An Unresolved Dilemma: Community Consent for Emergency Research

Episode: 
105

You’ve heard me say that bioethics presents us with dilemmas. Well, here’s one I’ve had a hard time sorting out. It involves the conflict between informed consent and medical research in the emergency room.

When a gunshot survivor or car accident victim comes into the ER severely bleeding, doctors usually give patients a blood transfusion. The blood transfusion is one of several mixtures of different types of cells, but no one has studied which mixture works the best.

This is the question researchers at 12 trauma centers around the country want to address through a new research study.[1]  ER patients would be randomly assigned to receive one of three possible mixtures of blood cells. Each of these is a standard form of treatment at some hospitals, and each is designed to benefit the patient. The problem is that trauma victims are not able to give voluntary, informed consent while they are bleeding to death! 

Because of painful lessons learned through history, here in the U.S., during Nazi Germany and elsewhere, many, if not most, ethicists strongly believe in the importance of ensuring that every person who participates in a clinical trial gives their voluntary, informed consent. We go to great lengths to be sure that people know as much as possible about the study they are participating in and that they consent freely, without coercion. No one should be exploited in the name of medical research.

To address this problem, the FDA developed rules in the 1990s for community consent in situations like this where traditional consent was just not possible. In the place of individual consent, doctors must discuss their plans with community representatives and with the community as a whole before starting their research.[2] Community members could then choose ahead of time not to participate.

Of course, you can’t get 100% participation, and it’s unlikely people will bother to “opt out.” But, some studies show significant community support for this kind of Exception From Informed Consent (EFIC).[3]

On the other hand, some bioethicists are concerned that community consent simply does not adequately preserve the principle of voluntary participation and informed consent. After all, how can we be sure that every patient who comes into the ER has been a part of community consent? There’s no time to check. To add another wrinkle: what if one of the treatments included an experimental drug? We need to think about whether this is a case of the good goal of life-saving medical research justifying the unethical means, violation of informed consent.

What do you think? The simple way out would be for me to tell you what to think. Dilemmas such as these show how important it is that Christians—who value human dignity and medical research—learn how to think and talk about these issues. At the very least, it’s a conversation starter.



[1] Andrea K. Walker, “Maryland Shock Trauma seeks community consent on blood plasma study,” The Baltimore Sun. October 13, 2012. http://articles.baltimoresun.com/2012-10-13/health/bs-hs-shock-trauma-study-20121013_1_trauma-centers-patient-consent-blood-products

[2] “Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research,” Federal Register 61, no. 192 (October 2, 1996): 51497-51531. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm118995.htm

[3]  Scott E. Kasner and others, “Community Views on Neurologic Emergency Treatment Trials,” Annals of Emergency Medicine 57, no. 4 (April): 346–354.   http://www.annemergmed.com/article/S0196-0644%2810%2901239-4/. Cf.

Biros, Michelle H., Corey Sargent, and Kathleen Miller, “Community attitudes towards emergency research and exception from informed consent,” Resuscitation, Volume 80, no. 12 (December 2009): 1382–1387. http://dx.doi.org/10.1016/j.resuscitation.2009.08.019.

 

 

 

 

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