(The following article by James Bruggers appeared in the Louisville Courier-Journal.)
LOUISVILLE, Ky. — The University of Michigan failed to document why it allowed doctors to use medical records from railroad workers in research without the patients’ permission, federal investigators have found.
”Documentation shows that the process of thinking through the decision (to waive consent rules) actually took place,” said Pat El-Hinnawy, spokeswoman for the Office of Human Research Protections, a watchdog arm of the U.S. Department of Health and Human Services.
Paul Simmons, an ethics expert at the University of Louisville School of Medicine, called the breach ”a major violation” of research subject rights.
The research protections office has ordered the university to submit a corrective action plan by March 31. It also has told university officials to respond to three other undisclosed concerns by the end of the month, saying its investigation remains open.
Potential sanctions range from a letter of reprimand to shutting down a university’s entire research program.
Complaints from Louisville neuropsychologist Martine RoBards and as many as 17 railroad workers, including some from Kentucky, triggered the federal inquiry.
The inquiry followed a 10month investigation by The Courier-Journal, published in May 2001, which found that CSX Transportation had paid nearly $35 million to more than 460 railroad workers from Kentucky, Tennessee, West Virginia, Maryland and elsewhere. Doctors had diagnosed brain damage in the workers caused by occupational exposure to solvents.
The Michigan medical team had been hired by CSX to conduct research using some workers’ medical records and to help the company defend itself against lawsuits. Workers who wanted to proceed with their claims were required to see the Michigan doctors, led by neurologist James Albers.
The university is preparing its response to the federal agency and will make it available to the public after it is submitted to the government, said its spokeswoman, Kara Gavin.
She said school officials, including Albers, were declining to comment until then. Gary Sease, a spokesman for CSX, said, ”We saw the letter and we think that is a matter between the agency and the university.”
A university investigation in 2001 found that Albers and his team should have been more forthcoming about their financial relationship with CSX, but found no evidence to suggest that the doctors should have obtained workers’ permission before doing their research.
CSX paid more than $170,000 over two years for the Michigan research. When published, it denied a link between industrial solvents and brain damage in the company’s workers, despite diagnoses to the contrary by other physicians. CSX’s payments were in addition to undisclosed sums paid to the researchers for private consulting work.
The two studies under review by the federal agency were published in 1999 and 2000 in the Journal of Occupational and Environmental Medicine.
In its Feb. 12 letter to the university, the review board did not address the relationship between the railroad company and the researchers. But the board found that the university’s medical school Institutional Review Board did not show that it had considered the following before granting the waiver:
–The research involved no more than minimal risk to the patients.
–A waiver would not adversely affect patient rights and welfare.
–The research could not be carried out without the waiver.
–The subjects would be provided with ”pertinent” information after participation.
That research subjects be fully informed and grant their permission are cornerstones of medical ethics, said Simmons, a professor who serves on three local ethics committees. And careful consideration of the four provisions mentioned by the board is central to ensuring research subject rights, he said.
”For what it is, this is a good finding,” said RoBards, who has been assisting a new group of railroad workers in lawsuits against CSX.
She said the workers whose records were used in the research never would have participated willingly.