A clinical trial that has been criticized for allegedly violating research ethics and Federal regulations is nearing completion. PolyHeme, an oxygen-carrying resuscitative fluid to treat uncontrolled bleeding, is in the final stages of a Phase III trial at some 30 Level 1 trauma centers in 18 states, and is expected to finish in the coming months."We are more than 90% finished. We are past 655 patients out of 720 and are still enrolling patients," said Sophia Twadell, spokeswoman for sponsor Northfield Laboratories of Evanston, Ill. "We expect to done by the end of June."The trial has drawn criticism from bioethicists because research subjects, who are in hemorrhagic shock at the time of the trial, are not required to give consent. The FDA approved the PolyHeme study in March 2003 under a 1996 emergency research waiver rule, which lays out a narrow set of circumstances under which Institutional Review Boards (IRBs)...
The ScientistThe ScientistarticlesAlden March Bioethics InstitutecolumnistThe ScientistThe ScientistThe Scientistguidancetagres@the-scientist.comClarification (posted May 18): When originally posted, the story implied that McGee and his colleagues had found equal rates of informing surrounding communities between Albany and other regions conducting the PolyHeme trial.http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1American Journal of Bioethicshttp://www.bioethics.net/journal/pdf/UAJB_A_166837.pdfhttp://www.bioethics.org/The Scientisthttp://www.the-scientist.com/article/display/23296/http://www.fda.gov/ora/compliance_ref/bimo/err_guide.htm
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