Conducting research without the consent of the research subject

A new study poses one of the most vexing ethical questions concerning research with human beings: When is it acceptable to conduct research without the consent of the research subject?

In emergency situations, patients often arrive at the hospital unconscious or with severely impaired decision-making capacity. Progress in medical practice depends on results from carefully designed research; yet in these emergency cases such patients are unable to fulfill one of the basic ethical requirements for research—the ability to consent.

This is precisely the situation in a clinical trial involving severely injured trauma patients at the University of Pittsburgh Medical Center and other collaborating institutions. In a pioneering study — the first in humans — surgeons will drain the subject’s blood, replacing it with freezing salt water, rendering the individual clinically dead. The technique is known as “emergency preservation and resuscitation,” or EPR. It provides needed time for the surgeons to administer lifesaving procedures.

It is well known that people can survive for hours with little or no oxygen if their bodies are cooled to abnormally low temperatures. But this procedure — replacing a person’s blood with freezing water — is a novel approach. So far, it’s been tried only on dogs and pigs. Following the surgery, the subject’s own blood is returned to the body, which will be warmed gradually.

Exception from informed consent requirements

You might wonder, then, how researchers resolve the conflict between the need for consent and the desire to advance medical knowledge.

Federal regulations allow researchers to conduct studies in emergencies without the consent of the subject, but the conditions are stringent. The following requirements (among others) must be met:

  • the human subjects are in a life-threatening situation and available treatments are unproven or unsatisfactory
  • participation in the research holds out the prospect of direct benefit to the subjects
  • the research could not practicably be carried out without the waiver
  • obtaining informed consent is not feasible because:
    • the subjects will not be able to give their informed consent as a result of their medical condition
    • the intervention involved in the research must be administered before consent from the subjects’ legally authorized representatives is feasible
    • there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the research

video posted by the hospital explains that patients in the study will include victims of trauma such as gun violence or stabbing who are in cardiac arrest. Victims of blunt trauma, such as car accident victims, won’t be eligible. In addition, the researchers will exclude pregnant women, children and patients over the age of 65.

Community notification and consultation

An additional requirement involves advance consultation with representatives of the communities in which the research will be conducted and from which the subjects will be drawn. This requirement has often puzzled researchers seeking a waiver of informed consent and institutional review boards that prospectively review research proposals and are responsible for granting such waivers.

Here is what the University of Pittsburgh researchers did.

The hospital organized two open meetings on the university campus. In Pittsburgh, one group highly likely to be affected by gun violence and stabbing traumas is African American males, who, according to published research, make up 83% of male homicide victims in that city. For that reason, researchers placed announcements of the study on buses and in newspapers likely to be read by African American males.

A page describing the study was created, and a phone survey was conducted in neighborhoods from which subjects would most likely be drawn. But a look at the page reveals that it is not geared to the population most at risk and is unlikely to provide the kind of information that fully complies with the community notification requirement.

As an added protection for people who would not want to be unwitting research subjects, researchers also distributed “no EPR” bracelets to individuals who requested them. But even with the concerted effort to inform and obtain feedback from the community, according to the New York Times three African American men who work near the hospital said they had never heard of the study, though they said they did not object to the trial.

Still, the need for proper consultation remains. One possibility would be to hold the town hall meetings in a community center in the African-American neighborhood instead of on the university campus.

What would you do to expand awareness and consultation?

Ruth Macklin is a professor, department of epidemiology and population health, Albert Einstein College of Medicine, Bronx, NY. She blogs at The Doctor’s Tablet.

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