2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC39
  



  

  
Submitter : 
  

  
Mr. Sean Davis
  

  
Date & Time: 
  

  
10/18/2006 10:10:21
  



  

  
Organization : 
  

  
Mr. Sean Davis
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 B.  Additional Human Subject Protections

  


  

  


  

  



  

  
6.  What aspects of community consultation as currently practiced are effective mechanisms for human subject protection?
  


  

  



  

  
 To increase human subject protection patients should be required to opt-in, not to opt-out of a study.  The current system is totally ineffective. Consent of patients, patients guardians or next of kin should be required before involuntarily enrolling patients in emergency research studies.

  


  

  


  

  



  

  
 7.  Are there elements of community consultation, both procedural and substantive, that should, at a minimum, be required (e.g., types of information presented, number and types of meetings or interactions, number of people reached)?

  


  

  


  

  



  

  
 Community Consultation in any form is insufficient as a prerequisite for Emergency Research unless every person in the study area is individually contacted.  Then each person must choose to opt-in to the study, requiring people to wear bracelets to opt out is frankly insulting - it creates a burden on the individual without compensation or consent.  



Even with full disclosure to the entire community people traveling in an area may find themselves in the hospital and involuntarily enrolled into one of these studies.  That is unacceptable.  Only people living in an area that have been informed and consented should be allowed into these studies.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
 8.  Would opt-out mechanism (e.g., advanced directives, jewelry similar to medical alert bracelet/necklace, and driver's license indicators to identify individuals who do not wish to be included as subjects in particular emergency research studies pr

  


  

  


  

  



  

  
 Creating an burden on individual citizens to find out about each of these studies and then obtain braclets to opt-out of this is a terrible idea.  If anything people should be required to have braclets to opt-in.    Making this part of a drivers license process is much more acceptable - however it fails to address the fact that some studies place patients at  signifigantly greater risk when they are in medical peril.  

  


  

  


  

  


  

  


  

  
Public Disclousre Prior to Initiation
  


  

  



  

  
 12.  Are there certain types of information (e.g., adverse event reports, study protocol, informed consent document) that should, at a minimum, be publicly disclosed to the communities in which the clinical investigation will be conducted and from w?

  


  

  


  

  



  

  
 Not only do the above things need to be disclosed publicly, consent from either the patient, the patients guardian, spouse or other family member must be required.  It is entirely unacceptable and should be illegal for research to be conducted that may endanger a patient without consent.  The fact that this happens today disgusts me.  This is a violation of the rights of someone who is incapable of defending themselves.

  


  

  


  

  


  

  



  

  
 13.  Should the full protocol, or other information such as the investigator's brochure, for emergency research be available (e.g., through FDA's public docket, clinicaltrials.gov) to the general public before initiation of the clinical investigation

  


  

  


  

  








  

  
Yes, all of the above should be available for all emergency research.