2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC11
  



  

  
Submitter : 
  

  
Mrs. Lillian Kehoe
  

  
Date & Time: 
  

  
09/11/2006 10:09:20
  



  

  
Organization : 
  

  
Citizen
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I cannot believe you are even considering this action.  This really scares me and gives me visions of Mengele and the Nazis.  Under no circumstances would this be a good idea.  There must be informed consent either by the patient or their representative to perform experiments on them.