2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC5
  



  

  
Submitter : 
  

  
Dr. Richard Dutton
  

  
Date & Time: 
  

  
09/11/2006 10:09:50
  



  

  
Organization : 
  

  
R Adams Cowley Shock Trauma Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Public Hearing on the Conduct of Emergency Clinical Research, October 11, 2006, Food and Drug Administration



Abstract of Presentation



Presenter: Richard P. Dutton, MD MBA

  Associate Professor, University of Maryland School of Medicine

  Director, Trauma Anesthesiology, R Adams Cowley Shock Trauma Center



Address: Division of Trauma Anesthesiology

  Shock Trauma Center

  University of Maryland Medical Center

  22 South Greene Street

  Baltimore, MD  21201

  

  410-328-0125 (office)

  410-328-3138 (fax)

  

  Email:  rdutton@umaryland.edu



Introduction: The protocols for emergency clinical research are of enormous importance to physician scientists working every day to save the lives of injured citizens.  As one of those scientists I wish to share my experience with the Committee, and would be happy to make a brief oral presentation.



Content: I will speak briefly of my background and of my clinical and research experience in this arena.  I have participated in the conduct or design of more than one dozen emergency clinical research protocols, and currently serve on the steering committee of two large multi-center trials that would like to use this mechanism.  In addition, I will present pre-publication information we have collected at the Shock Trauma Center on the ability of trauma patients or their next of kin to provide consent for research studies. This prospectively gathered data, covering more than 2,000 trauma center admissions in the past 6 months, will provide a valuable insight into the actual nuts-and-bolts of emergency patient care and research.



Questions to be Addressed: My presentation will provide insight into question 2c (practicability of the emergency research measures), question 4 (other challenges, specifically brain injury, intoxication, and language barriers), question 5 (the feasibility of community consent mechanisms),

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 question 8 (the opt-out process), question 10 (the role of the IRB), and question 17 (how to motivate timely disclosure of results).  I would be pleased to address any other topics that the Committee wishes, based on my experience in this field.