Under federal law, scientists need to get a patient’s approval before they administer an experimental drug to him or her. But that’s not what will be happening at two major Boston hospitals
According to a very interesting blog in the Boston Globe, Massachusetts General Hospital and Boston Medical Center will be participating in a trial involving a drug for brain injury, and patients who come to them for emergency care may get that drug without signing off on it.
http://www.boston.com/lifestyle/health/blogs/white-coat-notes/2013/07/10/hospitals-study-brain-injury-treatment-without-consent/6YRspbwJk7Aj2etExIooDO/blog.html
The trial is trying to determine if giving a patient progesterone in the hours right after a traumatic brain injury (TBI) can curtail some of the damage, the Globe said. Preliminary studies have found that the hormone slows down the ongoing death of brain cells after a TBI.
So under an exception to the federal law regarding permission, the two Boston hospitals will be operating “under an exemption created in 1996 to study emergency treatments,” according to the Globe.
Mass. General and Boston Medical Center area part of a group of 40 hospitals nationally that are studying progesterone and brain injury.
The newspaper reported that researchers will seek consent if the patient is conscious or family can be reached within an hour of the injury, the Globe reported. If that can’t be done, doctors will give the patient the drug, and the patient can drop out of the trial later.
A Mass. General official said that the hospital has been doing outreach and education about the drug trial. If a person wants to opt out of the study should they they sustain a TBI, they can call a phone number right now that the Globe provided to do so.
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