2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC12
  



  

  
Submitter : 
  

  
Dr. Henry Halperin
  

  
Date & Time: 
  

  
09/12/2006 09:09:38
  



  

  
Organization : 
  

  
American Heart Association
  



  

  
Category : 
  

  
Health Care Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I would like to make a presentation at the upcoming meeting on October 11 on behalf of the American Heart Association Emergency Cardiac Care committee.



See the attached manuscript that describes the comments we would like to make.

  


  

  


  

  


  

  


  

  



  

  
2006D-0331-EC12-Attach-1.DOC