Boston Hospitals Okay TBI Brain Injury Study Without Patient Consent
As soon as next month, patients brought to emergency departments at Massachusetts General Hospital or Boston Medical Center to be treated for traumatic brain injuries could be enrolled in a medical study, possibly without consent if they or family are not able to give it.
The somewhat controversial trial aims to test whether administering progesterone in the hours immediately after an injury could stall or prevent secondary damage. They are hoping to find a proven treatment option for the “secondary cascade” of injuries that follow the initial trauma as cells continue to die and swelling possibly occurs leading to other injuries.
Federal law requires researchers to gain approval from patients or a surrogate such as a family member before enrolling patients in experimental treatments, but an exemption established in 1996 allows for the study of emergency treatments. This trial, which Chelsea Conaboy reports have now approved by both hospitals involved, will be the first approved and enacted by Boston hospitals since the exemption.
The Boston hospitals are joining 40 other hospitals studying the hormone in brain injury in different situations. If the patient arrives able to communicate or with family the researchers will ask for consent, but if the family cannot be located within an hour of the trauma and the patient is unconscious or unable to speak, the medical staff will administer the drug, with the option to pull out of the trial always available.
The team will also be required to undergo additional technical training and meet with national network leaders before enrolling patients. Patients who would like to preemptively opt out of the study can call a hotline number so that they will not be included if they suffer a brain injury.