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Failure to reply to an IRB request within 30 days (continued)

  1. Automatic action if you fail to reply within 30 days - New studies and Revisions:
    The database will automatically withdraw your submission. If you wish to have this submission reconsidered you must not only resubmit it in its entirety but also be sure to address the issues identified by the IRB.
  2. Automatic action if you fail to reply within 30 days - Continuing Reviews, Adverse Events, Miscellaneous items, etc:
    Since the review and approval of these items could impact the safety to subjects already enrolled in the trial they will be forwarded to a Chair for review. If the Chair determines there are no safety concerns, the submission will be withdrawn. If this occurs and you wish to have this submission reconsidered you must not only resubmit it in its entirety but also be sure to address the issues identified by the IRB. Conversely, if the Chair determines there is potential risks to subjects then the submission along with your failure to respond will be forwarded to the full Board for consideration.

Effective immediately (January 10th) all of our "need reply" type letters (Tabled, Explicit Changes, etc) have been changed to instruct investigators of the new 30 day timeline to submit a response.

While our letters reflect the policy change now (01/10/2006) we will not turn on the "30 day clock" until February 1st, 2006. As a result please be advised that the policy will be in full effect on that date. Failure to reply within 30 days to any and all letters generated by the IRB on or after February 1st, 2006 will result in the automatic process described above.

NOTE: this announcement was distributed (1) in the January 2006 edition of the IRB newsletter, and (2) via e-mail to the IRB-01 e-mail list (IRBMAIL-L@lists.ufl.edu) on January 06, 2006. The information was also published previously in the IRB-01 Policy and Procedures Manual.

 

 

 
     
 
 
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Updated: 06/08/2007 10:25 AM


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