2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC9
  



  

  
Submitter : 
  

  
Dr. Keith Wesley
  

  
Date & Time: 
  

  
09/11/2006 10:09:05
  



  

  
Organization : 
  

  
Wisconsin State EMS Medical Director
  



  

  
Category : 
  

  
State Government
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 It is vital that pre-hospital emergency medical care research continue. Informed consent is not fully possible when dealing with the study of drugs and tools used to care for people in life-threatening conditions. However, research in this area must continue if we are to base therapy on evidence based criteria.



I urge the FDA to conintue the previous criteria waiving informed consent standards for emergency care research. I am confident that the current IRB process will ensure that the safety and welfare of the public is protected while at the same time furthering the progress of science.



Keith Wesley, MD

Wisconsin State EMS Medical Director

Dept. of Health and Family Services

Bureau of Local Health Support and EMS