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Duke Medical Center to Resume Research Studies

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Duke Health News 919-660-1306

DURHAM, N.C. -- The federal Office for Protection from Research Risks (OPRR) Friday lifted the temporary suspension on the Duke University Medical Center's (DUMC) ability to conduct research involving human subjects, medical center officials announced.

In a letter to Dr. Ralph Snyderman, chancellor for health affairs, Dr. Michael A. Carome, chief compliance officer for OPRR, said: "OPRR has determined that DUMC has developed the satisfactory corrective plans that were required in OPRR's letter of May 10, 1999. ...OPRR hereby reinstates the Duke University Medical Center Multiple Project Human Subjects Assurance (MPA M-1106) ... effective immediately ... for all federally supported research involving human subjects at DUMC. The MPA will retain its previous expiration date of December 31, 2001."

Snyderman said he was "extremely grateful that the hard work" of Dr. Edward Holmes, dean of the school of medicine, and the Institutional Review Board task force have been recognized by OPRR.

"More importantly, I am pleased, as I know our faculty and members of our research community will be, that we can ensure all participants in DUMC research projects that their health and safety continues to be our highest priority. We are grateful to OPRR officials for their assistance in helping us work through the necessary steps that have enabled us to resume the important work being done by our faculty and our IRB," said Snyderman.

DUMC officials were notified Monday by OPRR that all studies involving human subjects that did not have therapeutic benefit to patients should be suspended.

On Thursday, a team of DUMC officials led by Snyderman and Holmes met with OPRR officials in Maryland and reviewed with them the corrective actions DUMC planned to take to ensure compliance with federal regulations. Late Thursday afternoon, DUMC submitted a revised plan for corrective action based on the discussions earlier in the day.

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