2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC40
  



  

  
Submitter : 
  

  
Dr. Richard Levine
  

  
Date & Time: 
  

  
10/18/2006 10:10:28
  



  

  
Organization : 
  

  
Dr. Richard Levine
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 A. Scientific Aspects of Emergency Research and Human Subject Protection

  


  

  


  

  


  

  



  

  
1. Are the criteria for allowing studies conducted under 50.24 adequate to protect human subjects and to promote scientifically rigorous research
  


  

  



  

  
 At the October 11 hearing (yesterday), several discussants advocated a Central IRB or national advisory board to provide 1) expertise and evaluation of proposed emergency research without consent (the results of which might be provided to local IRBs), 2) adjudicate the appropriate levels of risk and perhaps, therefore, the extent and types of community consultation (especially for large multi-site studies), and 3) function as a primary IRB, the actions of which local IRBs could accept/add local issues to, or guidance to FDA/industry/NIH/other funding bodies.  None of the advocates of a Central Emergency Research IRB stated whether such a function should be mandatory in any particular situations, or a respected voice available to researchers on a voluntary basis.  The possibilities would lie in the details, of course.  I commend to the panel the existing example of the National Cancer Institute's Central IRB (See details at www.ncicirb.org).  When this project was being set up as such a body to work with local IRBs with the blessing of OHRP, I was the creator of most of the detailed policies/text at the web site (an employee at the time of Westat, Inc, and a consultant to the NCI.  As part of this function, I developed the approach to and spoke with >100 IRB Administrators to encourage them to participate with the NCI).  Especially potentially useful for an Emergency Medicine Central IRB would be the section on the web site, ("How it works" : "Division of Responsibilities Between the Central IRB and Participating Local Institutions". You will see that this activity meets the rules and guidances covering sharing IRB functions.  There are other sections on that web site which might provide additional precedents for other aspects of a potential Emergency Medicine Central IRB.  I would also be willing/happy to provide more information on that history or opinions on adapting that model for an Emergency Research Central IRB.

Contact Info: Richard Levine, MD

              Cell phone: 301-266-0132

              e-mail: mdconsultant2001@yahoo.com

Thank you for your attention.