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: FSU College of Law Library Blog

Polyheme

By jlutz99

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Polyheme is a blood substitute. It has been used in clinical trials with trauma patients. While federal regulation requires the consent of subjects for clinical trials the regulation also allow a waiver of consent in certain cases which includes times in which the patient may be incapacitated and unable to give consent. The relevant rule is 21 CFR 50.24. Polyheme can save lives, but some ethical concerns have been raised. Ambulances do not carry blood but some do carry polyheme which can be administered to a critically injured patient. However in a recent study it was revealed that many of the subjects that received polyheme at the location of their accident continued to receive polyheme even after they got to the hospital where a blood transfusion was available.
Read more below, both from the American Journal of Bioethics:
An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme Trial-(Abstract Only)
Letter to the Editor: Emergency Research Consent Waiver - A Proper Way

Posted by Jon Lutz

Full post as published by FSU College of Law Library Blog on June 20, 2006 (boomark / email).