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Consortium aims to improve protection of human research subjects

DURHAM, N.C. - A national "Consortium to Examine Clinical Research Ethics" (CECRE) has been established at Duke University Medical Center to compile the first comprehensive information about oversight of clinical trials at medical centers, and to develop new ways to protect people enrolled in such trials.

The founding of the center -- funded by an $830,000 grant from the Doris Duke Charitable Foundation -- comes amidst a mounting demand for better procedures to inform research subjects of the risks of taking part in clinical trials of drugs and other treatments, said the center's participants. Also, they said, new oversight might be needed since some medical researchers have been criticized for conducting trials of drugs produced by companies in which the researchers have a financial interest.

The multidisciplinary CECRE group includes clinical researchers, industry representatives, Institutional Review Board (IRB) members and bioethicists from across the nation. Institutional Review Boards are those committees in medical centers charged with local oversight of research involving human subjects.

"The system to protect participants in clinical research recently has been challenged," said Dr. Jeremy Sugarman, director of the Center for the Study of Medical Ethics and Humanities at Duke University Medical Center. Sugarman cited as key events sparking such challenges, the deaths of several research participants at medical centers in Maryland, Pennsylvania and New York over the last few years.

"Concern has focused on financial conflicts of interest, the workings of the IRB and haphazard reporting of such adverse events as drug reactions," said Sugarman. "CECRE should provide unique data and proposals that will shape discussions and public policy for years to come."

The consortium will be led by Sugarman, Dr. Ezekiel Emanuel, chair of Clinical Bioethics at the National Institutes of Health; and Dr. Angela Bowen, pres
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Contact: Richard Puff
richard.puff@duke.edu
919-684-4148
Duke University Medical Center
24-Jan-2002


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