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09/30/2016

BioethicsTV: Community Research Consent and Competing for an Infant Heart

by Craig Klugman, Ph.D.

In the fall premiere of Code Black, military trauma surgeons are visiting the hospital on an annual pilgrimage to share what they have learned treating battlefield injuries. On a beach, a patient has been bitten by a shark and is bleeding internally. One of the new gadgets the military has brought is medical foam, which is similar to foam insulation in a house, though in a person the foam plugs the holes in a body. A tube is placed inside the body and self-inflating foam is released until it oozes out of the multiple bite holes. The result is pressure on all tears and sites of bleeding (the vessels and organs are essentially plugged) and the internal structures are protected from movement. At least on TV, the foam can be peeled away from the organs with no damage. The only problem, the viewer is told, is that the foam has never been used in a human being before. The patient is essentially an unknowing participant in an experimental treatment.

It turns out that this foam is real and that it does significantly increase chances of survival from internal bleeding, at least in animals. The ethical issue raised in this episode is that of consent for experimental treatments in pre-hospital emergency medicine. One of the major challenges of research in emergency medicine is using new techniques on patients who are incapacitated and cannot give consent. That certainly is the case here. First, such a protocol would need to have undergone IRB review at the institution. No mention is made of this process having occurred. Even if this was not a trial but simply one-time use of an investigational device, approval would have been needed from the IRB and the FDA. Second, a trial of this sort would require a waiver of informed consent by individual subjects since an incapacitated person cannot consent. According to the Common Rule (Code of Federal Regulations Title 21, Volume One, Part 50.24,), a waiver must be approved by an IRB and must meet certain criteria:

  1. Subjects must be in a life-threatening situation where other treatments aren’t very satisfactory
  2. Not feasible to obtain consent
  3. A reasonable potential of direct benefit
  4. The research could not be carried out without the waiver
  5. There must be a period of time when researchers try to obtain consent
  6. Public disclosure in the community that the research is happening
  7. Independent data monitoring committee must provide oversight

Although 1-3 were met in this episode, the others clearly were not. As we learned from the poly-heme trials, community disclosure can be carried out through town hall meetings, notices in newspapers and media, and meetings with community leaders. Given that the scenario in Code Black was not a trial but a one-time use, one could argue that it is represents off-label use where physicians can try something for an indication for which it has not been approved.

Perhaps the foam was under a HDE (humanitarian device exemption) approval process with the FDA. An HDE does not require results of a clinical investigation, but the use of the device must be shown to outweigh the risk of injury or illness. Actual use in a hospital, however, does require IRB approval. While an FDA-HDE designation does not require informed consent, the IRB may require it.


On Chicago Med (season 2, episode 2), Dr. Rhodes is caring for an infant in heart failure who is number 4 on the transplant list. Dr. Manning is treating another infant who is getting sicker by the hour. After being intubated, the survival of Manning’s patient is in doubt. Rhodes approaches Manning and asks if she would talk to the family about HLA testing and organ donation. She states that Rhodes is putting her in an ethically precarious position because she does not yet know what the problem with her patient is and the family is not ready to think about losing their child. But, Manning does talk to them and they agree to the HLA testing. The parents of the first baby keep looking over at the second one, waiting (perhaps hoping) for a diagnosis of brain death and a heart that does match their child. As Manning states, if her patient recovers than Rhodes’ dies and for his to survive, hers must die.

Manning follows a hunch and discovers that her patient is suffering from botulism. She believes the treatment will be successful and the baby will be fine with no deficits. That happy ending means that Rhodes’s patient will die.

Rhodes being an advocate for his patient is noble. He even goes out on a limb trying to convince the physicians of the 3 patients ahead of his on the list to let his patient get the next heart. He does cross a line in preying on another doctor’s patient for the heart. This conceit, however, is a fairly common storyline in medical dramas—a dying patient needs an organ and another patient dies, providing that organ. Of course the twist here is that the sick patient recovers. If Manning’s patient had died, then the only way for Rhodes’ patient to receive this heart would be for Manning’s family to direct donate the organ. Otherwise, the heart goes to the first patient on the list with an HLA match. Also, in reality, the conversation on donation is unlikely to be held before brain death is diagnosed and is usually conducted by someone from the local organ transplant organization, not by the attending physician. To do otherwise would be as the father of Manning’s patient says to her, “You’ve already written her off and are carving up our baby.” This is one conflict of interest that threatens trust with a patient’s family and questions whether loyalty is to that patient or to a colleague and his desire to help his patient.

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