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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

During the April Change Control Board (CCB) meeting, the following requests were approved.

April CCB Meeting Updates

FORM/LETTER/WIZARD

SUMMARY OF CHANGES

Study Team Tracking Wizard

Option “g” under the Delegation of Duties section will be adjusted from “prescribe or provide treatment or study intervention (if drugs, list on 10-9012)” to “prescribe or provide treatment or study intervention (if investigational drug(s) without a package insert, list on 10-9012).”

7.2A Combined ICF and HIPAA

Sample text related to optional banking was removed from page 16.

IRB Information Sheet Wizard

The Schedule and Amount of Payments text box will be shifted from a plain text response to a rich text response.




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 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.

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 a new energizer titled, "IRBNet Training Energizer – Submission Coordinator Other Tools_04.2024," which highlights recent updates by IRBNet to the Attendance page of the Minutes Builder. Users can now copy attendance from a previous minutes document, as well as save multiple default sets of attendance lists for use in future minutes. These changes will make it faster for users to complete the Attendance page, as all attendees and designations can now be copied and reused across multiple minute documents.

Users can access the energizer by clicking here (VA Network access only), or by going to VAIRRS University and navigating to “IRBNet Energizers” under the Training Material Categories. Once the list of resources loads, users can scroll down or use the search bar to locate the document.

To learn more about VAIRRS University, view 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

VHA Directive 1200.13, published May 2, 2024, requires use of the IRBNet COI module for submission of the Financial Conflict of Interest (ALT-450). The Office of Research & Development (ORD) will host a webinar on June 18, 2024, at 2:30 PM EDT to discuss implementation and training. IRBNet will host training webinars for FCOI administrators over the summer. The VAIRRS Support Team is also available to assist the research community at VAIRRS@va.gov.




VAIRRS Mentor Program

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, access the mentee application via the VAIRRS Mentor Program SharePoint page (VA network access only). Applications are accepted on an ongoing basis throughout the year.




VAIIRS Multi-Site and Expired Studies Data Validation

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.




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)

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: 

  • The removal of the "ASK ORD" button from the launch page. This allows users to search for information before asking a question, resulting in faster data capture. It also allows ORD to direct questions to the correct subject matter experts (SME) and collect information on hot topics to expand the knowledge base. 
  • The addition of new filters to search for document type, topic, and sort by publication date. 
  • Starting immediately, all users, with the exception of local research administrators and central office staff will be required to categorize their questions into a topic based on the question's content. Questions falling within the realm of research policy topics will be promptly routed to the appropriate SME for resolution. However, some topics lie outside the scope of our designated experts' knowledge. In such cases, users will receive guidance on alternative pathways to finding answers. 
    • More information related to the pre-question screening process can be found in the General User Guide (VA network access only) and during our upcoming office hours. 

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. 




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.”




VAIRRS STUDY TEAM TRACKING

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.

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. 

Office of Research Reviews

In a recent milestone, the ORR successfully piloted a Centralized Information Security Review (CISR) process with the National Cancer Institute and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). As part of this pilot, ORR prepopulated trial-specific Enterprise Research Data Security Plan (ERDSP) templates for select research projects. The prepopulated ERDSP templates were made available to participating NAVIGATE sites through a custom document library in ORR’s public workspace in VAIRRS/IRBNet.

Using the Forms and Templates library functionality in VAIRRS, ORR established a centralized repository for project-specific documents and pertinent Standard Operating Procedures (SOPs) or guidance documents. This repository allowed researchers to easily access the ERDSP needed for their research and to provide only site-specific information, such as document storage location, leading to a more efficient submission and review process.

As ORR celebrates this accomplishment and possibly a new precedent in centralized information security reviews, we look forward to continuing work with NAVIGATE to enhance the established process and assist similar groups in the VA research community who may need centralized information security review.

To request more information about the CISR process or recommendations on additional topics, email the Research Review Team at OISISPSSDCDORRRESEARCHREVIEWTEAM@va.gov.

New Wizards

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.

VAIRRS DATA EVALUATION SURVEY

ORD leadership is looking to assess the field's level of confidence in the completeness and accuracy of the research data within VAIRRS. This survey will also collect pertinent information that will feed into VAIRRS strategy for 2024-2028. The VAIRRS Data Evaluation Survey will serve as the mechanism to collect data from the perspective of each VA research program.

Starting on June 3, 2024, VAIRRS will begin distributing the VAIRRS Data Evaluation Survey via email to research program administrators, Associate Chiefs of Staff (ACOS), and Administrative Officers (AOs). Facilities may have multiple submissions based on the roles at the facility. VAIRRS will also conduct randomized interviews with facility research programs to gather data. If your facility is selected for an interview, the VAIRRS Support Team will reach out to coordinate. Facilities have until July 26, 2024, to submit their survey responses. We appreciate your participation in advance!



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