Institutional Review Board

iRIS Newsletter - November 2013

Attention:
  • This email contains important information about the Einstein IRB’s new software (iRIS).    
  • Please read this entire message as it affects everyone involved in conducting human subjects research at YU/Einstein, Montefiore, Jacobi and NCB.    
  • iRIS software is used by both the East Campus and West Campus IRBs. 
 
iRIS Screenshot 

The Einstein IRB is excited to announce that iRIS is now ready for Full Board submissions! 

  • Today: You may begin entering full board studies in iRIS. (Note that a new "Consent/HIPAA template (for Full Board/Greater than Minimal Risk studies)" is now available under the help menu and at http://www.einstein.yu.edu/docs/administration/institutional-review-board/forms/consent-gtmr.doc. All new studies submitted in iRIS need to use the updated "iRIS" consent templates.    
  • January 1, 2014: All new studies must be started in iRIS only. (Paper forms and PATS applications will no longer be available for any new submissions.)   
  • January 1, 2014: The CITI requirements in iRIS will be modified. See “New CITI Training Requirement” below. 

Updated iRIS Roll-out Schedule 

Use of the software is being phased in as outlined below:  

  • Phases 1-2 (Current/Active): iRIS is required for all new Exempt and Expedited applications for submission to the East and West Campus IRBs.   
  • Phase 3a (Effective December 2013 Meetings): iRIS is available for new Full Board applications for submission to the East and West Campus IRBs for those who want to take advantage of this opportunity. (Paper/PATS submissions will still be accepted.)   
  • Phase 3b (Effective February 2014 Meetings): All new Full board applications will only be accepted via iRIS and will be assigned to the "next available meeting." (Paper/PATS submissions will no longer be accepted – please plan accordingly.)   
  • Phase 4 (Schedule to be announced shortly): Existing studies will be “converted” to iRIS.  Researchers, please note that we will need your assistance to verify the conversion data and add missing information in order to proceed with subsequent IRB transactions such as Progress Reports and Amendments.  

The Einstein IRB will keep the research community informed throughout this process via a series of emails.
Up-to-date iRIS information is also available at: http://www.einstein.yu.edu/irb/education/iris.aspx
 


New CITI Training Requirement 

Effective January 1, 2014, iRIS will verify completion of the CITI Conflict of Interest module. Completion of both the COI module and a human subjects course by all Key Personnel (including research coordinators) will be required in order for submissions to be accepted by iRIS. 


iRIS Tips 

  • Get started early. First time users need time to go through one-time initialization steps (obtaining/verifying username/password, activating iRIS account for each Key Personnel, synchronizing CITI Training information, etc.)   
  • Attend a training course (see: http://www.einstein.yu.edu/administration/institutional-review-board/education/iris.aspx#training) and/or use the Researcher Handbook (available for download within iRIS).   
  • Verify that the PI and all Other Investigators have completed an electronic COI disclosure within the last 90 days. (A list of everyone's last COI date is available from the Help Menu in iRIS.)   
  • Verify that the PI and all Key Personnel have completed CITI information in iRIS. (Submissions with any KP missing CITI completion information are halted by iRIS automatically and need to be retracted and resubmitted once the problem is resolved.)   
  • Track your submission to ensure that signatories sign off promptly and that it reaches the IRB.   
  • Have questions? Check out our iRIS FAQ: http://www.einstein.yu.edu/administration/institutional-review-board/education/iRIS/FAQ.aspx  
  • Still have questions? Contact iris-support@einstein.yu.edu   

More iRIS Information 

The process of transitioning to the new iRIS software will require extra effort on everyone’s part, but the final outcome will yield significant benefits to the research community.  As we move forward, to assist with the transition, there are user guides, optional training sessions, and one-on-one assistance. 

  • Some of the many features and benefits of iRIS include:
    • Paperless submission (all study documents are attached electronically and submitted through the software).   
    • Streamlined submission process.   
    • Electronic signatures (applications can be routed to PIs and chairs for electronic sign-off/approval).    
    • Dynamic application form (presents relevant questions based on the answers you provide).   
    • Multiple browser support (iRIS can be accessed using most browsers from PCs and Macs).   
    • Easy access to consents (all approved (stamped) consent forms and other study documents will be easily accessible in iRIS).    
    • Single portal access (post transition, researchers will be able access all of their Einstein IRB (East and West) research protocols in one place).   
    • Full board protocols will be assigned to the next available meeting (24/year).   
     
  • Important changes to the submission process that coincide with the release of iRIS: 
     

For information on how to access iRIS, please visit the iRIS FAQ: http://www.einstein.yu.edu/administration/institutional-review-board/education/iRIS/FAQ.aspx 

User guides/handbooks are available for download within iRIS. 

iRIS training schedule and registration information is available at: http://www.einstein.yu.edu/irb/education/iris.aspx#training 

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