By On June 13th, 2013

Boston Researchers Seek Drug Trial Without Consent

Progesterone Chemical MakeupA group of Boston doctors is proposing to join a study that would offer emergency care and treatment to brain injury patients without first obtaining the patient’s consent. They argue that often brain injury patients arrive at hospitals unconscious or without family members who can speak on their behalf, so these doctors need to opportunity to work without the consent normally required.

Federal law and the generally accepted, sometimes unspoken ethics of medical research require that patients or their surrogates be informed of any risks of participating in a study and have the chance to refuse their placement into the study. However, a loop hole has existed since 1996 that allows for an exemption in certain cases involving emergency treatment. This would be the first study to use the exemption since it was established by the Food and Drug Administration over fifteen years ago.

The proposed study is highly controversial, and many argue it is entirely unethical, such as George Anna, a Boston University bioethicist who spoke with The Boston Globe. He said, “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.”

The proposed study hopes to observe whether giving the hormone progesterone to patients in the hours immediately following a brain damage could prevent further neurologic damage from swelling, fluid build-up, or metabolic changes in the hours after trauma. The process of which these potentially damaging effects happen is often referred to as a “secondary cascade” of brain injury, which has proved difficult to slow.

Progesterone has been shown in previous studies to be safe in humans with TBI and could possibly lower the mortality rate after one month. The hormone, involved in women’s menstrual cycles, was first believed to be beneficial for TBI after Dr. Donald Stein of Emory University noticed decades ago that female rats fared significantly better after brain injury than their male counterparts.

All previous studies worked without the exception however, which caused the average time to administer progesterone after injury to be around four and a half hours. Scientists believe the “secondary cascade” can begin immediately after injury however.

The proposed research team has issued surveys, hosted a table at Boston University’s wellness fair, held focus groups, and made presentations to community groups, hoping to build community support for the trial and raise awareness. They have also established they will seek family members in the immediate time after a patient is brought to emergency care before continuing without consent. Still, the ethical gray area has many uncomfortable, and it is unclear whether it will be approved.

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