Two Massachusetts hospitals may co-opt TBI patients into a study without their permission

Traumatic brain injury (TBI) patients in Massachusetts may end up participating in a study without giving their permission.

While the question of informed consent is a huge one when being admitted to hospital and having procedures, tests and diagnostics run, being enrolled in a medical study without consent may cross a legal line. If negligence is involved, being co-opted into a medical study could spell serious issues for the hospitals.

Boston Medical Center and the Massachusetts General Hospital have launched tests to see if giving traumatic brain injury patients progesterone as soon as possible after a head injury limits brain damage. Evidently, there are current studies that show the hormone may slow the secondary cascade of injuries that come on the heels of the initial trauma. The trial was approved by review boards at both facilities.

According to federal law, researchers in this study must obtain an okay for the patient or patient surrogate prior to giving an experimental drug. This particular trial is one of the first that relies on a 1996 exemption to study emergency treatments. Legally speaking, if something went wrong during the course of the study involving a patient that had not provided an informed consent, the exemption could face successful challenges in a lawsuit.

This study is not solely taking place in Boston. There are over 40 other hospitals in the nation also focusing on whether or not progesterone helps limit brain trauma if administered early. Researchers attempt to get consent from a victim if they are able to communicate their wishes or if their family consents. The reality is that TBI patients often come in needing immediate treatment and medical personnel cannot wait for the family to be found and may not be able to talk to the victim. This means that in an emergency, the drug would be given and an option offered to opt out of the trial later.

The fact that the researchers have provided a phone line for those wishing to opt out of the study is encouraging and a step in the right direction to address anyone’s concerns about being given an experimental drug. Again, the reality of an emergency situation may mean the drug is given anyway.

The main question in situations like this becomes whether or not the patient, or their family, would object to the possibility of a life enhancing treatment, even if it were experimental. Many may feel that any chance at all is preferable to going without treatment and facing the life altering consequences of TBI. This is not to say that treated TBI may not still change someone’s lifestyle, but the progesterone may reduce the severity of the changes.

If you find yourself in a situation like this and have objections to being given drugs without your consent, it is wise to seek the counsel of an experienced Austin personal injury lawyer. This is groundbreaking medicine that may save lives, but there are still those who would prefer not to be test subjects without knowing how a drug or procedure may affect them.

Posted on: September 18, 2013 | Tagged

Perlmutter & Schuelke, PLLC maintains offices in Austin, Texas. However, our attorneys and lawyers represent clients throughout the state of Texas, including Dallas, Houston, San Antonio, Forth Worth, El Paso, New Braunfels, San Marcos, Kyle, Buda, Round Rock, Georgetown, Lockhart, Bastrop, Elgin, Manor, Brenham, Cedar Park, Burnet, Marble Falls, Temple and Killeen. By Brooks Schuelke


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