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Did You Know?

VAIRRS Project Cover Sheet Update

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.




 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

At the end of 2023, the VAIRRS Support Team incorporated a standard numbering catalogue system into the existing naming convention used for all forms within IRBNet and SharePoint. Most forms in the library already used the numbering catalogue system, but it has now been implemented across the board to improve user navigation within the library.

During the first half of the new year, the VAIRRS Support Team will be performing a retrospective functional audit of all documents that comprise the Standard Form Library within the VAIRRS SharePoint and IRBNet. The purpose of this audit is to assess aspects of document functionality and make updates as needed to ensure users have access to high-quality, standardized forms and templates. This will include migrating existing forms and templates into a new document format.




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

Reminder: New Project Submission Forms were the latest forms to be revised and were released on October 25, 2023. All New Project Submission Forms must be used as of January 2, 2024. 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.” 




VAIRRS University

VAIRRS University added three new “How-To” guides for researchers, IACUC administrators, and IACUC reviewers who provide oversight of VA research with animals in IRBNet. Users can access the documents within VAIRRS University either by selecting the role or navigating through the “Additional Resources” section under the “Training Material Categories.”

Note that these documents are dated, so it will be easy to track when new versions are released. These documents will also be posted on the VA Animal Research website.

Admin: 2023 11 29 VAIRRS Step-by-Step IACUC Admin.pdf (VA network access only)
Reviewer: 2023 11 29 VAIRRS Step-by-Step IACUC Reviewer.pdf (VA network access only)
Researcher: 2023 11 29 VAIRRS Step-by-Step Researcher.pdf (VA network access only)

To learn more about VAIRRS University, watch the recording of the VAIRRS University walk-through webinar, led by VAIRRS experts.

For questions about VAIRRS University, 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 VAIRRS Mentor Program infographic

The VAIRRS Mentor Program currently has six team members from various roles across the VA providing mentorship, with a backlog of mentees awaiting the availability of a mentor.

We currently have 10 mentor vacancies. Please let us know if you would like to nominate a potential VAIRRS Mentor. Applications are accepted on an ongoing basis until all mentor slots are filled.

If you are interested in helping fellow VAIRRS users, you can access the mentor application via the VAIRRS Mentor Program SharePoint page (VA network access only).




VAIIRS Multi-Site and Expired Studies Data Validation

The first expired email notification was sent on December 12, 2023. Thank you all for your receptiveness and feedback. Please note that the expired email notification was sent to users that are on the site administrators, ACOS, and AO listservs.




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 VAIRRS January Change Control Board (CCB) meeting, the following requests were approved. The documents listed in the table below have been updated and added to the ORPP&E Standard Form Library within IRBNet and the VAIRRS SharePoint. Updates from the February meeting will be announced in the March newsletter.

January CCB Meeting Updates




VAIRRS STUDY TEAM TRACKING

Reminder: The new Study Team Tracking (STT) wizard is available in the IRBNet as of December 11, 2023. The wizard outline is posted on the VAIRRS SharePoint portal under the ORPP&E Standard Form Library menu option. The personnel tracking data previously collected in the Project Cover Sheet (PCS) wizard will be collected in the STT wizard. The Outside Compensation and Financial Conflict of Interest responses will be collected in the STT wizard.

Study teams will be required to complete the new STT wizard for new submissions and to report changes in study team members.

Outside Compensation Reporting

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:

  1. PIs may email (or some other method outside of VAIRRS) outside compensation information to ACOS or a designee within the research office
  2. ACOS can obtain approval from AO
  3. Committee Administrator may create a ‘Special Events’ package in the IRBNet R&DC workspace
  4. Committee Administrators can upload an approval memo as a Board Document and publish it as internal only

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. 



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