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The Pyrenean ibex, an impressive mountain goat that lived in the central Pyrenees in Spain, went extinct in 2000. But a...
Tight budgets are forcing NASA to consider turning off one or more planetary science projects that have completed their...
Ebola is not a stranger to West Africa—an outbreak in the 1990s killed chimpanzees and sickened one researcher. But the...
In an as-yet-unpublished report, an international panel of geoscientists has concluded that a pair of deadly...
Tropical disease experts tried and failed before to eradicate yaws, a rare disfiguring disease of poor countries. Now,...
Since 2002, researchers have reported that agricultural communities in the hot and humid Pacific Coast of Central...
Balkan endemic kidney disease surfaced in the 1950s and for decades defied attempts to finger the cause. It occurred...
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Duke Resumes Clinical Studies
17 May 1999 7:00 pm
After a 4-day shutdown by the federal government, the Duke University Medical Center in Durham, North Carolina, has been given a green light to start enrolling patients in clinical trials once more. The Office of Protection from Research Risks (OPRR), an agency at the National Institutes of Health that safeguards the treatment of patients in research, suspended federal support for clinical studies at Duke on 10 May because it found "severe deficiencies" in methods of filekeeping and protocol review (ScienceNOW, 12 May 1999).
The university's chancellor for health affairs, Ralph Snyderman, and a team of managers responded rapidly. They put together a plan to fix the problems OPRR had identified, rushed it to OPRR's offices in Bethesda, Maryland, last week, and persuaded the agency to end the shutdown.
Although OPRR fully restored Duke's research authority, it imposed some new conditions on the university. In a letter to Snyderman released on 14 May, OPRR enforcement officer Michael Carome writes that Duke must submit a complete list in 2 weeks of all trials that were suspended and, after that, file quarterly reports on its progress in improving the oversight of clinical trials. In addition, Duke has agreed to re-review more than 200 clinical protocols that were approved earlier this year under conditions OPRR judged to be "inadequate." The repeat reviews could take several weeks to complete, according to one researcher at the medical center, and may prevent some studies from returning to normal until June.