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 Have you checked your sites' IRB Information Sheet wizard completion rate recently? As of now, we have reached a 68% completion rate. As a reminder, all human research projects must complete the IRB Information Sheet wizard. Projects under the oversight of an affiliate or external IRB are also expected to complete this wizard. Please continue to work with your investigator community to ensure awareness of the IRB Information Sheet requirement. Thank you!
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As of July 18, 2023, there are 421 active projects related to COVID-19 research taking place at 68 VA Medical Centers across the country. The projects submitted to VAIRRS can be easily tracked via our COVID-19 Research Dashboard. The COVID-19 Research Dashboard allows users to search studies by specific topic and/or location.
The COVID-19-related projects submitted to the VAIRRS platform support and advance VA's clinical and research missions, ultimately helping Veterans affected by the disease.
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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.
We will preview the new Investigator and Study Team Tracking wizards and discuss the rollout plan in the next VAIRRS webinar on August 15, 2023. See "Learning Corner" for more information and the registration link.
The Office of Research Reviews (ORR) is also converting the Electronic Research Data Security Plan (ERDSP) into an electronic wizard. More information and training resources will be made available in late summer 2023.
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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. |
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Privacy Officer Guidance
A waiver of written HIPAA Authorization as approved by an Institutional Review Board (IRB) or Privacy Board (PB) or a signed HIPAA Authorization (either a stand-alone VA Form 10-0493 or a combined informed consent form (ICF) with HIPAA Authorization elements, when applicable) meets the HIPAA requirements, but did you know that it does not meet the Privacy Act of 1974 requirements? An agreement or contract is required in addition to the waiver or signed authorization to disclose VA information to a non-VA entity. Check with your local privacy officer (PO) for guidance.
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ORPP&E Standard Form Library |
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The ORPP&E Standard Form Library on VAIRRS SharePoint is a reflection of the forms and templates library on IRBNet and contains documents managed by the VAIRRS Support Team. This library was created to serve as a supplemental repository outside of the IRBNet environment. Some documents within the library are templates and/or pre-populated examples. If you want to reference the clean version of a form, template or letter, please defer to the standard form library on IRBNet.
The library is organized by the following categories based on your role in IRBNet except for the "Change Control Board (CCB) Documents for Review" category, which houses documents that have been updated/changed based on the CCB's decision and will be uploaded to IRBNet.
- Researcher/Administrator
- Committee Members/Reviewers
- CCB Documents to Review
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VAIRRS Change Control Board
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During the May/June Change Control Board the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint.
- 3.16L Directors Certification International Research
- 3.17L Directors Certification Pregnant Women
- 3.18L Directors Certification Children
- 3.81L Directors Support Prisoners
- 2.1 Request for Waiver of HIPAA Authorization
- 7.18R Reviewer Checklist Amendment
- 7.19L IRB Amendment Approval Expedited Convened Letter Template
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VAIRRS University has added a new “Spotlight” feature to highlight the latest program updates. You’ll find links to “What’s New”, as well as the latest VAIRRS webinar and newsletter all in one place.
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.
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The VA Electronic Determination Aid (VAEDA) is available for all VA facilities. You can access VAEDA here.
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VAIRRS Experience:
Back in November of 2019, VAIRRS was implemented at the VA Salt Lake City Healthcare System. While a lot of training was provided, users found it challenging to keep up with the vast amount of information sent their way and found it encouraging to have support from the IRBNet Team and Angela Foster, Program Manager, Enterprise Research Data Systems, Office of Research Protections, Policy, and Education (ORPP&E).
“Spending time with Angela Foster, walking staff through the entire process was very helpful,” says VA Salt Lake City Healthcare System. Speaking in more detail with the staff, an exercise Angela Foster ran using the sandbox where various people in the meeting acted as the PI (principal investigator), committee manager, reviewers, committee members, committee chair, etc., and routed the package through R&DC's (Research & Development Committee) final approval, was foundational to understanding VAIRRS.
“That exercise gave the most situational awareness of how to do things, where the issues were, and create our own local processes that are still under consideration and revision,” says VA Salt Lake City Healthcare System.
To recreate that experience, the VA Salt Lake City Healthcare System started having VAIRRS office hours once a week. The goal was to develop a local checklist to move things through the VAIRRS system including active projects, review process, training, work in progress, packages, project expirations and IRB coversheet wizards.
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VA Central IRB and Upcoming Training Courses/Webinars
Central IRB Forms and Process Updates
The VA Central IRB has released the first and second phases of new forms which are now posted in the VA Central IRB IRBNet Forms and Templates library.
The first phase, "Continuing Review Forms," was released on June 14, 2023, and the second phase, "Post Approval Submission Forms," was released on June 28, 2023.
Prior to using these new forms, please visit the VA Central IRB Website (VA Central Institutional Review Board (IRB) and review the summary that describes all form and process changes that have been made to date. Additionally, you may refer to the ORPP&E Webinar Archive, where the past recordings of the “VA CIRB: Continuing Review Process and Form Changes” and “VAIRRS Monthly Webinar Series: VA Central IRB Updates on New Processes and Forms” may be reviewed. All new "Continuing Review" and "Post Approval" forms must be used by August 14, 2023. On this date, any package submitted with an old version of a form will be returned for the new form to be submitted.
The VA Central IRB will announce the third phase's, "Remaining New Project Forms," release in late July or early August. The release of these remaining forms is pending a concurrent update to the VAIRRS IRB Information Sheet wizard.
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. If there are any questions or if assistance is needed while compiling a submission during this transition time, 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.
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 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 additional mentors to assist users who are seeking to improve their knowledge of VAIRRS. Serving as a VAIRRS mentor is a rewarding (and reimbursable!) experience.
Mentor applications can be submitted throughout 2023. You can access the mentor/mentee applications via the VAIRRS Mentor Program SharePoint page.
Meet our third mentor, Katrina Stumpf!
Katrina Stumpf is the IACUC Chair and Director of Safety and Animal Care Programs at the Central Virginia VA Health Care System. She has worked for VA for 24 years and loves being able to provide a great environment for their research animals. Katrina enjoys teaching and is excited for the opportunity to expand her skills and to connect with peers at other sites. She has been using IRBNet for 3 years.
Outside of her work at VA, Katrina is Vice President of James River Greyhounds, a nonprofit that adopts retired racing greyhounds. She has four retired racing greyhounds and another hound-mix. Katrina also enjoys bird watching and has created a bird sanctuary in her front yard. Additionally, she enjoys traveling to find great food, great wine and new adventures.
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Since FIND Pro Launched on June 13, 2023, we have had over 1,500 logins and 600+ new users. Over 1,225 searches have been performed, with the top search terms being 1200.05, Informed Consent, Repository, 10-9012 and Research.
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 clicking on this link.
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. Further instructions are provided here.
3. If you need help or would like more information:
Office hours: Recurring office hours via Microsoft Teams started this month and are held the second Tuesday and the fourth Wednesday each month. To attend the next session, select the link below:
Wednesday, July 26, 2023, 12:00-12:50 PM (EDT)
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How to export custom reports via VAIRRS Field Staff Reporting Dashboard:
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- From the left navigation menu, select a page within the Dashboard.
- Within the page, select the appropriate criteria using the search bar and various dropdowns.
- Once criteria is selected, hover over a project in the table on the right side of the dashboard until you see a box with ellipses.
- Click the ellipses (three dots) to see "More options".
- Once you click "More Options", select “Export Data” from the drop-down menu.
- A pop-up window will appear where you can select an export option and/or file format.
- Once you select your export option, select "Export" at the bottom of the window to download your report in the format selected.
Look out for more dashboard-specific training resources on VAIRRS University in the upcoming month.
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LEARNING CORNER
ORPP&E is hosting a webinar next month!
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VAIRRS Webinar
Topic: VAIRRS Monthly Webinar: New Wizards
Date: Tuesday, August 15, 2023
Time: 1:00 - 2:00 PM (EST)
Purpose: Join the August feature of the VAIRRS Monthly Webinar Series to learn more about the new VAIRRS wizards. The purpose of the VAIRRS Monthly Webinar Series is to provide expert advice, training, demonstration, and/or direction to the VA research community regarding the various topics around the VA Innovation and Research Review System (VAIRRS).
Lead Presenter: Angela Foster, ORPP&E Program Manager; VAIRRS Support Team
CLICK HERE TO REGISTER!
*We suggest you log on using Google Chrome or Microsoft Edge.
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IRBNet TOPICS
Action: You Spoke, We Listened
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Users having issues with the formatting of fillable PDF forms and templates within the ORPP&E Standard Form Library. |
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VAIRRS will review and improve the quality assurance process for forms and letters, publish both PDF and word versions of forms within the library and improve locked/developer functions in word forms to ensure consistency in forms. |
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IRBNet support is available at govsupport@irbnet.org for technical issues and questions related to IRBNet. For regulatory questions or questions about processes subject to regulatory guidance, visit the ORD FAQs page and use the search tools to find the answer. If you still need help, email VAIRRS@va.gov. The VAIRRS User Group Listserv is also available if you would like to reach out to other users. Email the VAIRRS team to be added to the listserv.
Training resources and the VAIRRS Toolkit are available on the VAIRRS SharePoint portal.
The VAIRRS Change Control Board meets monthly to review requested changes and potential new forms and letter templates. If you wish to submit a change request visit the VAIRRS CCB Request Form. Reminder: It is expected that all VAIRRS sites will use the standard library and supplement with local forms as necessary. The Project Cover Sheet and IRB Information Sheet wizards must be completed at the next study event as soon as possible.
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Thank you,
VAIRRS Support Team
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