An article in today's Washington Post has given me pause. A 50 million dollar, 5 year project, will allow researchers to conduct medical experiments without first getting patient consent. Granted the experiments will be on trauma victims and consent is hard to get, if not impossible, because most trauma victims are unconscious, this still seems to go against ethical principles.
Funding is coming from The National Institute of Health, with approval from the Food and Drug Administration, while the studies are being conducted by Resuscitation Outcomes Consortium.
The first experiments, involving nearly 6,000 patients, involve patients 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, emergency medical workers are randomly infusing some patients with "hypertonic" solutions containing much higher levels of sodium, with or without a drug called dextran. Animal research and small human studies have indicated that hypertonic solutions could save more lives and minimize brain damage.
The next experiment, which will involve about 15,000 patients, is designed to determine how best to revive patients whose hearts suddenly stop beating. About 180,000 Americans suffer these sudden cardiac arrests each year.
Emergency medical workers often shock these patients immediately to try to get their hearts started again. But some do a few minutes of cardiopulmonary resuscitation first. Researchers want to determine which tactic works better by randomly trying one or the other -- both with and without a special valve attached to devices used to push air into the lungs during CPR. That study is expected to start next month.
How have approvals of new treatments been conducted in the past? I know if I, or a loved one, was in an emergency situation I would not want to be subject to a new and experimental treatment without my consent. What if the new treatments fail or cause damage; will someone be held responsible?
Research will be done in the following cities: Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and Ottawa, and in Iowa and British Columbia.
I took an Ethics class in college and this seems very unethical to me, what are your thoughts?