Government approves medical experiments performed on patients during emergencies without the consent of the patient or the family.
The studies are being conducted by the Resuscitation Outcomes Consortium, a network that includes medical centers in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and Ottawa and around Iowa and British Columbia.The federal government has given approval to this ambitious study which is going to create more controversy at the same also necessary to help patients in the near future. They will allow the researchers to conduct medical experiments without getting patient’s approval or families consent.
The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.
The organizers for these studies say it will help them to find better ways to resuscitate people whose hearts suddenly stop, stabilize patients when they go into shock and minimize damage from head injuries. Since these patients are unconscious and time is of the essence it is not possible for them to get consent from families, so the organizers say, they need to be experimented as quickly as possible otherwise death is imminent.
The project has been endorsed by many trauma experts and some bioethicists, but others question it. The critics say the research violates the basic fundamental ethical principles.
The harshest critics say the research violates fundamental ethical principles.
The organizers said the studies have been approved after the National Institute of Health had thoroughly reviewed their studies and authorized their funding in 2004. The Food and Drug Administration have also approved the first phase about a year ago and the second phase six months ago.
The first experiments, involving nearly 6,000 patients, focus on people who are in shock or have suffered head injuries from a car crash, a fall or some other trauma.
About 40,000 such patients show up at hospitals each year, and the standard practice is to give them saline infusions to stabilize their blood pressure. For the study, the emergency medical workers want to give them “hypertonic” solutions containing higher levels of sodium, with or without a drug called dextran. Previously this study has been conducted on animals and small studies done on humans have shown they can save more lives and minimize brain damage.
The next experiment will involve 15,000 patients and the study is designed to determine the best way to revive those whose hearts suddenly stop beating like the Cardiac arrest cases. Nearly 180,000 Americans suffer this cardiac arrest every year.
Emergency workers try either a shock treatment or cardiopulmonary resuscitation first; the researchers want to know what is effective, a shock treatment first or resuscitation first? This study is expected to start next month.
"We will never know the best way to treat people unless we do this research. And the only way we can do this research, since the person is unconscious, is without consent," said Myron Weisfeldt of the Johns Hopkins University School of Medicine, who is overseeing the project. "Even if there are family members present, they know their loved one is dying. The ambulance is there. The sirens are going off. You can't possibly imagine gaining a meaningful informed consent from someone under those circumstances."
Before they do this research however, they will organize a community consultation process (via public meetings, telephone surveys, internet posting, advertisement etc.) to see whether every one agrees, if they refuse to participate they will be given a special bracelet.
The project proceeds only after also being vetted by a set of local independent reviewers known as an institutional review board. Another group of independent advisers known as a data safety monitoring board will periodically review the study for any signs of problems.Despite this thorough review, other similar projects have been criticized heavily in the past. A Study testing a blood substitute called PolyHeme was criticized for putting patients at risk without consent.
FDA had to review the whole process because of the criticisms, not known what the current status of this project is.
"The ethics and policy concern is how you balance the streamlining of research to get the best information to treat patients against the moral imperative to get consent," said Nancy M.P. King, a bioethicist at Wake Forest University School of Medicine. "The emergency consent exception is supposed to carve out a very narrow window. What's been happening is that narrow window seems to be expanding."
The bioethicists such as Arthur Derse at the Medical College of Wisconsin, say the new research is more ethical than those that were done in the past. Most patients who receive the existing treatments do not survive, so they say trying newer methods is not a bad idea, some may save more lives. Without trying them we will not find out an effective method.
But others says consent is necessary before they do this, however trying to find out the family members on time will make this study impossible and help the patient in a timely manner.
"This just seems like lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible," said George Annas, a Boston University bioethicist. "I don't think we should use people like this."
Annas was particularly disturbed that children as young as 15 might be included in the research. Annas say one cannot experiment with a human’s life, if the treatment is done for all then they should do it for that child, if not they shouldn’t experiment it.
Others are concerned patients may be getting experimental therapies that could turn out to be inferior to standard treatments.
"The most promising experimental medical interventions have often been shown to be less effective than standard treatment," said Kenneth Kipnis, a University of Hawaii bioethicist.
The informing of community consultation process has also been criticized, that most of the time this process only tells what it is going to do rather than listening to the inputs of the community, so it is mostly one way communication not collaboration.
Weisfeldt at Johns Hopkins said the critics will be unhappy under any circumstances.
"Some people object to the whole concept of doing any study whatsoever without permission," Weisfeldt said. "We try to explain all the layers of approval we've gone through and that this is the only way we can do the kind of research that could save many more lives in the future.
Trauma accidents require immediate attention and decision, so they cannot get the consent necessary in time, but I understand the critics point also where they don’t want to be used as a Guinea Pig. Unless they educate us more, this kind of research will be a hard sell.
What is your view, will you consent to this research?
Ref:
Chron.com
