alert graphic is a stylized exclamation mark

Please carefully review our COVID-19 information hub for updates on IRB processes during the COVID-19 outbreak.

Skip to end of metadata
Go to start of metadata

 Release Notes

The release notes for each version can be found below.

2020.12

December 2020 iRIS Release Notes

On the afternoon of December 18, 2020, the iRIS team will be making some improvements to the iRIS system.  This will occur between 12 and 5 pm EST, and will NOT result in any system downtime.  The summary of changes/improvements to be made are below: 

  • The Amendment Form has been revised/improved.
    • A few of the amendment form questions have been revised to:
      • Improve the question text
      • Allow the user to tell the IRB more information about study instruments, and scripts/letters used to inform participants
      • There is also a place now in the form to attach Information Letters and Verbal Scripts that will be given to participants
      • Also, a new question has been added to ask how many participants are currently in follow-up only
  • The system will now require Principal Investigator signoff during the submission process.
    • The PI's name will automatically be selected in the routing list. This will be implemented for:
      • Initial Reviews
      • Amendments
      • Progress Reports
    • Things to keep in mind now that this is turned on:
      • You will not have to manually select the PI anymore within the routing list
      • If the submitter is different than the PI, and the submitter does not check themselves in the routing list for signoff, the form will be editable to the PI when they receive it for the PI's signoff
      • If the PI is out of office, they will need to designate an individual for Alternate Signoff. This can only be done by the PI. A guide will be available on how to perform this action in iRIS Helpful Documents.
  • The system will now block submission of multiple Amendments, or multiple Progress Reports at once.
    • The system will now block the submission of more than one amendment at a time, or more than one Progress Report at a time. If the user tries to submit more than one of these at a time, they will see the following message:

NOTE: Nothing prevents the simultaneous submission of one progress report and one amendment.

  • Section 6.2 Study Application–revised to contain new questions about the INdian Health Service IRB/Tribal IRB
  • Section 10.1 & 10.2 Study Application–revised to more clearly describe accrual ceilings of various sites
  • Help text added–KSP Section of the Study Application has been revised to more clearly describe the roles of each user listed in each section. This was also revised on the amendment form
NIH iRIS Training Offerings
Recurring Help Sessions

The iRIS Training Team continues to offer recurring "Ask the iRIS Trainers" brown bag sessions each month.

Next Session: Wednesday, January 19, 2021 - 12:00 pm to 1:30 pm EST via WebEx.

You can access the session here.

Please mark your calendars.

These recurring monthly "Ask the Trainer" brown bag lunchtime sessions will be held panel-style. Users should come prepared with their general questions for all to learn from. We hope that you join us! They have been very well received, and we have been grateful for your questions and insight!

New User Trainings

If you have a new person on your team who will be using iRIS, please have them email iris_training@od.nih.gov for Intro to iRIS Help and 1:1 assistance. In addition, they may find helpful user guides and tutorials on our IRBO Website, under Resources.

Group Trainings

If your IC or department would like group training sessions pertaining to iRIS, please email us by request at iris_training@od.nih.gov. 

Support

If you have any questions about any of these changes, please feel free to contact the IRB main line or inbox for process-related questions (phone: 301-402-3713 / email: IRB@od.nih.gov ), or iRIS Trainers for system-related questions (iris_training@od.nih.gov). 




2020.05

May 2020 iRIS Release Notes

The IRBO is working continuously to improve the iRIS system to be more streamlined and user friendly.  Some of the changes made for you in April are below.  You will see these changes in the system by this evening, May 1, 2020:

Study Side Changes
  • New Not Human Subjects Research (NHSR) Determination Application:

In an attempt to streamline the submission forms, the NHSR form has been revised.  It is now created by logging into iRIS, going into your Study Assistant workspace, and clicking the Create a New Study button at the top of the page (see screenshot).  We think you will find the rest of the process rather simple as this request now has a dedicated application.  No more backing out of the Initial Review submission form, etc.!

Indicates the position of the Not Human Subjects Research Application within the Create a New Study menu.



Changes to the Regular Study Application
  • New External Funding Question:

As part of AAHRPP reporting requirements, we have added a new question to section 5 of the Study Application, asking about External Funding.  

Displays the external funding question in iRIS

  • Reorganized Ancillary Review Questions in Study Application:

In an effort to streamline the study application, we have moved the ancillary review questions to all be sequentially located in the form.  IBC, RSC, and GDS questions now reside in Section 5 – General Information for IRB Use.

  • Revised Radiation Safety Committee Review Question:

As a result of changes to the way effective doses of radiation are calculated and reviewed for NIH protocols, a revised question for Radiation Safety Committee review has been added to Section 5 of the Study Application. 
NOTE:  The former radiation question - Previous Section 9, (Ionizing Radiation) has also been removed.

List of options in section 5 of the study application in iRIS

  • New COVID Question

A COVID question has been added to the Study Application, as well as the NHSR Application:

COVID question in the Study Application in iRIS

(Study Application)


COVID question in the NHSR Application in iRIS

(NHSR Application)


  • Added "PRIA Approval" to the Study Documents on IR:

All protocols that are conducted in the Clinical Center (CC) or using CC resources need to complete the PRIA form in iRIS and submit it at the time of Scientific Review.  When you receive back the completed PRIA approval, you need to attach that approval to the Initial Review submission form as you do with other ancillary reviews (RSC, IBC, DEC, etc.)

Indicates the PRIA Approval option on the Attach Study Documents section in iRIS


Support

If you have any questions about any of these changes, please feel free to contact the IRB main line or inbox for process-related questions (phone: 301-402-3713 / email: IRB@od.nih.gov ), or iRIS Trainers for system-related questions (iris_training@od.nih.gov). 




2020.03

March 2020 iRIS Release Notes

The IRBO is working continuously to improve the iRIS system to be more streamlined and user friendly. One of the efforts that our iRIS team is undertaking during Q1 this year is to optimize and increase the effectiveness of all iRIS Submission Forms. The end goal is to simplify the overall workflow by only having a handful of basic submission forms – Initial Review, Amendment, Progress Report, Single Patient Use, Single Patient Planned Deviation Request, and Reportable Events.

This afternoon (March 27, 2020), the iRIS team will implement a revised Amendment form that will take the place of some other, miscellaneous submission forms. This is described in more detail below. You will see these changes on the p.m. of March 27, 2020.


REVISED Amendment Form:

A revised Amendment submission form will be implemented. It will continue to serve as the standard Amendment Form, as well as take the place of the following separate submissions forms:

  • Investigator Brochure Submission Form
  • KSP Changes Form
  • Participant Recruitment Materials Form
  • Miscellaneous Documents Submission Form
  • Short Consent Approval Form
  • DSMB or SMC Outcome Letter Submission
  • Outside IRB documents for multi-institutional trials

Where to find the form:

The form location is unchanged. It still resides within your study page, where you usually find all of the submission forms.

How the form works:

Page one of the amendment form will ask which type of changes you want to request:


Notable changes to the Amendment Submission Form:
  • Menu of Changes:

New information/Changes that used to have their own separate submission forms* in iRIS will now be sent to the IRB on this revised Amendment Form, and simply indicated on the page 1 checkbox “menu of changes” list.

(*described above – ex. Investigator Brochure Submission Form, KSP Changes Form, Participant Recruitment Materials Form, Miscellaneous Documents Submission Form, etc.)

  • Key Study Personnel (KSP) Section has been revised:

To clean up the KSP functionality, this section has been slightly revised to better describe what personnel should be added where. In addition, we have run a task to move the Accountable Investigators and Lead Associate Investigators to a more appropriate section. The task moved personnel on each study from the “Research Support Staff” group, to the “NIH Employee Investigators” group. This will be visible on the Study Summary page and Key Personnel page for all studies. However, like any KSP amendment, those changes won’t appear on the study application until it is revised/converted. If you want to verify presence of study personnel, they can be verified in Study Summary or Key Personnel sections under the “Study Management” tab.

You will also now be able to include ALL personnel who are in NED in the Key Personnel section of iRIS. Staff who were previously listed in section 4 of the study application should be moved, with your next amendment submission, into section 3C of the study personnel section. This way the training for those investigators will be able to be tracked in iRIS easily (you will be able to see their training status now) and those investigators will also have access to the study in iRIS (they did not when listed under section 4).

  • Improved Summary/Rationale of Changes

The amendment form now asks for a more robust summary and rationale for EACH change requested. This will give the IRB all the information and rationale they need to adequately review the changes, and reduce queries sent back to the team in pre-review.

  • Removal of Duplicative Data

Questions that were duplicative (asking information already present in the protocol) have been removed from the amendment submission form. This is an ongoing effort on the IRBO’s part to eliminate double entry and potential for inconsistencies.

  • Users can now create Amendments for Single Patient Use Submissions

Previously, to amend a Single Patient Use Submission Form, users would submit a Follow-Up Submission Form as a work around. We have added the ability for users to now submit Amendments to Single Patient Use Submission Forms.


Implementation:

After the revised Amendment Submission Form is implemented, you will no longer have the option to create any new submission forms of the following types:

  • Investigator Brochure Submission Form
  • KSP Changes Form
  • Participant Recruitment Materials Form
  • Miscellaneous Documents Submission Form
  • Short Consent Approval Form
  • DSMB or SMC Outcome Letter Submission
  • Outside IRB documents for multi-institutional trials

If you have any of these forms already submitted to the NIH IRB on March 27, 2020, these will be processed to completion as is and NOT completed on the revised Amendment form. If, however, you have any of these forms in DRAFT state when we implement the revised Amendment form on March 27, you will have to delete them and use the revised Amendment form to submit this request.


Training/Education:

A user guide for the new form will be sent out on the day of the release, March 27, 2020. It will also be posted on the IRBO website under Training and Education > iRIS Training.


Please note this guide can now be found on the iRIS Helpful Documents page.


Support:

If you have any questions about any of these changes, please feel free to contact the IRB main line or inbox for process-related questions (phone: 301-402-3713 / email: IRB@od.nih.gov ), or iRIS Trainers for system-related questions (iris_training@od.nih.gov).



2020.01

January 2020 iRIS Release Notes

IRBO is working continuously to improve the iRIS system to be more streamlined and user friendly. Tonight after close of business, the iRIS team will implement some new features, including a combined Continuing Review & Study Closure form, called a Progress Report Form. This is described in more detail below.

NEW Submission Form:

"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.)


Where to find the form:

The new combined form resides under your study with the rest of the submission forms.


How the form works:

Page one asks which type of submission you want to complete, and then only displays the sections and questions you need for that submission type. This should streamline continuing reviews and study closures when it is determined at the time of renewal that a study is eligible for closure. This way, the form type can simply be revised and resubmitted with the appropriate data, instead of being retracted and submitted as a new submission type.


Implementation:

After the new form is implemented, you will no longer have the option to create a NEW Continuing Review Form and Study Closure Form. Those forms will be removed. In their place, will be the single Progress Report Form, and within that form you can then select the submission type. If you have any Continuing Reviews and Study Closures already submitted to the NIH IRB after close of business Feb 7, 2020, these will be processed to completion as is and NOT completed on the new form. If, however, you have any Continuing Reviews and Study Closures in DRAFT state after we implement the new Progress Report form at close of business Feb 7, you will have to delete them and use the new Progress Report form.


Training/Education:

NOTE: User guide for the new form is attached to this notification. It will also be posted on the IRBO website under Training and Education > iRIS Training.


Please note this guide can now be found on the iRIS Helpful Documents page.


Support:

If you have any questions about any of these changes, please feel free to contact the IRB main line or inbox for process-related questions (phone: 301-402-3713 / email: IRB@od.nih.gov ), or iRIS Trainers for system-related questions (iris_training@od.nih.gov).




2019.12

December 2019 iRIS Release Notes

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 December’s release at 4 p.m. today are below:

  • v11.02 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
  • User Guides – User guides highlighting the differences in appearance for Study Side and Review Boards are attached.
  • Demos – IRBO is hosting demos on the Study Side changes via webinars on a recurring basis in the weeks to come. These will also be recorded and hosted on the IRBO website and can be found here: Study Side Tutorial Please note this instructional video can now be found on the iRIS Demonstration Videos page.

  • Consent Form Stamping – iRIS consent stamp has been slightly revised, and IRB analysts will now be stamping all IRs and AMs themselves. They will no longer send these to OPS post-IRB approval, to process and stamp. OPS will post the consents that are provided to them by the IRBO.
  • 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 all of their Scientific Reviews 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.


Support:

If you have any questions about any of these changes, please feel free to contact the IRB (phone: 301-402-3713 / email: IRB@od.nih.gov ) or iRIS Trainers (iris_training@od.nih.gov). As usual, if you experience a problem or bug with the system you may submit a ticket to the iRIS Help desk - https://iris.helpdesk.nih.gov.





2019.10

October 2019 iRIS Release Notes

As you know, IRBO is working continuously to improve the iRIS system to be more streamlined and user friendly. Some of the improvements made for you in October are below. You will see these changes by the end of business on November 1, 2019:

  • Revised routing of forms to Panel 1: The system was revised to automatically route forms to Panel 1, as the other IRB panels roll into Panel 1 IRB. Specifically, Gen Med 2 and Gen Med 4 IRB’s forms will now automatically route in iRIS to Panel 1 IRB.
  • Revised Signature Role list in IRB Application: The list of roles in section 3.4 of the Study Application has been cleaned up so that only relevant roles are left in the list. Also, Deputy Clinical Director of PI has been added to the list at the request of NIDCR.
  • New Study Document Category (applies to DEC only): "COI NIH Employee" has been added to the study document category list, at the request of the DEC Office.
  • Revised lists on the IRB side (applies to IRB Analysts only): The lists of roles, study statuses, and review outcomes have been revised and cleaned up in the system.


Support:

If you have any questions about any of these changes, please feel free to contact the IRB (phone: 301-402-3713 / email: IRB@od.nih.gov ) or iRIS Trainers (iris_training@od.nih.gov). As usual, if you experience a problem or bug with the system you may submit a ticket to the iRIS Help desk - https://iris.helpdesk.nih.gov.