IRB Information Sheet Wizard Completion Campaign

Have you checked your sites' IRB Information Sheet wizard completion rate recently? As of November 8, 2023, we have reached a 71% completion rate. As a reminder, all human research projects must complete the IRB Information Sheet wizard. Projects under the oversight of an affiliate or external IRB are also expected to complete this wizard. Please continue to work with your investigator community to ensure awareness of the IRB Information Sheet requirement. Thank you! 

DATA SHOUTOUTS

COVID-19 Research Dashboard

As of November 15, 2023, there are 959 active projects related to COVID-19 research taking place at 80 VA Medical Centers across the country.

The projects submitted to VAIRRS can be easily tracked via our COVID-19 Research Dashboard. The COVID-19 Research Dashboard allows users to search studies by specific topic and/or location.

The COVID-19-related projects submitted to the VAIRRS platform support and advance VA's clinical and research missions, ultimately helping Veterans affected by the disease.

DID YOU KNOW?

Wizard Update

The revised IRB Information Sheet wizard is live. The updated wizard outline is posted on the VAIRRS SharePoint portal under the ORPP&E Standard Form Library menu option. You may also view the updated wizard in the IRBNet sandbox.  

On October 24, 2023, CIRB hosted a webinar that reviewed VA Central IRB forms and process updates and changes to the IRB Informational Sheet wizard. You can view the webinar recording on the ORD Webinar archive.

On December 6, 2023, a revised version of the Project Cover Sheet (PCS) wizard will be deployed in the sandbox. The updated PCS will include the following additions:

1. On the PCS PDF both the "Funding Source Code" and the "Funding Source Code - Other" response will now appear.
2. The IRB of Record Type will appear for all studies that select "Data and/or biospecimens from living human individuals."

Expired Projects Notifications

Based on your feedback, the VAIRRS Support Team delayed the expired projects email notification launch to include an audience exclusive to site administrators, ACOS, and AOs.  Based on the data within IRBNet and VAIRRS Dashboards, we identified that facilities had an excess of projects that reflect as expired projects due to a lapse of administrative updates to the projects in IRBNet. The expired projects email notification is intended to serve as a reminder to research administrative staff regarding projects that have passed the expiration date or are about to expire within the next 30 days. The notification also ensures that new expiration dates are reflected in IRBNet.  After we detail the email notification in our December webinar, we will send out an automated email notification regarding the number of expired studies to each facility's AO, ACOS, and administrators once a quarter (every three months).

Newsletter Summaries

As a result of feedback regarding newsletters, starting in November, VAIRRS will send out targeted email communications that summarize relevant information within newsletters and program updates that pertain directly to your role (i.e. administrators or investigators/end users). These summaries will be delivered in short, digestible formats so that users can easily read and stay abreast of important news and updates from VAIRRS.

VAIRRS Mentor Program

The VAIRRS Mentor Program currently has four mentors providing support to seven mentees, with several additional mentees awaiting the availability of a mentor. 

We currently have 12 mentor vacancies. Please let us know if you would like to nominate a potential VAIRRS mentor. Our goal is to fill the first wave of remaining slots by December 1, 2023. 

If you are interested in helping fellow VAIRRS users, you can access the mentor application via the VAIRRS Mentor Program SharePoint page. 

VAIRRS University

ORPP&E Standard Form Library

To improve accessibility of forms within the ORPP&E Standard Form library before the new year, we will be implementing a standard numbering catalogue system to the naming conventions of all forms within IRBNet and SharePoint. Most of our forms already use the catalogue system but we will be implementing it across the board to standardize and improve user navigation within the library.

ACTION REQUESTED:

We need your help with reviewing suggested changes to the following forms/letters in IRBNet. Please use the link(s) in the table below to review the proposed changes to the forms/letters and send your feedback to the VAIRRS Support Team inbox at VAIRRS@va.gov.

UPDATES:

During the VAIRRS October Change Control Board (CCB) meeting, the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint. On the VAIRRS SharePoint you can reference the full summary of changes for each form. Updated forms will be published no later than November 17, 2023. The next VAIRRS Change Control Board meeting is scheduled for November 30, 2023. 

VA Central IRB

Over the past four months the VA Central IRB has updated most of the submission forms. All new forms are now posted in the VA Central IRB IRBNet Forms and Templates library. New Project Submission Forms were the latest forms to be revised and were released on October 25, 2023. Prior to using these new forms, please read the Summary of Changes – CIRB New Project Forms for a detailed list of forms and process changes. For additional information regarding these changes, you may also refer to the VAIRRS Webinar from October 24, 2023, titled “CIRB Forms and Process Updates.”  Please note all New Project Submission Forms must be used by January 2, 2024. If there are any questions or if submission assistance is needed, please contact the CIRB Manager responsible for your project, a CIRB Administrator, or the VA Central IRB general mailbox at VACentralIRB@va.gov for support. As a reminder, please continue to always download VA Central IRB forms directly from IRBNet Forms and Templates library (VA Central IRB Administration, Washington, DC – Documents for Researchers) when they are needed to ensure the current version is being used and submitted with a package.

VAEDA

Dashboards

The following updates are live in the Field Staff Reporting (FSR) Dashboard. In addition, we updated the user experience interface to allow more filters by adding a collapsible filter panel.

1. The latest IRBNet hyperlinks for each project go directly to the IRBNet record (individuals require existing permission to specific submission to access)
2. New “Drill Throughs” to new Review Process, and Review Tracking pages to identify length of time that reviewers & committees take to review a project
3. Animal Research page to include animal projects identified through the PCS “Project Characteristics” section of the form

LEARNING CORNER

ORPP&E is hosting a webinar next month!

Data Integrity 101

HELP DESK AND TEAM RESOURCES

IRBNet support is available at govsupport@irbnet.org for technical issues and questions related to IRBNet. For regulatory questions or questions about processes subject to regulatory guidance, visit the ORD FAQs page and use the search tools to find the answer. If you still need help, email VAIRRS@va.gov. The VAIRRS User Group Listserv is also available if you would like to reach out to other users. Email the VAIRRS team to be added to the listserv.

Training resources and the VAIRRS Toolkit are available on the VAIRRS SharePoint portal.

The VAIRRS Change Control Board meets monthly to review requested changes and potential new forms and letter templates. If you wish to submit a change request visit the VAIRRS CCB Request Form. Reminder: It is expected that all VAIRRS sites will use the standard library and supplement with local forms as necessary. The Project Cover Sheet and IRB Information Sheet wizards must be completed at the next study event as soon as possible.

LOOKING AHEAD

• 2023 Wrap Up
• 2024 Outlook
• Happy Holidays!

Thank you,

VAIRRS Support Team

VAIRRS WEBSITE:  https://www.research.va.gov/programs/orppe/vairrs/default.cfm

VAIRRS SharePoint:  https://dvagov.sharepoint.com/sites/VHAORPPE/VAIRRS

ORD Policy and Guidance FAQs:   https://www.research.va.gov/resources/policies/faq-search.cfm