iRIS Update - 2019 Q4

By: Sue Tindall

What’s new in iRIS?

Lots to be proud of over this last year!  As you know, IRBO is working continuously all year to improve the iRIS system to be more streamlined and user friendly.  Some of the changes being made for you in last few months are outlined below:

• 02 Upgrade – A new “look & feel” of the system will be implemented at the end of December. While all study activities and workflow behave the same, most of the changes lie in the appearance of the Dashboard Layout. Improvements include:
  • cleaner look & feel
  • shortcut activities that take you to relevant sections of your workspace
  • customizable filters on workspace, that remain in place (‘sticky filters’)
  • ability to view study data, status, and history on the dashboard level.
  • revisions to KSP sections that later in 2020 will allow us to transition the community into moving all KSP into one section 3
  • ability to create ‘study pools’ of KSPs, which you can later add to a study with one click
  • ‘drag & drop’ document functionality
• Consent Form Stamping – finalizing consent documents in iRIS has been slightly revised, and the IRB analysts will now be stamping all Initial Reviews (IRs) and Amendment (AMs) automatically via iRIS. Consents are no longer sent to OPS post-IRB approval, to process and “stamp.”  Study teams now receive approved consent documents in real time (at the time of receiving their IRB approval outcome letter). 
• Scientific Review Pilot – The NCI, NHLBI, and NINDS continue to pilot the revised Scientific Review Form and gather their feedback for IRBO to implement into the SRC project. Once this is completed, IRBO will engage all ICs in the implementation/roll out of using iRIS to complete their Scientific Review form required by Dr. Gallin in iRIS as well.  This way, all ICs are conducting this important review in the same way, in one system, allowing for consistency and critical reporting data.
• IRB Outcome Letters Improvements – You may notice a difference in appearance of your IRB Outcome letters. Due to the final acquisition of all IC’s IRBs under IRBO and Panel 1, we took this time to optimize our letters.
• Continuing Review Reminder Notices – You may notice a difference in appearance of your Continuing Review Reminder Notices. This was done because some minor inconsistencies needed to be corrected.
• Revision to Routing Signatures Language - Based on the MEC’s recent revisions to signature requirements, iRIS  has been revised to reflect this in the routing signatures language.  Please review carefully all signature language in your submissions for any revised requirements, which are summarized here:
  • Initial reviews: PI and Branch Chief or CD must sign.  If the PI is the CD, then the SD must sign.
  • Amendments and CRs: PI signoff only.  No Branch chief/CD signature required.

• New Progress Report Form - A new single submission form will take the place of the former separate Continuing Review and Study Closure forms. There will now be one single form for the following three types of submissions:
  • Continuing Review
  • Study Closure
  • Progress Report*
    (*This is a new, brief, institutional “check-in” required for minimal risk studies that the IRB has approved on or after Jan 21, 2019 under the revised Common Rule and has determined to not require continuing review.)

New Progress Form update:

The IRB is now requesting at the time of continuing review, that for protocols which have enrolled any subjects since the last review, a redacted copy of the last signed consent for each of the approved forms be attached. 

The responsibility to ensure that research is conducted as approved by the IRB and in accordance with the regulations and institutional policies is a responsibility that is shared by the institution, the investigator and the IRB.  This can and should be accomplished in a number of ways, including monitoring by the research team, by external bodies (including regulatory agencies), as well as by the IRB.  It is a responsibility of the IRB to assure at the time of continuing review that the protocol is in fact being conducted as approved.  An explicit goal of monitoring is to detect problems at their earliest stage. Problems with informed consent documents are among the most frequent compliance findings, which can lead to adverse findings in sponsor and/or regulatory audits. By reviewing the submitted consents, the IRB will be doing a “spot check” for compliance with the consent requirements as outlined in the protocol.  We hope this will allow for us to identify any issues that can then be brought to the research teams attention for corrective measures.