My E Mail to the Pediatric Seizure Study

Photos

My E Mail to the Pediatric Seizure Study

see larger image

uploaded by Karen Hatter

Thank you for your responses to my questions.
 
After reading your responses, additional questions have occurred to me to ask but, I will confine myself to responding to your request for my thoughts regarding the Pediatric Seizure Study and my questions concerning right of refusal.
 
I will begin by stating that regardless of Food and Drug Administration (FDA) regulations allowing the enrollment of participants in a study with special waivers for informed consent, created in 1996, which has led to the Department of Health and Human Services (DHHS), various other government agencies and the American Medical Association (AMA), drafting their own guidelines based on the FDA guidelines and all of the related ethics committees that held discussions on this subject, I am opposed to the possibility of my child and other children being used in this manner without the approval of, in the case of my child, myself and my husband and in the case of other children, their parents, loved ones or representatives.
 
I have specific concerns with this and all studies that have been and may be conducted by the Pediatric Emergency Care Applied Research Network, the first ever federally funded pediatric emergency research network. I see a possible dangerous situation existing with government agencies enacting rules, then in turn, as funding agencies, funding research that has been approved by some of the same or related agencies, with money being funneled from within this alliance to a network of affiliated hospitals created by these government agencies, virtually increasing or assuring any study proposal submitted will be conducted without informed consent.        
 
I disagree with the perception that as long as community outreach of some sort is conducted that, by extension, any possible candidates to be drafted into studies without their consent, have been duly informed with this outreach serving as informed consent.
 
Because I have been made aware that a situation of which I am vehemently opposed will occur in my community does not allow those engaged in that activity to respond as if I have somehow agreed to their actions based on the fact I have not complied with the limited options given to those like myself that do not want the activity to occur.
 
In the case of the Pediatric Seizure Study, it may be that the two drugs being tested may be used in the normal treatment of individuals for status epilepticus and although lorazepam or Ativan, has been prescribed 'off label' by physicians, as everything I have read says, it has not been officially approved for use in children.
 
I strongly believe that experimenting on children in this manner, when they are most vulnerable, and I know this word may be viewed harshly, but, it is an experiment if the reason for comparison of the two drugs is to gather data to determine which would be most effective for use in this manner, to be a violation of the child's rights and that of the parents or guardians.
 
In a double blind study, by eliminating the doctor and staff's possible input in treating the patient, you deprive them of the on the scene ability to use their experience and knowledge to make an informed decision. The computer cannot apply experience when it makes selections.
 
I feel that this and all studies that have been conducted and are currently being done, that plan to enroll and have enrolled incapacitated patients against their will or without input from their family or representatives acting on their behalf is unacceptable and criminal.
 
I believe that the main reason these studies are being pursued in this manner is that the medical community is aware that most individuals, as patients, or as parents, loved ones or representatives acting on behalf of patients would not agree to being experimented upon or having their loved ones experimented upon while they were in this most vulnerable state.
 
All of the reasons given for allowing the dismissal of acquiring informed consent from parents to enroll children into the Pediatric Seizure Study are unacceptable to me as a parent and as an individual who believes that everyone should have a choice whether to be experimented upon and not be enrolled without their consent.
 
I hope my thoughts will be considered concerns that should be addressed.
 
Again, I thank you for your time. 
 
 
Karen Hatter