U.S. Rescinds Suspension of Research at Duke

U.S. officials, who on Monday halted clinical research at the Duke University Medical Center, lifted the suspension Friday in response to the prestigious teaching hospital’s extensive new plans to strengthen safeguards for people in studies.

The action, which reinstates the medical center’s license to do federally funded studies on people, allows Duke researchers to go back to work on most of the 2,000 projects that the abrupt ban threw into turmoil.

But 274 human studies remain on hold until a medical center ethics committee reevaluates them, said a hospital spokeswoman. And the Durham, N.C., institution is on probation with the federal body that took the action, the Office of Protection From Research Risks, according to a risk office letter dated Friday. Among the terms of Duke’s “restriction” is that the medical center must train research personnel on the human subject protection regulations, including obtaining and documenting informed consent, reorganizing the institutional review boards that evaluate the validity and ethics of studies, and filing periodic progress reports to the risk office.

Dr. Ralph Snyderman, Duke’s chancellor for health affairs, expressed gratitude to the risk office for working with university officials, and reassured study participants that “their health and safety continues to be our highest priority.”

The temporary suspension of Duke’s federal research license was a less severe sanction than the risk office action levied in March against the Veterans Affairs West Los Angeles Healthcare Center. The VA hospital’s federal research contract was terminated outright after the facility failed to correct problems in the oversight of clinical research after six years.

By contrast, the risk office first spot-checked Duke’s research procedures only last December, finding 20 deficiencies in areas such as documentation of informed consent and possible financial conflicts of interest on the institutional review board voting membership.

Some critics as well as Duke researchers said the risk office’s action was precipitous, imperiling tens of millions of dollars in research.

Industry spokesman Dr. Bert Spilker of the Pharmaceutical Research and Manufacturers of America said the risk office could have settled the matter without the chaos-causing suspension.

But Gary B. Ellis, the risk office director, said it was Duke’s “enduring unresponsiveness” to the problems described over the last four months that prompted the action. “This was a suspension that didn’t have to happen,” he said.