2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC52
  



  

  
Submitter : 
  

  
Dr. Jeff Cheek
  

  
Date & Time: 
  

  
10/31/2006 07:10:26
  



  

  
Organization : 
  

  
University of Washington
  



  

  
Category : 
  

  
Academia
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 1. The proposed guidance applies only to FDA-regulated studies.  There is no indication that the federal Office of Human Research Protections (OHRP) will follow this guidance, if it is adopted by FDA.  This is important because some of the emergency medicine research waivers are granted to projects that are federally-funded, but not FDA-regulated.  If OHRP adopts the guidance, there may be inconsistencies between the guidance and OHRP regulation about the definition of a human subject, and the criteria an IRB uses to assess whether study risks are minimal or not.  Will FDA coordinate implementation of the proposed changes with other signatory agencies regulated by the Common Rule? 



2. The guidance requires the IRB to provide the sponsor with approved disclosure plans and materials prior to initiation of the study.  Heretofore, this responsibility has been delegated to researchers.  We are concerned that shifting the paperwork burden from the investigator to the IRB detracts from the IRBs ability to review, modify and approve protocols from the entire range of disciplinary studies pursued at academic institutions.



3. The guidance points out a number of documentation procedures for the IRB that are not currently in place.  There will be an additional workload impact on the staff that supports IRBs if the guidance is formalized.



4. There are several areas in which the IRBs might wish to have additional guidance from FDA. 



4a. One area is guidance on when a site is or is not engaged in research.  For example, if the emergency intervention is completed in the field and the only involvement of a hospital is provision of clinical care that would take place independent of the intervention, is the hospital a site engaged in research?



4b. It appears contrary to the intent and text of the regulations to be able to enroll a patient in a trial under waiver of consent for emergency research, give them an experimental intervention, then not be able to ascertain whether they were harmed by it because they decline consent, when those who are sicker (and more likely harmed by the intervention) are less likely to consent.  Extending the waiver of consent through in-hospital clinical record review, so long as identifiable data are protected, would assure an assessment of survival and adverse effects and reduce the potential for bias (Nichol et al., Resuscitation 70:360-368, 2006).



4c. The proposed guideline for community involvement in emergency medical research is especially vague and full of nuance that every IRB interprets them in a different way. As a consequence, the number and type of activities required to obtain IRB approval for a community consultation procedure is highly variable. UW investigators have noted that the individuals who participate in these processes are not representative of the community.  Specifically, few community members show up for town hall meetings, and those that do participate tend to present polarized views (i.e., either strongly for or against the study.)  A practical and more representative approach is to perform random digit dialing of the community that will participate in the study.  Specific guidelines on community involvement would be most helpful to both the investigators as well as the IRBs reviewing the applications in this aspect.