Office of Human Research Affairs

iRIS UPDATES

 iRIS ANNOUNCEMENTS - 

 

1/25/2021: Protocol Exception Request Form Updates
 

The Einstein IRB has updated the protocol exception request form to include a question about time-sensitivity.  In addition, the form now asks for updated contact information for the PI and person overseeing the submission.  Note: A protocol exception is defined as any temporary deviation from the protocol that is approved by the IRB prior to implementation, e.g., enrollment of a subject who does not meet the eligibility criteria. 

 

If you have any questions, please email irb@einsteinmed.org.

 

12/17/2020: Progress Report Form Updates 

 

The Einstein IRB has just released an update to the progress report form and progress report review process.  The majority of these updates are being done to improve compliance with IRB approval expiration deadlines. The updates include:   

 Progress Report Form 

  • Progress Report Questions 
    • Added a question that requests a brief summary of activities conducted since the last review.
    • Now require a corrective and preventive action plan for protocols that have expired.
    • Added a new Progress Report for Humanitarian Use Devices
    • Progress Report for Exempt Research 
    • Now displays the Exempt Category as determined by the IRB during the initial review
  • Final Page 
    • Added PI contact information
    • Now displays current list of study contacts and encourages research team to update this list via an Amendment. Only the PI and study contacts receive communications from the IRB (e.g. notification of approval, issues requiring revisions, etc.). 

 Expiration Notifications 

  • Included guidance on how to request an exception to continue to provide treatment to currently enrolled subjects.

 Approval letters 

  • New approval letters: Added guidance on how to prevent a lapse in approval
  • Progress report approval letters: If a study has expired, included information that future expirations may be reportable to OHRP/FDA.

If you have questions about the progress report process or any IRB matters, please reach out to irb@einsteinmed.org.

 

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 9/1/2020: Updated Guidance on Unblinding  

 

As of today, the Einstein IRB is “retiring” the Unblinding Form in iRIS.  Going forward:  

  • No unblinding request form can be submitted in iRIS.  All unblinding requests should be made directly to the pharmacy and should be consistent with the unblinding criteria described in the protocol.  
  • If the unblinding process is not (adequately) described in the protocol, an amendment will need to be submitted to the IRB. 
  • When there's an urgent safety concern, a single episode of unblinding would not necessarily need to be reported to the IRB.  That said, if an unblinding is prompted by an unanticipated problem or deviation, that event would require reporting by the PI in iRIS; the unblinding would be included in the narrative. Please see:
  • Going forward, the unblinding plan will be part of the initial protocol review.  Any amendments to add unblinding criteria will also receive IRB review.   Suggested template language for unblinding is provided in the IRB application in iRIS.  The language is:
  • Subject treatment assignments will remain blinded until the final subject has completed follow up and all data has been recorded and validated.  Urgent, immediate unblinding due to medical emergency may be authorized by the Investigator.  When possible, the treatment assignment will be provided to the treating physician in order to maintain the blind for the Investigator and study staff. 

If you have questions about this new process, please reach out to: 

Kathleen O'Connor, RN, BSN   

Associate Director, Research Audit 

koconno@montefiore.org
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