U.S. Suspends Clinical Research at Duke

U.S. officials have suspended clinical research activities at Duke University Medical Center--one of the nation’s top teaching hospitals--because of widespread administrative failures to follow regulations that safeguard people in studies.

Duke is the third major medical center in less than a year to receive such a severe sanction from the Office of Protection From Research Risks. In March, the regulators blocked research at the Veterans Affairs West Los Angeles Healthcare Center. That suspension, bolstered by the Department of Veterans Affairs in Washington, remains in effect.

Last fall, the risk office took similar action against the Rush Presbyterian Medical Center in Chicago. That research ban was soon lifted. In addition, the risk office last February restricted new drug addiction research at several clinics in the Los Angeles area that are coordinated by the Friends Research Institute, a nonprofit firm.

The action taken Monday to revoke the Duke Medical Center’s umbrella contract to do federally funded research on people bars researchers from enrolling new subjects in studies and threatens approval of future projects at the prestigious medical center in Durham, N.C. Patients currently taking part in research may remain involved if discontinuing would cause harm.

There was no evidence that research subjects have been physically injured, said Gary B. Ellis, director of the risk office. The suspension was a preventive step prompted by the medical center’s “systematic failure” to properly oversee clinical research, he said in an interview.

Dr. Ralph Snyderman, Duke’s chancellor for health affairs, said medical center officials were “firmly committed to providing participants in clinical studies with the utmost protection against research risks and intend to work closely with the [risk office] to ensure absolute compliance with federal requirements.”

The restriction placed on Duke grew out of a risk office review of clinical research at the medical center last December. At that time, a team of five risk office regulators and four consultants interviewed dozens of administrators and researchers, analyzed 50 studies and pored over the records of eight committee meetings at which about 1,000 research-related decisions were made. Numerous problems were identified, according to risk office letters obtained by The Times under the Freedom of Information Act.

In an eight-page letter to Duke dated May 10, the risk office said the university’s response to the findings was inadequate. It cited 20 violations of federal research policies and regulations.

Most problems centered on the medical center’s institutional review board, which evaluates clinical research projects for scientific validity and ethical practices.

Among the violations: apparently insufficient training of review board members to make the decisions at hand, potential financial conflicts of interest with some board members, meetings that included too few members for decisions to be valid and poor record-keeping in instances of changes in legally required informed-consent procedures.

The risk office chastised Duke for a “significant lack of progress” in addressing its findings since December, citing a “failure of leadership” in the university’s “human subject protection system.”

Duke officials voluntarily extended the research restrictions to all clinical research projects at the medical center, regardless of funding source, agreeing not to add any more human subjects to ongoing studies. Medical center officials indicated they would resubmit study proposals.