Citing lax safety and oversight procedures, a federal agency has suspended nearly all government-sponsored research involving humans at the Duke University Medical Center, one of the nation’s top locations for clinical research.
The punishment, imposed last week by the federal Office for Protection from Research Risks, threatens a significant portion of the $175-million in federal grants that the center received this year for medical research. The sanction also jeopardizes some studies conducted at institutions with which Duke collaborates, including the University of North Carolina at Chapel Hill.
Duke officials characterized the problems as administrative lapses. “We have every intention of fulfilling the corrective actions they requested of us; we will do everything we can to work with O.P.R.R. to gain their approval and confidence,” said Ralph Snyderman, dean of Duke’s medical school and chancellor for health affairs at the medical center. “We believe with all our hearts and our brains that we do among the finest clinical research in the world, and we want to get back to what we do best.”
This is only the fourth time in 10 years that the research-protection office has suspended an institution’s federal license to conduct human research. The action came after the office concluded that Duke’s medical center had failed to correct more than 20 deficiencies in its system for protecting human research subjects.
Many of the infractions may be common at research universities around the country, according to recent studies.
The problems involved Duke’s institutional review board, or I.R.B., a group of campus officials and scholars who oversee research on humans. In June, the Inspector General of the Department of Health and Human Services issued a report on review boards nationwide specifying instances of conflicts of interest and inadequate training -- two of the deficiencies found at Duke. Similar lapses were identified in a 1997 report by the federal General Accounting Office.
Among the problems cited by the research-protection office was a failure by Duke’s review board to monitor studies once they had begun. Such monitoring is the primary means of insuring that human subjects are not unexpectedly harmed by the research, explain federal officials. The review board was also criticized for having failed to insure that studies involving children included the safeguards required by federal regulations.
The research-protection office also found that the review board had failed to comply fully with federal conflict-of-interest rules. The membership of the Duke medical center’s review board included the director and the assistant director of the university’s Office of Grants and Contracts, which is responsible for bringing in grants.
Investigators from the federal agency first identified problems at Duke in December 1998, during a random site visit. After follow-up visits and several exchanges of letters, federal officials say Duke’s medical center still had not made the prescribed corrections. That, in turn, “suggests a failure of leadership in D.U.M.C.'s human subject-protection system,” wrote Michael A. Carome, chief of the agency’s Compliance Oversight Branch, in a letter of suspension to Duke.
“Research activities involving previously enrolled subjects may continue only where it is in the best interests of individual subjects,” he added.
Dr. Snyderman said none of the study participants had been put at risk by the deficiencies. But Gary B. Ellis, director of the research-protection office, said the problems were serious nonetheless.
It was the second time in two months that Mr. Ellis’s office had suspended research at a medical facility. In March, federal investigators did so at a Veterans Administration hospital affiliated with the School of Medicine at the University of California at Los Angeles (The Chronicle, April 2).
In recent years, the research-protection office has come under fire, from Congress as well as from patient groups, for its perceived failure to enforce the federal regulations designed to protect human research subjects. Some observers say its actions against Duke are part of an attempt to prove to lawmakers that the office is up to its oversight task.
The office has given Duke until June 1 to take corrective actions. Duke officials met last week with federal officials in Rockville, Md., to outline those efforts.
“We hope to get this resolved in a matter of days,” Dr. Snyderman said.
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Section: Government & Politics
Page: A35