Controversy Erupts Over Proposed Boston Traumatic Brain Injury Study without Patients' Consent

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Book & GavelMost people are not medical researchers or scientists, and therefore most people are not aware of all of the rules, norms and regulations that are part of the field of medical studies.  However, most people would generally be able to correctly assume that people who do take part in these studies have given researchers their permission, and when these studies involve children the parents of these children also provide permission.  That has not necessarily been the case since 1996, when the Food and Drug Administration created an exception that allowed for participation in medical studies in emergency situations without subject approval.

For the first time since that rule was changed, researchers in Boston are looking to make use of that exception in order to take part in an ongoing national study regarding a treatment strategy for people who suffer traumatic brain injuries.  Specifically, researchers from the Boston Medical Center and from the Massachusetts General Hospital are hoping to begin giving patients who report to their facilities with traumatic brain injuries a treatment that involves using the hormone known as progesterone.  It has shown some promise in previous research efforts in terms of limiting the damage that is done to brain tissue in the hours immediately after the trauma is inflicted.

As many would expect, this desire has been met with outrage from many in the medical research field.  Although a strong argument could be made that the exception would apply here considering the time-sensitive nature of the injury and the fact that many people who suffer traumatic brain injuries are unconscious and report without family members, ethicists believe that there is simply never a good reason to include someone in a study without permission.  There is no way to predict what will happen or whether the plans relating to this study will move forward.

Progesterone has been shown in previous studies to reduce the mortality rate of people who suffer traumatic brain injuries and it has shown an ability to limit the damage that tends to be inflicted on brain tissue in the hours that immediately follow the injury.  As such, those in support of this approach are arguing that using progesterone is safe and that the risks involved with using it are such that it should be allowed in these limited situations.

As of now, 40 different hospitals around the country are participating, and the hope is that more than 1,100 patients will be included in it before the study runs its course at the end of 2014.  The study is large because the medical research community believes that it can prove something definitive if the earlier findings regarding the use of progesterone prove to be accurate.

This is obviously a very complicated question and one that will have to be worked out by those involved.  There is no easy answer for this issue, much like there is no easy course of recovery for people who have suffered in this manner.  Serving clients as traumatic brain injury lawyers has shown us just how badly people can struggle when they attempt to come back from head trauma.  If you or someone you love has been harmed in this way, contact the Scarlett Law Group today to schedule a free initial consultation.