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Informed Consent Unnecessary in Blood Substitute Study

An Emergency Nurse in a teaching hospital with a Level I Trauma Center attends an in-service entitled “Updates in ED Treatment Protocols.” At the in-service, she is told that the hospital is participating in a multi-institutional study of PolyHeme, a blood substitute developed to save the lives of patients needing blood but for whom blood is not available.

She asks where she can find the consent forms for the study and is told that, as this is a study of critically ill trauma patients who are generally unable to give consent, a federal law says that consent is not necessary. The ED director explains that the study was approved by both the FDA and the hospital’s institutional review board (IRB).

According to the terms of the study, trauma patients will arrive at the ER already assigned to the conventional treatment arm (intravenous fluids in the field, followed by blood transfusions in the hospital as needed) or to the experimental arm (PolyHeme in the field, to be continued for the first 12 hours in the hospital as needed). The nurse is concerned about hanging PolyHeme in the ED for patients who haven’t consented, particularly when real blood is easily available and is the standard of care. When she raises the question, she is again assured that the IRB has approved the study.

Do her concerns have merit?

Also: Tissue issue, Prisoners in medical research.

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Published: Friday, December 1, 2006
Filed Under: Case Study, In the News, Principles of Bioethics
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