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A group of Boston doctors is proposing to study an emergency treatment for brain-injured patients without obtaining the trauma victims’ consent, arguing that they often arrive at the hospital unconscious or without family members who can speak on their behalf.
Federal law and the 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 enrollment.
But the law allows for an exemption in certain cases involving emergency care.
This would be the first such study conducted at Boston hospitals since the US Food and Drug Administration created the rules allowing for it in 1996.
Such research is controversial and some ethicists argue that it is almost never appropriate.