Have you ever seen the movie, “While You Were Sleeping?” In the movie, a man befalls an accident and lies in a coma for a time. While he is asleep in this coma, a young woman who admired him by afar befriended his family, telling them that she was his fiance. When he finally awakes, he doesn’t remember that he was not affinanced to this young woman, who has of course, fallen in love with his brother.
Likewise, in real life, there is an important update that everyone should be aware of in a clinical trial involving medication for the treatment of seizures. The study is to try to find out whether or not giving anti-seizure medications work better or more quickly when injected directly into the vein or when given by intra-muscular (or into the muscle) injection.
In most studies, individuals are informed prior to consenting to participate in a study, any laboratory testing and medications that will be administered during the study.
The Food and Drug Administration (FDA) has a special rule that has been put in place for situations when people are considered too sick or incapacitated to agree or decline to participate in research. This situation, called the “Exception From Informed Consent, ” is allowed when there are few or no proven treatments for a life threatening medical situation and the person is unconscious or unable to give consent. Due to this rule, called EFIC, everyone that has or may have a prolonged seizure will be automatically enrolled in the study, UNLESS they “opt out” prior to the study beginning. Anyone who does not wish to participate in the study must call 1-866-929-6388 to mark their intention not to participate and are assigned a braclet to wear that will identify that decision.
******************************************************************************************************************************
Paul E. Deloughery is the founding partner at the Scottsdale law firm of Deloughery & Ruotolo, P.C. You may contact Paul at 602-443-4888 or by email at paul@delougherylaw.com. For more information, go to www.delougherylaw.com.
Disclaimer: The information contained in this article is made available for general informational purposes only, and is not intended to constitute specific legal advice or to be a substitute for advice from qualified counsel. For that reason, you should not act or refrain from acting based on any information in this article without first obtaining advice from professional counsel qualified in the applicable subject matter and jurisdictions.
23Kazoos
Jennifer Wong
