Dow Chemical Corp. According to the SCIENTIST, a
team of University of Michigan (UM) medical researchers, headed by Dr. James
Albers, director of its Neurobehavioral Toxicology Program, examined 60 to
70 of the disabled workers. Then, using the information gained, they conducted a company financed retrospective study, in which these disabled workers were the subjects-- without their knowledge or informed consent.

The University of Michigan's Institutional Review Board twice granted the
researchers a waiver from informed consent. The published study was used by
CSX to refute the workers' legal claim for damages--but CSX was unsuccessful. To underscore the lack of meaningful protections under current Federal regulations, for ordinary people who are harmed by research, I cite the following statement by Jeffrey Cohen, director of education of the Office of Human Research Protection (OHRP): "If you have a category of people who could potentially be harmed [by the results], but you can't, through the research, link up to an individual, then the regulations are really silent about that."

The case demonstrates how academic researchers and the IRB gave precedence to the interests of industry over the interests of disadvantaged, non-consensual human subjects, and how Government fails to protect the public interest. I call this an example of a betrayal of
trust.

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Click here for the article in The Scientist.

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