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Blood tests conducted without consent

Published February 20, 2004

CHICAGO (AP) — Paramedics are testing an experimental
blood substitute on severely injured patients without their consent
in an unusual study under way or proposed at 20 hospitals around
the country.

The study was launched last month in Denver and follows similar
research that was halted in 1998, when more than 20 patients died
after getting a different experimental blood substitute.

Supporters say the current product, PolyHeme, made by Northfield
Laboratories of Evanston, Ill., is safer and could save many of the
nearly 100,000 people who die of bleeding injuries each year
nationwide.

“It could revolutionize how we take care of resuscitation
in the United States and across the world,” said lead
investigator Dr. Ernest Moore, chief of trauma surgery at Denver
Health Medical Center.

The research is part of a race to find what doctors call the
holy grail of emergency medicine: a product that works like human
blood to save victims of car crashes, shootings or other trauma but
could be carried in ambulances and given to people of any blood
type.

Patients will be randomly selected to receive PolyHeme
intravenously or standard saline solution at the scene or en route
to the hospital.

Because severely bleeding trauma patients often are unconscious
or in shock, they are unable to give the consent required for
experimental treatment. As a result, the researchers in this case
are being allowed to bypass the consent rules under a 1996 federal
exemption that applies to emergency, potentially lifesaving
research.

The exemption requires the research to be publicized beforehand
in communities where the study will be conducted, both to let
people opt out if they are ever injured and to give the community a
chance to express any objections. In effect, the community
briefings are used to obtain consent.


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