2006D-0331
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC38
  



  

  
Submitter : 
  

  
Dr. Rexann Pickering
  

  
Date & Time: 
  

  
10/18/2006 10:10:02
  



  

  
Organization : 
  

  
Methodist Healthcare
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 IV. IRB Responsibilities -

    * Post-study disclosure plans (at least preliminary) should be part of

      pre-approved plan.  May need modifying after study complete, but 

      need to be part of original plan.

    * Clarify that establishment of DSMC is responsibility of sponsor

VI. Sponsor Responsibilities -

    *  bullet point #6 include documentation of IND or IDE

    *  bullet point #9 define "promtply"

VII.Clinical Investigator Responsibility -

    *If unable to obtain consent, does responsibility to subject or LAR

       cease; no mention in public disclosure of feedback to subject or

       LAR; need to include.  If subject regains consciousness what

       about reconsenting?  At what point does the subject know he/she

       is in a reseach study?

     *Statment reads, "FDA encourages sponsors & clinical investigators

       to provide public access..."  For what time period is disclosure

       required or how many times?  Need time period.

     *Indication is that sponsor will bear costs for community consulta-

       tion.  Need caution added about avoiding amount that will bias

       or skew community attendance or input.

VIII.  Community consultation -

     * Section A Im portant for ORB/sponsor/PI to determine how payment

         will occur for study test article. (ie - will various insurance

         companies pay or toatl paid by sponsor)  Clear guidance needed

         prior to community consultation for disclosure to public.

Page 16 - Before Study Begins - 

     * Under Publicly disclosed information - Clarify is full protocol

         available for public viewing or review.

     * If advertisements require IRB approval prior to dissemination, the

         public disclosre information should also have IRB approval prior

         to dissemination.

Page 19 - Public disclosure after study is completed


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
      *"When" document states "...a reasonable period of time.."  This is

         much too vague.  Need at least some guidance or there will be

         interpretation from 1 day to 1 year.

Page 21 - After Administration of the Test Article

     * "When" - Not on the flow chart; should be included. Also need to

          consider litigation time frames.



The flow chart is helpful.  Should definitely include in the guidance.  Also, once the guidance is final, the flow chart would be a helpful tool on the FDA website.



Thank you for the opportunity to respond and your consideration of these comments.