2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC44
  



  

  
Submitter : 
  

  
Dr. Tom Aufderheide
  

  
Date & Time: 
  

  
10/25/2006 08:10:10
  



  

  
Organization : 
  

  
Dr. Tom Aufderheide
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I strongly support the exception to informed consent requirements as currently written.  As a clinical researcher in this field with experience implementing three prior clinical trials using exception to informed consent under emergency circumstances, I believe 21 CFR 50.24 optimally balances the need to improve emergency care while protecting the rights of human subjects.  



I also suggest consideration of a national IRB evaluating exception to informed consent protocols if it were implemented as an optional resource to the investigator.