Know Your Rights! (Oh wait, you ain't got none)
Hollywood's fascination with all the terrible things Westerners do in Africa has always been a little cloying. Did anyone actually need to see Blood Diamond to get the point? Then there was The Constant Gardener, which melodramatized the all too real phenomenon of American and European drug companies finding it more expedient (if more ethically questionable) to do research on poorly educated and ill informed Third World subjects. Turns out, Hollywood could just as well have set their cameras on good old Seattle.
On Monday, a friend of Seattlest forward us this troubling article from The Seattle Times. According to health reporter Carol Ostrom:
Suppose you happen to be in a serious car wreck. Or maybe you get shot or suffer cardiac arrest. If you live in King County, it might also mean that in that life-or-death moment, you will become part of an experiment — without your consent.
Turns out, the UW studies--part of the Resuscitation Outcomes Consortium (ROC)--are making use of a conveniently placed loophole in federal law to carry out research on emergency victims without having to go through the normal process of consent. EMTs in ambulances, at the prompting of computers, will test new treatments on trauma and heart attack patients. One tests the effectiveness of a stronger version of the saline solution given to trauma victims with crashing blood pressure. The other tests whether it's better to be given CPR for three minutes before applying defibrillators to heart attack victims. Additionally, they will be testing something called (according the Resuscitation Outcomes Consortium's website) an "impedance threshold device (ITD), which enhances venous return and cardiac output by increasing the degree of negative intrathoracic pressure during decompression," not that we entirely understand what that means.
Neither issue here is particularly galling in and of itself--the research may in fact lead to better treatment for trauma and cardiac arrest victims. What's so troubling is that a patient in an emergency situation will--without their knowledge or consent--be given treatment without advice or information from a medical professional of a level higher than an EMT, if at all. Normally, clinical research subjects are supposed to grant informed consent, which means that they have to both demonstrate they understand the procedure and its risks and agree to undergo them. According to the website of the American Medical Association, in a normal clinical environment (not a test), the doctor (specifically stating the doctor, "not a delegated representative"), needs to inform the patient of his or her diagnosis, the nature and purpose of the treatment, its risks and benefits, and those of both refusing the treatment or of any potential alternatives. So how has it come to be that an EMT is now performing treatments at computerized direction with no concern over consent, to the effect that defibrillation to restart a stopped heart could be delayed for up to three excruciatingly long minutes?
Precisely, it's located in the Code of Federal Regulations, Title 21, Chapter 1, Subchapter A, Section 50.24 (who wouldn't have trouble finding that?). This section of the code, on "Exception from informed consent requirements for emergency research," stipulates that standard informed consent practices may be waived if the subjects are in a life threatening situation, or are unconscious or can't give consent, their representatives can't be found, or if the researchers couldn't figure out who to seek consent from before starting.
In that last case, the researchers are supposed to seek "community consultation and public disclosure" about what they're going to be doing, so that people are more or less aware that should they get in a terrible car wreck, in addition to being charged exorbitant fees for ambulance service, they may have the added benefit of being a lab rat. According to Carol Ostrom, the UW "contacted media outlets, placed information in newsletters and on the online classified-ad site Craigslist, created Web sites and bought bus ads."
There is, theoretically, a way to protect yourself from being a lab rat--er, test subject: According to Ostrom's article, you can simply contact the ROC (800-607-2926 for the cardiac arrest study, or 800-607-1879 for the trauma study--thanks due to Ms. Ostrom) to get a little bracelet for free that says "No Research Study." It's the equivalent of British patients whose National Health Service has gotten so bad they have to write in magic market which leg not to amputate. Thing is, Seattlest's friend requested one Monday, and she's still to hear a peep. That said, although we didn't document the UW's page on opting out, according to sources they did take the time to update it since Ostrom's article appeared. A new section has been added to discourage you from even bothering. A special note for the ladies--you better like your medic-alert bracelet, because "You will have to wear this bracelet during the time the study is being conducted – through 2009." And anyway: "Even if you wear this bracelet there is no guarantee that under emergency circumstances the bracelet will be read by those providing care for you. You might still get the enrolled in the study." But don't worry, if they do accidentally treat you like a bunny rabbit at a make-up factory, afterwards, they'll just delete the data they collected on you from the study, making your unwilling sacrifice utterly useless.
There's nothing you can do, kids, it's Chinatown.


