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 New Policies!!!

 

Please visit our Policy and Guidance section to discover udated information about:

  • Reporting Protocol Deviations, and Adverse Events (UPIRSOs)

  • Consenting Spanish Speaking subjects

  • Continuing Review information. 

 

  • Effective 3/7/12, all qualifying new studies must contain the following language in the patient informed consent document.  The Sunrise Health IRB will begin requiring this statement with new studies submitted for the January 2012 meeting.  Studies approved by the Sunrise Health IRB prior to 12/31/11 do not require this language to be inserted into the consent form.  For your convenience, we have had this language translated into Spanish.  If you choose to cut and paste this statement into an existing consent form, please ensure that the formatting is consistent with the original document.  Modified consent forms must be submitted with an amendment form to the IRB for approval prior to issuing to a patient. This administrative change meets expedited review criteria.  Again, note that studies approved by the Sunrise Health IRB prior to 12/31/11 are exempt.  

     

     

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    THIS STATEMENT MUST BE INSERTED VERBATIM.  UNDER NO CIRCUMSTANCES CAN THE STATEMENT BE REVISED.

     

    A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

     

     

     

     

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