Institutional Review Board

IRB Newsletter - August 2013

 

   

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Einstein IRB Newsletter
August 2013
 

  

Table of Contents (click a link for more details):  

  1. NEW! Reportable Events Policy and Forms  
  2. Additional New and Recently Revised Policies  
  3. Additional New and Recently Revised Forms  
  4. Human Research Seminar Series 2013-2014  
  5. iRIS Update  
  6. Newsletter Archive  

 

  

Einstein IRB News  

  1. NEW!  Reportable Events Policy and Forms
    This new comprehensive policy replaces the Internal Adverse Event Policy, External Adverse Event Policy and the Deviation Policy. The reporting requirements have been simplified and now reflect the latest federal guidance. New reportable event forms are also available (see below). Special seminars are available (Mon 8/12 @ Einstein and Thu 8/15 @ Montefiore) to review the changes associated with this new policy. For more information about this policy (including answers to Frequently Asked Questions), please visit the Reportable Events Information page.
     
    • Reportable Event Form – For filing an initial report of a reportable event (except for Protocol Exception requests – see separate form below). 
    • Reportable Event Follow-Up Report – For providing additional outcome information related (not available at the time of the initial report).  
    • Protocol Exception Request Form – For requesting IRB approval to of a temporary deviation from the protocol prior to implementation, e.g., enrollment of a subject who does not meet the eligibility criteria.  
    • AE Log – This is a sample log that you may use to record adverse events as required under the policy. Note: For greater than minimal risk studies, the log must be submitted to the IRB as part of the annual review of the protocol.  
    • Deviation Log – This is a sample log that you may use to record deviations as required under the policy. Note: For greater than minimal risk studies, the log must be submitted to the IRB as part of the annual review of the protocol. 
  1. Additional New and Recently Revised Policies
    The following policies were recently revised as part of our ongoing behind the scenes efforts to bring conformity to our policies and procedures.  Please take a few minutes to review the changes: 
     
    • Case Report Policy – This new policy describes the requirements and applicability of IRB review and consent/authorization for single- and multiple-case-reports. A new Authorization for Publication of Case Report is also available (see below).   
    • HIV Guidelines – These guidelines were revised to reflect recent changes to the NYS Public Health Law related to HIV testing. 
    • Registration of Clinical Trials – This revision updates the policy to more clearly explain the requirements (from FDA and ICMJE) to register, and post results of, clinical trials at clinicaltrials.gov. 
  1. Additional New and Recently Revised Forms  
  1. Human Research Seminar Series 2013-2014
    The IRB is in the final stages of planning this year’s Human Research Seminar series. Watch your email for the announcement of the seminar topics and the opening of registration. You’re also welcome to review the handouts from the 2012-2013 seminars. 
  2. iRIS Update
    iRIS, the IRB’s online application software, has been in use for Exempt and Expedited studies since January – hundreds of studies have already been submitted. The IRB is currently completing the configuration of the full board studies section – watch your email for an update this fall. In the meantime, learn about iRIS, sign up for an iRIS Training, or review the iRIS Frequently Asked Questions (FAQ).
     
  3. Newsletter Archive
    This and prior IRB Newsletters are available in the IRB Newsletter Archive.
     
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