IRB Information Sheet Wizard Completion Campaign

Have you checked your sites' IRB Information Sheet wizard completion rate recently? There are currently more than 20 sites with a completion rate of 50% or less. 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 May 16, 2023, there are 976 active projects related to COVID-19 research taking place at 83 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?

VAIRRS University

VAEDA

VAIRRS Strategic Advisory Council Updates

The VAIRRS Strategic Advisory Council (VSAC) recently met to review current personnel tracking processes. The VSAC determined personnel tracking should occur separately from project coversheet tracking. This will provide a more efficient means of updating study personnel and associated training requirements. The VAIRRS team is working on a draft personnel tracking form. Further updates will be provided as development progresses.

VAIRRS MAY AMBASSADOR:

VA PITTSBURGH HEALTHCARE SYSTEM

VAIRRS Experience:

VA Pittsburgh converted to VAIRRS in March 2021. Project investigators and coordinators were required to attend a training before submitting any packages or projects. Each review committee received trainings specific to local practices and their workflow. 

The experience has been different for each committee. The Institutional Review Board (IRB) previously utilized a SmartForm-based program. As part of the transition, researchers were required to submit a package that included the wizards, staff form, data collection forms and any participant-facing materials. The greatest challenge for users was adapting from SmartForms to wizards and paper forms.

The experience from the Institutional Animal Care and Use Committee (IACUC) was very different as researchers had to transition from emailing paper study documents to uploading them into the system, as well as the introduction of the wizards. Additionally, committee members had to become more proactive in accessing the projects by completing reviews and participating in general meetings. 

Through continued use of the system, VA Pittsburgh learned to identify common errors and how best to address them. Reviewing new projects has enabled VA Pittsburgh to become more comfortable with the system and advise their research community.  

VA Central IRB and Upcoming Training Courses/Webinars

The VA Central IRB (CIRB) is currently updating all submission forms. The new submission forms will provide improved instructions, better usability and have also eliminated redundant questions in order to provide a more efficient experience for the research team. In addition, the VA CIRB is making minor changes to some of its processes as well as the respective forms. 

The new VA CIRB submission forms and process changes will be released in two scheduled phases in June. The VA CIRB will announce each release on its website, as well as in the VAIRRS monthly newsletter, email communications to stakeholders and webinars. 

The first VA CIRB webinar is scheduled for June 13, 2023, titled, "VA Central IRB: Continuing Review Process and Form Changes". This webinar will provide an overview of changes to the PS/SC and LSI continuing review forms and process. Study teams and research office personnel are highly encouraged to attend this webinar in order to understand the transition process and the changes to forms and the continuing review process. 

Please stay tuned for more updates from the VA CIRB regarding the release of new submission forms and process changes. Each release will provide a list of new submission forms, description of changes and a date for when the new submission forms must be used. If there are questions about this process, you may contact the VA CIRB at vacentralirb@va.gov. 

NOTE: As a reminder and to begin preparations for the release of new submission forms, please continue to always download VA CIRB 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. 

VAIRRS Mentor Program

We are proud to feature our new mentors on the VAIRRS Mentor Program SharePoint page! Mentor and mentee applications can still be submitted throughout 2023. You can access the mentor/mentee applications via the SharePoint page.

If you have questions about the VAIRRS Mentor Program, please contact the VAIRRS Support Team at VAIRRS@va.gov.  

Mentor Spotlight:

Meet our first mentor, ​​​​​​​Jeannie Helton!  ​​​​​​​Jeannie Helton is a Research Compliance Officer at the Tennessee Valley Healthcare System. She has worked at VA for nearly 17 years and has succeeded in many different roles over the course of her career. She enjoys finding new opportunities for improvement for reducing areas of noncompliance. Jeannie was part of the team that implemented IRBNet at VA TVHS in 2012 and is a supporter of IRBNet, saying, “I have seen how the system has transformed our processes over the last 11 years… I wish we had a mentor and mentee system when we made the transition, and I see great value in sharing some of the lessons learned and providing guidance to those that are currently going through VAIRRS transition growing pains.” Outside of work, Jeannie enjoys spending time with family, traveling, and scrapbooking.

BACK TO BASICS

LEARNING CORNER

ORPP&E is hosting a webinar next week!

IRBNet TOPICS

Action: You Spoke, We Listened

CONCERN

It is difficult to manage research training because expired CITI training records are downloaded into the researcher's IRBNet training profile.

SOLUTION

To easily identify which completed records are currently effective, assign flag colors for specified training types. This can be done by clicking on the Track Training button on the left-hand sidebar and then clicking on the Manage Types and Flags link. Configure flag colors under the research administration workspace, and set other workspaces to "Use the Document Types and Tracking Flags" from the research administration. 

Since the designated flag colors will only appear for accepted records that are currently effective (i.e. not expired), this will allow you to quickly identify active training records via the Project Team Tracking function on the Submission Detail page, or via the "Show Roll-Up by User" option on the Track Training and Credentials page. Refer to the IRBNet Energizer - Tracking Training and Credentials, which is located in the administrator pathway of VAIRRS University. 

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. Please submit your suggestions to VAIRRS@va.gov. 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

• VAIRRS June Webinar
• New Personnel Tracking Form 
• External Committee Guidance

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