Office of Research & Development |
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The personnel tracking section of the Project Cover Sheet wizard will now be included in the following new wizards:
Investigator Tracking wizard (for investigators only) which includes information previously tracked in the ePromise Investigator Profile.
Study Team Tracking wizard (for study team tracking only) which includes Financial Conflict of Interest and Outside Compensation (new!) reporting.
If you would like to learn more about the new wizards, the recording of the VAIRRS monthly webinar: "New Wizards" is available.
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 May/June and July/August Change Control Board meetings, the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint. The next VAIRRS Change Control Board meeting is scheduled for September 28, 2023.
CCB Meeting |
Form |
Summary of Changes |
May/June |
3.16L Directors Certification International Research |
New form added to library. |
May/June |
3.17L Directors Certification Pregnant Women |
New Form added to library. |
May/June |
3.18L Directors Certification Children |
New form added to library. |
May/June |
3.18L Directors Support Prisoners |
New form added to library. |
May/June |
2.1 Request for Waiver of HIPAA Authorization |
Removed the following language from Section VI. regarding Central Privacy Board because it does not apply to field sites: "If the Central Privacy Board Reviewer has a conflict of interest, check the box and return to the Central Privacy Board Administrator." |
May/June |
7.18R Reviewer Checklist Amendment |
Added an additional checkbox option for the following: "The proposed amendment or modification involves informed consent or conveying new information; the participants who have already consented to participate need to be reconsented or informed." |
May/June |
7.19L IRB Amendment Approval Expedited Convened Letter Template |
Added the following question to fulfill requirements from VHA Directive 1200.05 § 17c : "If the proposed amendment or modification involves informed consent or conveying new information, do participants who have already consented to participate need to reconsented or informed?" |
May/June |
7.2A Combined ICF and HIPAA Authorization Template |
• Will have access to your research related health records OR, • Will not have access to your research related health records. This includes language clarifications from VHA Privacy.
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July/August |
7.0A Request for Waiver of Documentation of Informed Consent |
Removed signature line from Section V. |
July/August |
7.1A Request for Waiver or Alteration of Informed Consent |
Removed signature line from Section V. |
July/August |
7.12A Request to Transition to the 2018 Revised Common Rule |
Updated the functionality of the PDF version and added a MS word version. |
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 data entered into the RCO audit module, released in Spring 2023, is ready for export. RCOs who would like an aggregate extract of the FDC data must contact the IRBNet Help Desk at govsupport@irbnet.org. As a reminder, the RCO must have entered audit results into the audit module to receive an extract.
As of June 28, 2023, the VA Central IRB has released the first and second phase of new forms which are posted in the VA Central IRB IRBNet Forms and Templates library.
The VA Central IRB will announce the third release of the remaining New Project submission forms on the VA Central IRB Website (VA Central Institutional Review Board (IRB)) and email communications in late September or early October. The release of these remaining forms is pending a concurrent update to the VAIRRS IRB Information Sheet and other new wizards. Please stay tuned.
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.
In August, VAIRRS University added training materials from the Office of Research Reviews (ORR) in the "Additional Resources" section. The webinar recording and slides, which demonstrate how to use the Technical Reference Model (TRM) Global Research Tags and the ORD Global Tags report when searching to identify approved and preferred software for use in VA Research projects, are available at https://tinyurl.com/57548v3n (VA network access only).
If you would like to learn more about VAIRRS University, the recording of the VAIRRS University walk-through webinar is available. The presentation is led by VAIRRS experts who dive into the details of the new training library.
If you have questions about VAIRRS University, please contact the VAIRRS Support Team at VAIRRS@va.gov.
Click below to watch tutorials on how to create and submit COI disclosures within VAIRRS:
Are you a VAIRRS superuser? Are you the local go-to for all VAIRRS-related questions? If so, the VAIRRS Mentor Program needs you! We are currently recruiting mentors to assist users who are seeking to improve their knowledge of VAIRRS. Serving as a VAIRRS mentor is a rewarding (and reimbursable!) experience. We currently have 12 mentor vacancies, and our goal is to fill at least half of the remaining slots in the first wave by December 1, 2023.
Mentor applications can be submitted throughout 2023. You can access the mentor/mentee applications via the VAIRRS Mentor Program SharePoint page.
We are working through your data validation responses and expect to follow up this month. In most cases, we will reach out to each site to either confirm your updates or reconcile projects. If you have not already reviewed and validated your multi-site data and updated/corrected expired studies, please do so as soon as possible and notify the VAIRRS Support Team at VAIRRS@va.gov once validation is complete.
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. |
FIND Pro Launched on June 13, 2023.
How FIND Pro empowers researchers:
Types of Documents included: All VA and VHA Directives, all VA and VHA Handbooks, ORD Program Guides–1200 Series, ORD Guidance and ORD FAQs.
Check It Out!
Office hours: Recurring office hours via Microsoft Teams started July 2023 and are held the second Tuesday and the fourth Wednesday each month. To attend the next sessions, select the links below:
Tuesday, September 12, 2023, 3:00-3:50 PM (EDT)
Wednesday, September 27, 2023, 12:00-12:50 PM (EDT)
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.
During the July/August Change Control Board meeting the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint.