Protection of Human Research Subjects

Originally Published MDDI March 2002

R&D DIGEST

Adverse events during human clinical trials in the past few years, including the deaths of research participants in Maryland, Pennsylvania, and New York, have prompted increased scrutiny of current methods for safeguarding human subjects. "The system to protect participants in clinical research recently has been challenged," says Jeremy Sugarman, MD, director of the Center for the Study of Medical Ethics and Humanities at Duke University Medical Center (Durham, NC).

As part of an effort to develop new ways to protect patients enrolled in such trials, a national Consortium to Examine Clinical Research Ethics (CECRE) has been established at Duke to compile the first comprehensive database about the clinical trials conducted at U.S. medical centers.

The multidisciplinary CECRE group includes clinical researchers, industry representatives, institutional review board (IRB) members, and bioethicists from across the nation. The consortium will be led by Sugarman; Ezekiel Emanuel, MD, chair of Clinical Bioethics at the National Institutes of Health; and Angela Bowen, MD, president and chief executive officer of the Western Institutional Review Board.

The CECRE participants suggest that there is an increasing demand for better procedures to inform research subjects of the risks of taking part in clinical trials of drugs and other treatments. They further argue that 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.

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