2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC68
  



  

  
Submitter : 
  

  
Dr. Claudia Robertson
  

  
Date & Time: 
  

  
11/28/2006 08:11:42
  



  

  
Organization : 
  

  
Baylor College of Medicine
  



  

  
Category : 
  

  
Academia
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 A. Scientific Aspects of Emergency Research and Human Subject Protection

  


  

  


  

  


  

  



  

  
2. Are the following criteria easily understood and, if not, how can they be clarified?
  


  

  



  

  
 The emergency exception from informed consent is absolutely critical to make progress in the treatment of critically ill or injured patients.  We would like to comment on the question of whether 'Practicably (50.24(a)(4))' is easily understood.



The determination of whether research could practicably be carried out without the waiver is difficult for IRBs to make. For example, if an investigational treatment must be given immediately, then there is no question that the study is impracticable without the emergency consent exception. On the other hand, if the treatment can be given within a 24 hour window,  the emergency consent exception is unlikely to be needed. However, when the therapeutic time window is, for example,  3-6 hours, there is a gray zone.  Within that time frame, researchers may be able to contact appropriate surrogate consent givers, but may not be able to get written informed consent because the relatives are in transit to the hospital or need time to deal with the impact of the injury or event.  



Additional guidance for IRBs on what would be considered impracticable within the intermediate time windows would be helpful.  In addition, some thought should be put into an intermediate solution between waiver and written informed consent. For example, obtaining approval to initiate the study (perhaps even a time-limited approval) by phone, followed later by a more detailed written informed consent to continue participation in the study, might be more acceptable than a complete waiver of consent.