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Did You Know?

VAIRRS Project Cover Sheet 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."




 IRBNet Configuration Notifications




The auto-generated notifications can be customized for your site. Please contact IRBNet Support at govsupport@irbnet.org for more information. 




 Committee Member Recusal Function

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 Library Updates

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 review the proposed changes to the forms/letters and send your feedback to the VAIRRS Support Team inbox at VAIRRS@va.gov.

ORPP&E Standard Form library changes

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. 

ORPP&E Standard Form library changes




VAIRRS Strategic Advisory Council

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.

RCO Module

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.

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.




VAIRRS University

VAIRRS University added four new documents, provided by the Central IRB, that give guidance on the PI and LSI New Project Submission process and PI and LSI Exempt Project Submission process

The documents include two process flows, with accompanying instructions. Users can access the documents by going to the VAIRRS University SharePoint page (VA network access only) and clicking the link at the bottom of the homepage for a full list of all of the resources. Once the list of resources loads, users can use the search bar to locate the specific document.  

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.




VAIRRS COI Module

Click below to watch tutorials on how to create and submit COI disclosures within 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.




VAIIRS Multi-Site and Expired Studies Data Validation

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). 




ISSO PO Reviewer Designation

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.

ISSO PO Reviewer Designation table VAIRRS Research Administration Workspace
VAIRRS Research Administration Workspace

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.




Focused Inquiry Navigation Database (FIND Pro)

FIND Pro Launched on June 13, 2023.

How FIND Pro empowers researchers: 

  • Returns relevant and rank ordered search results regarding VA research policy, guidance and FAQs.
  • Provides a portal to ask ORD policy experts questions. As questions are typed, key word searches are being made in the background, and results are presented before the question is even submitted.
  • Offers a mechanism for the researcher to provide feedback that is read and discussed by the FIND Pro team and escalated to ORD leadership as needed.

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!

  1. Open the tool by going to https://tinyurl.com/mruyyfez(VA network access only).
  2. First time users: Accept permissions for FIND Pro to connect to your Office 365 Outlook Account and SharePoint Account. This is safe and has been approved by the OI&T VIPR team. Please see https://tinyurl.com/u6sc24tf(VA network access only) for further instructions.
  3. If you need help or would like more information:

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)




Privacy Officer Guidance

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.

  1. Correcting the header “Health Information Portability and Accountability Act (HIPAA)” to “Health Insurance Portability and Accountability Act (HIPAA)”.
  2. Clarifying/providing instruction on when a combined ICF/HA can be used. (NOTE: This is the same language provided for the commercial IRB informed consent template language as provided on the ORD page IRB Relationships in the VA: Single IRB Exceptions, Independent (Commercial) IRBs and changing IRB reliance by the VA Facility for consistency).
  3. Updating paragraph three to, “While it is not the intent of this study, other information such as HIV status, drug, alcohol or STD treatment, genetic test results or mental health treatment may be viewed or collected, if necessary or if there are interviews or surveys where you, as the research subject, provide that information to the research team. (If your research study plans to collect any of this information delete the phrase “While it is not the intent of this study” and start the sentence with “Other Information”.)”
  4. Updating paragraph four to, “The research team may also need to disclose or share your information to others as part of the research and study progress. Others may include the following: {MODIFY AS APPROPRIATE: VA Cooperative Studies Program (CSPCC); CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC); CSP Site Monitoring; Auditing and Review Team (SMART); CSPCC’s Human Research Committee (HRC); Food and Drug Administration (FDA), Office of Human Research Protections (OHRP), the VA Office of Research Oversight (ORO), the Government Accountability Office (GAO; Sponsors; Contractors; Affiliates as appropriate), the VA Institutional Review Board and the local VA medical facility Human Research Protections Program.”




Change Control Board

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.

  • 7.0A Request for Waiver of Documentation of Informed Consent
  • 7.1A Request for Waiver or Alteration of Informed Consent
  • 7.12A Request to Transition to the 2018 Revised Common Rule (updated the functionality of the PDF version and added a MS word version)






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