Research Project Title:	A Phase III, Randomized, Controlled, Open-Label Multicenter, Parallel Group Study Using Provisions for Exception from Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated) PolyHeme®] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting.
Study Purpose:	To evaluate the life-saving potential of PolyHeme® when given to severely injured and bleeding patients, starting at the scene of injury.
Principal Investigator:	David Hoyt, M.D. Professor of Surgery Director, UCSD Healthcare Trauma Unit
Study Sponsor:	Northfield Laboratories Inc.

  

UCSD and Scripps Mercy Hospital researchers are proposing to do this clinical study using an "Exception from Informed Consent" under federal regulation 21 CFR 50.24:   This regulation allows research to procede without obtaining the consent of the research subject when:

1. Patients are in a life-threatening situation requiring emergency medical intervention;
2. The currently available treatments are unsatisfactory;
3. Participation in the study could provide a direct benefit to the patients enrolled in the form of survival;
4. The risks are reasonable, and;
5. The research could not be conducted without an exception from informed consent regulations.  

Typically, patients who are severely injured and bleeding are unable to grant consent for treatment because of the nature and extent of their injuries.

Federal regulations only allow this type of research to be done when there has been consultation with community representatives to judge whether the research is consistent with ethical values and concerns of those who might become research subjects.

Links for information related to this study:

• Information about PolyHeme, the product being tested.
• Information about the community meeting to be held at UCSD Medical Center on August 6, 2003 at 7:30PM. (PDF format)
• Federal regulations about emergency research that is conducted without obtaining consent, that include the requirement for community notice and public review of the proposed research
• Frequently asked questions about the proposed study
• Provide us your opinion about the study:
• Feedback form in PDF format - fill it out and fax it back.
• Contact the Study Coordinator
• Contact the UCSD Human Research Protections Program

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