2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  
Submitter : 
  

  
Ms. Debra Jo Endres-Ard
  

  
Date & Time: 
  

  
09/11/2006 10:09:58
  



  

  
Organization : 
  

  
Ms. Debra Jo Endres-Ard
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am very strongly opposed to the possibility of myself or any family member becoming an unconsenting participant in a medical-related trial for emergency research.  Such assumed inclusion is unethical.  Those willing to participate in experimental activities should be burdened with the need to identify themselves as a consenting candidate.  Without a physical means of indicating such, it must be presumed an individual is unwilling and does not grant consent to participate in a medical trial for emergency research.