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An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial.
- Source :
-
American Journal of Bioethics . Oct2010, Vol. 10 Issue 10, p5-8. 4p. - Publication Year :
- 2010
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CLINICAL trials & ethics
*HEMORRHAGIC shock treatment
*PHYSIOLOGIC salines
*BLOOD coagulation
*BLOOD transfusion
*BLOOD substitutes
*EMERGENCY medical services
*EMERGENCY medicine
*EXPERIMENTAL design
*HOSPITAL emergency services
*INFORMED consent (Medical law)
*LEGAL liability
*RESEARCH methodology
*PATIENTS
*RESEARCH ethics
*INSTITUTIONAL review boards
*HUMAN research subjects
*ETHICS
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 15265161
- Volume :
- 10
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- American Journal of Bioethics
- Publication Type :
- Academic Journal
- Accession number :
- 54419383
- Full Text :
- https://doi.org/10.1080/15265161.2010.519230