Tagged: informed consent

Uninformed Consent: Die for the Advancement of Medicine?


University of Pittsburgh Medical Center has been conducting a study in treating severely-wounded patients who are brought in for critical care. The study is called “EPRCAT: Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma”. Part of the study involves bringing the patient’s body temperature down to 50F by draining the blood of the patient, whose heart stopped beating, and replacing it with cold salt-water to cause artificial blood loss. Once the patient’s body is cold enough, researchers expect that they can “buy time”,  gaining surgeons an extra two hours to treat the patient for their wounds. Once the surgery is complete, surgeons will return blood to the patient, causing the body to warm up gradually and eventually catch up with oxygen.

This “dramatic approach”, as the research team call it, began in or around 2011 and recently the NY Times published an updated story.

Both articles specifically mentions that the study is funded by the U.S. Department of Defense.

Unsurprisingly, this study has been unable to get participants upon consent. Any medical studies that involve human bodies need to obtain informed consent from study subjects (patients). When patients are under a very specific condition – cardiac arrest – how will they sign consent forms? Will the surgical team force-sign a consent form by holding pen for the critically-injured, since that person might die anyway? Undaunted, these researchers have simply begun enlisting patients who come to the hospital with serious trauma injuries, without their explicit consent, to be test subjects.

NY Times reports:

“Black males are disproportionately victims of homicide, especially gun violence, and most of the patients likely to fit the study criteria in Pittsburgh are African-American males, according to officials at the medical center.”

This is no coincidence. Since the earliest days of slavery, black Americans have been victimized by nonconsensual medical testing. The notorious Tuskegee Syphilis Experiment  is perhaps the most famous example, and only a single episode in a long horrific history recently captured by historian Harriet Washington in the book Medical Apartheid. When the researchers in Pittsburgh selected a disproportionately black demographic for their testing, they did so with the confidence that comes from centuries of unaccountable medical experimentation on black Americans.

In the early stage of the research, the team began a campaign required by the Food and Drug Administration to educate area residents about the study. One of this is a Youtube video which has only been viewed 49,239 times at the time of writing. The video explains the course of the study using dummies and prompts people to spend time to contact the reseach team in order to opt out from the study: “Community members who do not wish to participate in these research studies can obtain a bracelet to opt out by going to acutecareresearch.org or contacting Tina Vita at 412-647-9652.” This perverts the notion of “consent” even more than a forced signing of consent forms, as ignorance of the program itself can be construed as consent. Even those aware of the program must navigate the bureaucratic process of obtaining a bracelet, to be worn at all times, presumably, to simply avoid becoming a test subject.

The Florence Johnston Collective is horrified by the nature of the study as well as the method of implementing the uninformed consent from the community members, and, perhaps especially, its targeting a particular ethnic group.

We are also looking further into seemingly cozy relations between hospitals (especially university-affiliated hospitals) and the Department of Defense, which we encourage others to investigate as well. We expect to find more of the same compromise of medical ethics, coupled with the increasingly obvious signs of a US state no longer concerned with even the appearance of human rights and the rule of law.

In the meantime we urge all health care officials to boycott this program, which violates not only good standards of professional ethics and human compassion, but also the Hippocratic Oath itself. Medical professionals who participate in this study willfully should not expect history to regard them as favorably as the current racist state does. And their work should be made as difficult as possible.