Researchers are currently testing an artificial blood on unconscious patients and this is creating an ethics debate. The artificial blood is called PolyHeme and is made by Northfield Laboratories. Ethicists have weighed in on both sides of the ethics question.
The artificial blood has been tested in earlier hospital studies and most have shown it to be safe. However, there was one study on PolyHeme that was halted after 10 of 81 patients given it had heart attacks and two died. None of those receiving standard treatment had a heart attack. Those who are concerned about the ethics of the current study have pointed out that no one is being informed of this study.
The research on artificial blood works this way. The community where the testing is to be done is informed by researchers about the study. Those who do not wish to be part of the study in case they have a serious accident can opt to wear a special bracelet. If paramedics see no bracelet, they open a sealed envelope that tells them to give either a standard saline solution or the artificial blood. The artificial blood continues to be given for 12 hours once the patient reaches the hospital. There are several ethics problems posed by the research. In the first place, the community is really not being well informed about the existence of the test on artificial blood.
In 1996 Congress passed a law that allows a bypass of the rules on informed consent when dealing with an emergency, potentially life saving research. Supporters point out that PolyHeme, the artificial blood, could save as many as 100,000 lives a year in the U.S. Dr. Richard Garnellie says we don’t ask permission to commence CPR and that the ethics of testing artificial blood falls in the same area. “We kind of have a social contract to do the right thing already.”
Kelly Fryer-Edwards who studies ethics at the University of Washington Medical Center says that it would be difficult to find people to volunteer for a study of trauma patients because people don’t like to think about being in an accident. However, she feels that the attempt has been made to get informed consent. “You’re putting the responsibility on the person who wants to opt outÃ¢Â?Â¦you have respected their autonomy by giving them that choice.” She feels that emergency research makes all approaches to research ethics go out the window-protecting subjects, getting informed consent.
Vera Sharaw, president of the Alliance for Human Research Protection is opposed to the research on artificial blood on ethical grounds. She says the study “is another one along that slippery slope that’s essentially demolishing your individual right not to become experimental subjects unless we give prior, voluntary, informed, comprehending consent.” She feels that the people who want to be in the study should be the ones wearing the bracelets.
Nancy King of the University of North Carolina has a third ethics concern. She agrees with those who support the experiment to use artificial blood in the field where blood can’t be typed. However she is opposed to its continued use for twelve hours after the patient has reached the hospital where it takes 20 to 30 minutes to type blood. She points out that giving human blood is the current standard of treatment once the patient reaches the hospital.
Several ethicists have pointed out that those most likely to be subjects of the research are from disadvantaged communities.
The University of California at San Diego School of Medicine has come up with the following questions for those interested in the ethics of research into artificial blood in emergency situations:
1. What ethical issues does this case raise for the process of informed consent?
2. Was the waiver of consent that exists for research involving emergency treatment appropriate in this case and if so, why?
3. From the community standpoint, who speaks for the interest of (potential) participants? Should more have been done to ensure their safety and well being and, if so, what?
4. In what circumstances, if any, is it ethically acceptable to draw a disproportionate share of its subjects from a disadvantaged community?
These are all good, difficult questions that should be answered by anyone interested in the ethics of giving artificial blood in emergency situations.