An open letter to institutional review boards considering northfield laboratories' polyheme® trial

American Journal of Bioethics 6 (3):18 – 21 (2006)
  Copy   BIBTEX


At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.



    Upload a copy of this work     Papers currently archived: 91,322

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Letter to the Editor: In Defense of the PolyHeme® Trial.Anne Hamilton Dougherty - 2006 - American Journal of Bioethics 6 (5):W35-W37.


Added to PP

30 (#517,657)

6 months
7 (#425,192)

Historical graph of downloads
How can I increase my downloads?