Ban lifted on U.S.-funded human experiments at Duke

University officials agree to correct safety violations


A 4-day-old ban on federally financed human experiments at Duke University Medical Center was lifted yesterday after Duke officials agreed to overhaul its protections for human subjects.

Duke's license to conduct research on humans was suspended Monday, after the federal Office of Protection From Research Risks found 20 violations of ethics and safety rules at the Durham, N.C., university and said Duke had failed to correct them over three months.

Gary Ellis, chief of the ethics office, said yesterday that Duke officials, who flew to Washington to meet with him Thursday, had presented a "satisfactory corrective action plan."

"We will monitor Duke closely over the next year or so to make sure the plan is fully implemented," he said. "This is the beginning for Duke, not an ending."

University officials said they were pleased with the decision and promised to strengthen the center's protections of human subjects, starting with an overhaul of its Institutional Review Board, the body that reviews each proposed human experiment at Duke.

"We know action is required of us now, but we are now committed to developing a model IRB program," Dr. Edward W. Holmes, dean of the School of Medicine at Duke, said. "It will make the university stronger."

He acknowledged that the resolution produced yesterday could and should have come months earlier, but "the important point now is to look forward."

Under Duke's plan, the university will have to make a complete review of at least 274 experiments that had been approved by the IRB, Holmes said, and possibly more. It will have to retrain and educate each member of the review board and put all experimenters who work with human subjects through more training.

Ellis said, "Four months of denial by Duke University Medical Center of inadequacies in human subject protections finally ended this week. It is our experience that some programs that have had problems like this in the past have later become the best centers in terms of protection. That could well be the case with Duke."

Thomas Puglisi, at OPRR, said he believed that the most important part of Duke's new plan is extensive plans to educate review board members and scientists. They will not only take courses, but attend national conferences on human experimentation and have regular lectures on human experimentation and the federal rules that govern it.

Late last year, the OPRR decided to visit Duke University and conduct a routine examination of its system for reviewing and approving human experiments. There are about 2,000 such experiments there now, ranging from the testing of new drugs and medical devices to research aimed at improving patients' abilities to deal with illness.

The OPRR, an agency of the Department of Health and Human Services, monitors all human experiments carried out with federal financing around the nation.

Its team visited Duke in December at least partly because Duke was the only one of the top 15 research universities that it had not heard from for years. Most universities periodically call with questions or to ask for advice.

Pub Date: 5/15/99

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