Office of Research & Development |
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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.
During the August Change Control Board (CCB) meeting, the following four requests were approved.
August CCB Meeting Updates
Form/Letter/Wizard |
Summary of Changes |
Event Report Checklist for Reviewers |
The removal of any Central IRB branding, the addition of a checkbox to section five question three that specifies whether the PSET ticket has been closed and the date of closure, the addition of the package number in parenthesis to section 1 next to IRBNet ID, and lastly, under the instructions section the language was changed from “Refer to VHA Directive 1058.01 and the VA Central IRB Table of Reporting Requirements for definitions, reporting requirements and timeframes.” To "Refer to VHA Directive 1058.01 and applicable committees or local policies for definitions, reporting requirements, and timeframes." |
3.13L RDC Approval Letter |
The inclusion of the list of submission documents at the conclusion of the letter, following the signature. |
6.1A SRSS 10-0398 RPSS |
Updating the link to the schedule of controlled substances and the correct references. |
7.1A Request for Waiver of Alteration of IC |
Updating the description of the form title in IRBNet. |
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.
New in October, VAIRRS University added the Principal Investigator (PI) Change Instructions User Guide. This guide outlines how to change a PI within IRBNet once a project is active. It also includes step-by-step instructions on how to update the PI between research institutions.
Users can access the PI Change Instructions User Guide within VAIRRS University by navigating to the Training Material Category and selecting “VAIRRS User Guides” or via https://tinyurl.com/4bk7wu5n (VA network access only).
To learn more about VAIRRS University, watch the expert-led VAIRRS University Walk-Through Webinar recording.
For questions about VAIRRS University, contact the VAIRRS Support Team at VAIRRS@va.gov.
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.
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.
Reminder: The Enterprise Research Data Security Plan (ERDSP) Wizard is live. This tool streamlines the process for obtaining centralized information security reviews from the Office of Research Reviews. 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.
If you haven't already completed the VAIRRS Data Evaluation Survey, please do so as soon as possible. We request that individuals in the following roles at all VA research sites to please complete this survey:
The data collected will help shape the future of the VAIRRS program as we continue to enhance our services and support for all VA research sites.
A targeted email was sent to administrators at all sites on June 3, 2024. If you did not receive the email, please use the following link: https://forms.office.com/pages/responsepage.aspx?id=Ixtf6a-r7kWCHberJRqzv-oQQLNcNq9HtCyVCy1xValURDJZUk45Wkg3WEtOVjQ0UUUzTDJIREtOUC4u (VA network access only). Also, be sure to update the VAIRRS Distribution subscription list, so that you can receive important surveys and updates in the future.
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 VAMCs to facilitate the adoption of VAIRRS and increase compliance with related protocols and directives. The support team works closely with VAMCs, for an average duration of six to nine months, assisting in pre- or post-submission validation of VA Project Cover Sheets, translation of board actions from a site's local database to IRBNet, consolidation of duplicate projects, and rectification of data discrepancies. If your VAMC is interested in assistance, please send an End User Support request to VAIRRS@va.gov to begin the onboarding process.