2006D-0331
  

  
  Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC13
  



  

  
Submitter : 
  

  
Mrs. Judie  Brown
  

  
Date & Time: 
  

  
09/13/2006 07:09:16
  



  

  
Organization : 
  

  
American Life League
  



  

  
Category : 
  

  
Other Organization
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Division of Dockets Management (HFA-305)

Food and Drug Administration 

5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852  



To whom it may concern:



Having completed a review of the 30-page Guidance for Institutional Review Boards, Clinical investigators and Sponsors Exception from informed Consent Requirements for Emergency Research, we are left with a single overriding concern.



The proposal appears to place an inordinate emphasis on the role of third parties in the decision making process for those patients who, for whatever reason, are unable to provide the appropriate required consent prior to becoming a guinea pig in a trial involving an unapproved drug.  



Clearly there could be abuses of this proposal.  For example, if the patient was facing certain death and was unable to defend his right to live out the balance of his life naturally, there could be callous disregard for his dignity.  The patient could even be subjected to trials that could be considered unthinkable if the subject was a laboratory chimpanzee rather than a human being.



The same could be true of the comatose patient whose family or physicians look upon him as less than human because he can no longer communicate with them.  One can also envision problems for those severely disabled patients whose caregivers may see the value of the emergency research as being more beneficial to society as a whole than to the one who will become the research subject.



In a nation of almost 300 million people, we find it terribly hard to understand how there could ever be a situation in which a patient would be exposed to emergency research without being permitted to give his properly informed consent.



The best way to resolve these potential abuses of the human person would be for the FDA to make a hard and fast rule that no human subject will be exposed to clinical trials for any reason unless he or she has personally given informed consent.  Anything short of that borders on inhumane abuse of the most vulnerable in our midst.



Sincerely yours in the Lord who is life,



Judie Brown, President

American Life League, Inc.


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 JAB/krw