According to this article, and another one I read a few weeks ago, this is the an experiment.
Paramedics in five U.S. cities have started infusing experimental artificial blood into victims of car crashes, shootings and other life-threatening emergencies without first getting their consent, as most research projects require.
Ambulances and medical helicopters racing to bring hemorrhaging patients to more than a dozen other hospitals around the country, including possibly two in Virginia, will eventually join the test of the synthetic oxygen-carrying liquid, called PolyHeme.
Supporters say the study is the only means to prove that the pouches of red fluid offer one of the longest-sought tools in medicine
Critics, however, say the work is unnecessary and violates a fundamental ethical tenet of scientific research that protects people from becoming medical guinea pigs against their wishes.
"It's hard to think of any justification for ever doing research on any human subjects without their consent," said George Annas, a medical ethicist at Boston University. "That's a bedrock principle of human-subject research."
The case illustrates the collision of goals that occurs whenever researchers try to come up with new ways to save people in emergencies, when the most seriously injured are often unconscious or in shock and therefore unable to consent to an experimental procedure.
"Trials like this are unbelievably important," said Kenneth Kipnis, an ethicist at the University of Hawaii. "There is a lot of good that can come of studies like this."
The PolyHeme study is the latest of about 15 similar experiments that have been approved since 1996, when the Food and Drug Administration created a special category of research that eliminated the need for patient consent in specified circumstances so scientists could develop desperately needed emergency treatments.
"This study is exciting..."
Northfield is confident PolyHeme is safe and hopes to demonstrate that and its ability to save lives in the new study, which began in December and will involve 720 adults in shock from extensive blood loss. Half will get PolyHeme, and half will get saline. (Pregnant women and those with head injuries will be excluded.)
A family member will be contacted as soon as possible, however, to see if the patient may continue in the study.
Testing has begun in Houston; Denver; Memphis; Allentown, Pa.; and Newark, Del. Nearly 20 more hospitals will eventually join the study, and many are actively considering signing on, including Sentara Hospital in Norfolk and Virginia Commonwealth University Hospital in Richmond.
Before a hospital joins the study, it must get approval from its internal review board. That entails gauging each community's reaction to the study...
So far no center has decided against joining the study, Gould said.
But Nancy M.P. King, who teaches medical and research ethics at the University of North Carolina School of Medicine, has several reservations about the study...
Boston University's Annas argues the study could be designed to make consent possible...
...not if they don't want to be in the study...
...But in the cases of promising experimental emergency treatments such as PolyHeme...
"It really is the only way that we or anyone else believes this study could be done."
I don't think there's any question. This is an experiment.