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As part of the response to the rapidly growing concern over the safety of human research subjects in clinical trials, the National Center for Research Resources (NCRR) recently established a new position, referred to as “Research Subject Ombudsman,” within each individual General Clinical Research Center (GCRC) funded by the National Institutes of Health to aid in protecting these subjects. The role of individuals who occupy this position, as stated in a one-page document sent by the NCRR to the GCRCs, is to “assure such compliance and conduct as detailed in the IRB [institutional review board]-approved protocol to maximize patient safety.”
Although the specifics of the position, including its title, are left to …
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