Monday, May 28, 2007

Human Experimentation Without Consent

I find myself feeling ambivalent about this story: Permission has been granted to therapeutically experiment on trauma victims and people whose hearts suddenly stopped beating, toward the end of improving care in such medical emergencies. In the past, I have opposed using unconscious and dying patients in medical experiments not intended to benefit them because I perceived it as treating them as objects rather than subjects. But these proposed experiments are different, e.g., they are intended to help the person experimented upon as well as those who will later benefit from the knowledge thereby gained. From the story:

The studies are being conducted by the Resuscitation Outcomes Consortium, a network of medical centers that do research in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and Ottawa, and in Iowa and British Columbia.

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.

"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 L. 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."

The methodology and oversight are to be taken by Institutional Review Boards (IRB). I am not one who necessarily trusts this system, but so long as none of the methods undertaken on these unconscious patients is known to be less efficacious than current methods, and so long as preliminary research indicates that the experimental methods are more beneficial than current methods, such experiments may be the only way to learn what these researchers seek. If consent can be readily obtained, of course, it should be. But if not, in a suitable emergency, it seems to me that such experimentation does not treat these patients instrumentally, but in fact, just the opposite.

I am willing to be convinced otherwise, however. And if abuses pop up, those responsible should be dealt with in the most strict fashion.

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2 Comments:

At May 28, 2007 , Blogger Tony Jones said...

I agree that experimenting on people without their consent is generally wrong.

However, isn't it generally acceptable to revive people if it is not known whether or not they have a DNR order? So why can't other life-saving measures be taken if the patient's wishes are unknown? It's totally different from organ transplants with unconscious patients who may or may not be brain dead.

 
At May 29, 2007 , Blogger Lydia McGrew said...

One question I would have is this: Is it plausible that the emergency workers themselves have individual opinions about which method is best? I'm thinking especially of CPR vs. shocking. Now, I'm willing to admit that those opinions are likely to be based on anecdotal evidence from their own experience. But I'm a little concerned about telling these people to set aside their own beliefs about the best way to treat the patient in front of them and instead to go by the numbers so as to do random trials of different methods of treatment. Are they really likely to be at such a "flip of the coin" point in each case? Might not individual cases have indications that one method or the other would be better? But in a study those would have to be ignored. That's where my concerns lie.

 

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