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Brain Injury Study Approved Without Patient Consent

Traumatic brain injury patients could be enrolled in a medical study, possibly without their consent, starting as soon as next month at two Boston hospital emergency departments. 

The study - to be conducted at Massachusetts General Hospital and Boston Medical Center - will test whether administering the hormone progesterone in the hours immediately after an injury could limit brain damage, as early studies have shown it may slow the process of cells continuing to die following the initial trauma.

This is the first study approved at Boston hospitals using an exemption to the federal requirement to get approval from the patient or a surrogate before administering an experimental drug. The researchers will obtain consent if the patient can communicate or if family can be located within the hour following the injury, but will also administer the drug and give the option of pulling out of the trial later if that is not possible. Read the full details here:

Hospitals OK study of brain injury treatment without consent

Investigational studies may help patients in the future, but they also run the risk of damaging those who initially try them. The concern with this study is a patient could be enrolled without a choice and end up being worse off for it.

If you or a family member believe you have a medical malpractice case, including lack of informed consent, contact Crandall & Pera Law today for a free case evaluation. Crandall & Pera Law is available to help answer your questions and guide you in determining your next steps.

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