Drug Trial Proposal On Non Consenting Patients

Researchers propose drug–trial on non–consenting patients

http://www.bioedge.org/index.php/bioethics/bioethics_article/10563

A controversial drug test on non–consenting patients has been proposed by doctors in Massachusetts. The trial, which will test the effectiveness of the drug progesterone, would involve patients who have sustained a brain injury a few hours before treatment. Many patients arrive at hospital unconscious and doctors argue that they need to perform the test without their consent. 

The study, recently submitted to the Food and Drug Administration for approval, will examine the efficacy of the drug in preventing a “secondary cascade” of brain injury resulting from swelling, fluid build–up and metabolic changes.
“We have a devastating disease that causes tremendous lifelong disability for people around the country and around the world, with no proven treatment,” said Dr Joshua Goldstein, an investigator and director of the Center for Neurologic Emergencies at Massachusetts General. “We’re hoping that the time has come to find a treatment.”

But some bioethicists believe that informed consent is almost always more important than research. George Annas, a Boston University bioethicist who is not involved in the brain trauma proposal, argued that “you need something that’s as powerful as consent”. “People don’t expect to be researched on when they go to an emergency department, and they don’t consent to research just by being in an accident”, he said.

Federal law and the generally accepted ethics of medical research require that patients or their surrogates be told about any risks of participating in a study and have the chance to refuse enrolment. But in 1996 the FDA created rules allowing exemption in some cases involving emergency care. With 40 hospitals already participating, the trial has enrolled more than 760 people. 

This is easily the most controversial story in the news this week. This research may be vital and may benefit countless numbers of people but at what cost? This process gives no respect to patient autonomy at all, something which I believe to be one of the most important factors in caring for a patient. I believe a new approach is needed. Patient autonomy should always be respected irrespective of the circumstances. There are of course grey areas in which sometimes patient autonomy is circumnavigated to good effect. However, the principle must stand. If this is allowed then other not so well intentioned researchers would find it a lot easier to emulate this study for more drastic actions. Aside from the above implications, what would happen if this drug doesn’t work or even worse does significant damage to the patient they haven’t even asked permission from? The fallout from such an action would be catastrophic, the doctors in question would no doubt be struck from the medical register and patients would lose their trust in the people in whose hands they put their lives.

This trial will not work as patient autonomy must be respected and the doctors themselves are putting themselves in a very dangerous position if there are unforeseen complications and the drug goes wrong. If the treatment of this disease is paramount then a mandatory register should be set up asking patients to opt out if they do not wish to have this drug tested on them. In this way patient autonomy is respected – the doctors are protected as they have had the patents prior consent.

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