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The revised Project Cover Sheet (PCS) wizard is available in the IRBNet sandbox the week of December 11. The updated wizard outline (VA network access only) is posted on the VAIRRS SharePoint portal under the ORPP&E Standard Form Library menu option. The VA Project Lead/Principal Investigator and Additional Project Personnel sections moved to the Study Team Tracking wizard. The IRB of Record Type will appear for all studies that select "Data and/or biospecimens from living human individuals." On the PCS PDF both the "Funding Source Code" and the "Funding Source Code - Other" response will now appear.
Study teams will not be required to update previous PCS submissions unless there has been a change to the study.
The auto-generated notifications can be customized for your site. Please contact IRBNet Support at govsupport@irbnet.org for more information.
Recusals can be noted on the Reviews and Minutes page. Under the Voting section, you can add or remove recused committee members, and the recused members will be recorded in the minutes.
VAIRRS approved the following changes to the “7.2A Combined ICF with HIPAA” form during the January VAIRRS Change Control Board (CCB) meeting. Once the form is updated, it will be added to the ORPP&E Standard Form Library within IRBNet and on the VAIRRS SharePoint.
Changes will be made to ensure the ORPP&E and CIRB versions of the Combined ICF and HIPAA are consistent. Additional changes will include the removal of the page range from the form footer and revision of the header title from “RESEARCH CONSENT FORM” to “INFORMED CONSENT FORM AND HIPAA AUTHORIZATION.
Request to Review: The January CCB meeting also approved changes to the Study Team Tracking and IRB Information Sheet wizard.
Read the January CCB Summary of Changes (VA Access Only)
The VAIRRS team encourages you to take a moment to test these changes in the IRBNet sandbox environment.
If you have any questions or feedback regarding these changes, please contact the VAIRRS Support Team.
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. We will provide further updates as development progresses.
The COI and RCO Modules are available for all facilities to use. If your facility is interested in adopting either module, please reach out to IRBNet Support at govsupport@irbnet.org.
The VA Central IRB has released an update to submission processes and forms pertaining to the following:
Please review the VA Central IRB Summary for more details on the changes.
For more detailed information regarding these changes, we also invite you to watch the recording of the VA Central IRB updates webinar.
The forms and guidance documents have been posted in the VA Central IRB IRBNet Forms and Templates library (VA Central IRB Administration, Washington, DC – Documents for Researchers). Please note new forms have a “must use by” date noted in the summary document. On or after this stated date, any package submitted with an old version of a form will be returned for the new form to be submitted.
If you have any questions regarding the forms or processes, please contact the Central IRB manager responsible for your project, the Central IRB administrator for the panel that oversees your project, or the VA Central IRB team at VACentralIRB@va.gov for support.
VAIRRS added a new guide titled "IRBNetNotes-Subsequent_Packages_01.28.2025" to assist researchers and study coordinators with submitting a revised project package. You may be asked to submit a revised project package with updated information for your local committee's review (i.e., continuing review, modifications for approval, changes to the study team, etc.). This guide will help ensure a smooth submission as you maintain an organized set of project documents.
Access the Guide (VA Access Only)
You can also access the guide by going to VAIRRS University and navigating to the Researcher/Investigator/Study Team user role and selecting task area button 13.
To learn more about VAIRRS University, view the VAIRRS University walk-through webinar led by VAIRRS experts.
Watch the VAIRRS University Walk-Through Webinar
For questions about VAIRRS University, contact the VAIRRS Support Team.
Contact the VAIRRS Support Team
For disclosures submitted to the Office of General Council (OGC) Ethics workspace, the "Board Action" in the local COI workspace should be updated to "Forwarded" with the appropriate "Effective Date." The local COI administrator may update the "Next Disclosure Due Date" to send reminder notifications to the disclosure owner.
The ORD Central COI Administrator is responsible for updating the disclosure status once OGC Ethics has completed their review. If no conflict, the signed 450 Alt-VA will be uploaded as a "Board Document" in the OGC Ethics workspace and made available to the disclosure owner.
The VAIRRS Mentor Program currently has four team members from various roles across VA providing mentorship, with the ability to support more mentees.
If you are interested in getting help from a fellow VAIRRS user or becoming a VAIRRS mentor, access the mentee/mentor applications via the VAIRRS Mentor Program SharePoint page (VA network access only).
Mentee applications are accepted on an ongoing basis throughout the year.
Mentor applications are accepted on an ongoing basis until all slots are filled.
The VAIRRS Support Team is expanding the "Expired Projects Email Notification" email to include Project Status and IRB Project Risk Level discrepancies. Expect the new "Data Integrity" email format to launch in mid-June.
When assigning a package for ISSO (information system security officer) or PO (privacy officer) review in the research administration or R&DC (Research & Development Committee) workspaces be sure to select the appropriate reviewer designation from the drop-down list. The ISSO and PO reviewer designations are very helpful when tracking reviewer activity.
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Did you miss this month’s VAIRRS webinar, “How to Properly Utilize the Research Admin Workspace in IRBNet”? If so, you are encouraged to review the webinar recording and available training resources. A summary of the activities discussed at the webinar are highlighted in the table to the left. |
The ORD Focused Inquiry Navigation Database (FINDPro) (VA network access only) tool helps users find information regarding ORD policy related to human, animal, and laboratory research protections. The latest FINDPro updates include:
Please note: The ePROS webpage is also undergoing changes and the URLs will soon be changing from ORPP&E to ePROS. In addition, some content will be reorganized to reflect the new structure of the enterprise transformation. When this happens, please resave your bookmarks. Sorry for the inconvenience.
Recent revisions to the combined Informed Consent Form (ICF)/HIPAA Authorization include the following that begin on page 8 and extend through page 10. This includes language clarifications from VHA Privacy.
As of April 10, 2024, study teams who previously completed an STT Wizard will be required to re-enter the first and last names of all "Additional Personnel" the next time they revise the STT Wizard.
Note, this is a one-time occurrence that will prompt users to revise their STT Wizard the first time they return to their existing STT Wizard following this update.
For any study team that completed the STT Wizard before the Wizard update on the evening of April 10, 2024. When you open the "Additional Project Personnel" page, all names of previously entered personnel on this page will be blank. However, the rest of each person's entry is still completed (contact information, duties, etc.). To know which person's name to fill in the two new fields, scroll down to the "VA email" field, which should identify the correct name. Another option would be to download the previously submitted STT Wizard from Designer and use it to re-enter the names of the additional personnel.
Principal Investigator's (PI) concerned with sharing their or their team’s outside compensation with the rest of the team or the R&D committee can now use an alternative reporting solution, provided below.
Short-term workaround for existing projects:
Rationale:
The R&DC is not required to review outside salaries for existing projects, therefore the submission of information can take place outside of VAIRRS. The workaround meets the requirement for posting the approval memo to the project file, and the only individuals with access to the salary information are the PI who submits, the ACOS, and the Authorizing Official. The R&DC members with access to the project will also have access to the internally published memo. If this is a concern, the Committee Administrator can remove all committee member access or just provide access to the Chair.
The Enterprise Research Data Security Plan (ERDSP) Wizard in VAIRRS streamlines the process for obtaining centralized information security reviews from the Office of Research Reviews (ORR). The wizard provides a mechanism to account for the security of research protocol data during each stage of the data management life cycle while also ensuring consistent evaluation of a research protocol’s data usage, storage, sharing, and transmission methods.
Required for use since November 1, 2024, specifically for new submission, amendment, or administrative updates, the following changes were made to the wizard on November 7, 2024.
With the ERDSP in a wizard format, it can be shared for cloning, such as from a PI to participating LSIs. It is strongly recommended that the ERDSP be reviewed and approved before sharing to avoid duplicating issues.
Please review ORR’s quick reference guide, created to assist investigators during the transition process and includes support links to training and additional resources.
To learn more about the new wizard, please view the ERDSP Wizard Training Webinar from the VAIRRS Monthly Webinar Series archive. Questions related to the ERDSP and Information System Security Officer (ISSO) review should be directed to OISISPSSDCDORR@va.gov.
The VAIRRS governance boards voted to develop an Administrative Checklist Wizard and Continuing Review/Closure Wizard. The Administrative Checklist will be the first board-facing wizard and will support administrative review. We will keep you updated on our progress over the summer. Email the VAIRRS Support Team at VAIRRS@va.gov for more information or if you would like to participate in the development process.
Throughout the year, the VAIRRS team has completed 142 surveys, including 18 total interviews with research sites performing in the top and bottom 10%. There was also a 77% survey penetration rate with 85 unique VA Research Sites represented in the survey. Thank you very much to all those who have participated and helped in providing crucial data to enhance our resources in the upcoming 2025 year!
VAIRRS has launched a new VAIRRS Distribution Subscription List (VA network access only), which will serve as the primary method to receive VAIRRS training announcements, surveys, and data-specific emails outside of the newsletters and program updates. With the launch of the subscription list, VAIRRS is retiring the Microsoft Outlook contact groups: VAIRRSAdministrators@va.gov and VAIRRSendusers@va.gov.
Please update your subscription using the VAIRRS Distribution Subscription List today. Select your VAMC and "subscribe to VAIRRS email."
Note: This subscription list does not include subscriptions to VAIRRS newsletters or other ORD news.
The new Data Curation Email Notification shares the data reported on the Data Curation page of the FSR Dashboard. This notification was sent to all VAMCs on Tuesday, June 18. Please forward these emails to any necessary points of contact for their information and rectification. To be included in these emails going forward, subscribe to the VAIRRS Distribution Subscription List.
The VAIRRS End User Support Team provides administrative assistance to VA research programs to aid in the adoption of VAIRRS, increase compliance with related protocols and directives, and alleviate workload for site administrators. The support team works closely with VA research programs, for an average duration of six to nine months, and can assist with:
If your VA research program is interested in any of these offerings, please send an end user support request to begin the onboarding process.
Send an End User Support Request
Thank you to all VA research programs and staff who expressed interest in participating in the soft launch of the VAIRRS Best Practice Sandbox (BPS)! To our 39 BPS volunteers, the VAIRRS Support Team looks forward to receiving your best practice. Your participation will help shape the future of the VAIRRS program as we continue to enhance our services and support for all VA research sites. Stay tuned for updates regarding the launch of the BPS!
VAIRRS expects to make substantial updates regarding the TMS integration over the coming weeks and will keep research office personnel updated on VAIRRS progress. To keep you abreast of the progress, the following has taken place since the start of the integration:
A gap in the number of IRBNet User Profiles successfully matched with TMS profiles was identified. Efforts to identify research personnel and study team members in
VAIRRS, collaborating with ORD Communications, launched a pilot workgroup to support the publication notification process for VA investigators. During the pilot, investigators from participating pilot sites will submit publication notifications in IRBNet. Investigators are asked to complete a monthly survey to capture feedback and VAIRRS will host office hours to capture additional feedback and for assistance.
If you are interested in participating in the pilot, please email the VAIRRS support team at VAIRRS@va.gov.
VAIRRS will establish a standardized version of the VAIRRS Data Dictionary. We are requesting assistance from the field in this effort. A current version of the Data Dictionary is available through VAIRRS University. A workgroup will begin in 2025, with a proposed first meeting date of Tuesday, January 28, 2025, at 2:30 p.m. ET. If you would like to participate in this workgroup, please send an email response to VAIRRS@va.gov by January 10, 2025.
The MVP provided a streamlined submission and review process for MVP Feasibility Requests. The streamlined guidance, “Guidance Document for MVP Feasibility Request Process for VA Investigators” (link goes through the ORD intranet funding site) replaces the current guidance version (2/14/2024) and can also be found in the VHA ORPPE&E library for human subjects researchers.
A few things to highlight about the updated guidance:
The VAIRRS team looks forward to seeing an increase in the number of projects utilizing MVP data. For the most updated information, please visit https://vaww.research.va.gov/funding/electronic-submission.cfm (VA access only) for guidance and the full process.