Up at 5AM: The 5AM Solutions Blog

Suspense! Consent Management in an Emergency

Posted on Wed, Jun 11, 2014 @ 06:18 PM

Imagine the worst: you’ve been shot, and your chances of survival are dismally slim. It goes without saying that when rushed to the ER, you’re unconscious. 

A Clinical Study: The Best Case Scenario

If there were an upside to this tragedy, it might be that the ER to which you’ve been rushed is the University of Pittsburgh Medical Center Presbyterian Hospital. There, you could be part of a groundbreaking study to save serious trauma victims’ lives.

 A team led by Dr. Samuel Tisherman is conducting a study at the hospital in which serious trauma victims — those suffering gunshot and stab wounds— are placed in a kind of suspended animation.  


Doctors drain all of the blood from the patient’s body, and replace it with a saline solution cold enough to quickly lower the body temperature to 500F (100C). At that temperature, most cellular activity stops, and the patient is in a narrow space that is not exactly living, but not dead either. This condition gives doctors what they need most when trying to save critically a critically injured patient: time.

The doctors on the UPMC team don’t like hearing the process described as “suspended animation” because it makes the intervention sound like science fiction. The procedure is actually called emergency preservation and resuscitation (EPR) and it is slated to be tested on ten gunshot and stabbing victims. The experiment’s success will be measured against ten similarly injured control subjects receiving traditional emergency interventions. 

Exciting? Yes! Especially because there is compelling evidence that such a procedure could revolutionize the way that doctors intervene in the most critical emergencies. 

The technique was first demonstrated in pigs in 2000 by [University of Arizona surgeon Peter] Rhee and his colleagues. The animals were sedated and a massive haemorrhage induced, to mimic the effect of multiple gunshot wounds. Their blood was drained and replaced by either a cold potassium or saline solution, rapidly cooling the body to around 10 °C. After the injuries were treated, the animals were gradually warmed up as the solution was replaced with blood.

Better Consent Management

Because of the severity of the patients’ injuries in cases like the Pittsburgh study, patients and their families will be unable to consent. This is perfectly above board. When patients’ chances for survival are extremely low using established treatments, FDA rules permit exceptions to informed consent if an experimental procedure shows evidence that its results are significantly better than those of established treatments.

 In the Pittsburgh study — and similar ones — researchers post community notices in newspapers and on the internet to let local populations know about their studies and the risks involved. In Pittsburgh, people were given the opportunity to opt out online. No one did.

As more and more health data becomes accessible to more and more people, consent management will become more of a moving target. Researchers, clinicians, and innovators will have to monitor the onslaught of paradigm-shifting technologies change the research landscape, including consent management.

 Last week, for example, Apple released iOS 8. The newest release of the operating system includes an app called HealthKit. Here’s how Apple describes it: 

HealthKit allows apps that provide health and fitness services to share their data with the new Health app and with each other. A user’s health information is stored in a centralized and secure location and the user decides which data should be shared with your app.

Opportunities for health care innovation abound! One can easily imagine that besides having your doctor’s name and address in your iPhone contacts, you could also opt-in or out of emergency studies like the one going on at UPMC. In fact, 5AM published a whitepaper entitled Clinical Trials: Focus vs. Driving Efficiencies Blindly.

The paper describes how innovative health IT systems can support consent management. The paper was published in 2012, however the constant flood of increasingly consumer-accessible health data makes it just as relevant today.

Hear about the UPMC study from Dr. Tisherman below.



Tags: EHR, electronic health records, health IT, EMR, informed consent, consent, clinical trials


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