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It has officially been one year since the kickoff of the VAIRRS Wizard Completion Campaign! We started the campaign at a 30% completion rate for Project Cover Sheets (PCS), and thanks to your dedicated efforts, we are now at 79%! We ask that you continue to make PCS completion a top priority at your site. Please work with site investigators to ensure wizards are completed for all new submissions and all active projects that have transitioned to IRBNet. Wizards should also be updated whenever there are changes in staffing to remain consistent with study personnel as well as when any changes occur regarding the study's activities.
To date, we have completed 14,674 Project Cover Sheets of the 18,518 active projects.
If you have questions regarding PCS, reference the VAIRRS FAQs or contact VAIRRS@va.gov.
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As of November 1, 2022, there are 966 active projects related to COVID-19 research taking place at 99 VA medical centers. 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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VAIRRS is preparing to launch the VAIRRS University this December! VAIRRS University is an educational initiative designed to optimize VAIRRS-specific training for VA research employees to foster an educated and self-reliant end-user group. VAIRRS University, which can be accessed via the VAIRRS SharePoint, is a revised training library designed to promote an environment of self-education and independence to make it easier for end-users to locate training that meets their needs.
Within the university, end-users can reference curriculum tailored to their user role within VAIRRS (e.g., Researcher/Investigator, Administrator/Submission Coordinator, etc). Users can also reference different categories of training resources, including VAIRRS user guides, IRBNet energizers, training videos and more.
More information and demonstrations of the updated training platform will be shared in the coming months.
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ORD has introduced an optional financial conflict of interest (COI) module in IRBNet that is available for use by VA facilities. The COI module includes a smart form version of the OGE Form 450-alt VA – Research Financial Disclosure of Interest Statement. The IRBNET COI module is optional and has no separate ORD Research Financial Conflict of Interest Directive associated with it. The proposed directive is still in the review process phase, and the publication date will be determined in the coming weeks. VA facilities are not required to use the IRBNet COI module at this time, and VA sites may continue to use their current review processes. VA sites may decide locally if the module supports their existing process and, if so, whether they would like to use the module. COI administrator training will be provided to any site that chooses to adopt the module.
The IRBNet COI module webinar, which aired on October 18, 2022, is available on the ORD Webinar Archive.
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The VA Electronic Determination Aid (VAEDA) is available for all VA facilities. You can access VAEDA here.
Complete the quick, 3-step startup process to begin your first determination:
1) Open the tool in your browser and login with your VA PIV credentials
2) Confirm account details and create profile
3) Start your determination
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VAIRRS is pleased to announce the revamping and launch of the VAIRRS Mentor Program beginning in 2023! The purpose of the VAIRRS Mentor Program is to aid facilities that require advisory support from a subject matter expert within VA research.
Online applications will be available for individuals who would like to be a mentor and sites who would like to be mentees beginning January 2023 with an expected program launch date of April 2023. All mentor and mentee application submissions will be reviewed by the VAIRRS Strategic Advisory Council (VSAC) and ORPP&E leadership.
Please look for additional information in upcoming newsletters.
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VAIRRS Experience: The James J. Peters VAMC, located in the Bronx and serving as one of the largest research programs in VISN 2, covering New York and New Jersey, provides primary and specialty care for Veterans. The VAMC’s research portfolio includes annual spending of about $35M.
The James J. Peters VAMC began using the VAIRRS program in the middle of the pandemic. Thanks to champion Committee Coordinators Trevor Hall and Robert Jordan, the James J. Peters VAMC has been able to train researchers and support staff on how to use the system. The JJPVAMC had over 240 protocols and nearly 500 staffers, so the education demand was high. In addition to group sessions, our champions provided one-on-one training with patience and persistence. Also, one member of the team continually provided liaison support to get answers from experienced users and shared that broadly with all IRBNet users at the JJPVAMC. This played a crucial role in the success of VAIRRS at the Bronx VA.
While there were some initial frustrations, the calm and kind approach of our committee team made the transition happen and the researchers and administrators have discovered many benefits of the program and learned many lessons throughout the process. For example, the pre-programed reminder function reduces the amount of emails that the committee coordinators have to send and allows the R&D administrative staff to tell investigators when work is due. Also, the researchers strongly benefit from storing all documents in one place so that new staff members have a one-stop shop to learn about the protocols.
Congratulations to Trevor and Robert at the James J. Peters VAMC and many thanks for your support!
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VA CENTRAL IRB
VA Central IRB Forms Update
The following forms have been updated and will be available in the IRBNet Forms and Templates Library on November 14, 2022:
- Combined Informed Consent and HIPAA Authorization
- Informed Consent Form
- 105 Request for Exemption
- 116 Amendment Request Form
Please ensure that you begin using these new forms for your next Central IRB submission. Beginning Monday, January 2, 2023, any package that is received with an outdated form will be returned with a request for the current form to be completed and uploaded.
REMINDER: The VA Central IRB has removed investigator signature lines from all submission forms. Adding a signature line to a VA Central IRB form is an unauthorized alternation to approved documents. If a submission form is received with signature lines added by the investigator, the submission will be returned for correction.
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LEARNING CORNER
The Office of Research Protections, Policy, and Education (ORPP&E) is hosting a webinar next week!
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VAIRRS Webinar
Topic: VAIRRS Ambassador Highlight: VA Greater Los Angeles Healthcare System
Date: Tuesday, November 15, 2022
Time: 2:00 - 3:00 PM (EST)
Purpose: Join the VAIRRS November webinar to learn about the September Ambassador, VA Greater Los Angeles Healthcare System, their experience with VAIRRS and tips for the field
Lead Presenters: Cody Knight, IRBNet/MedRIS System Admin & Quantitative Core Team, VA Greater Los Angeles Healthcare System
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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When should the Project Cover Sheet be updated? |
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The Project Cover Sheet (PCS) Additional Project Personnel section must be consistent with local requirements and must be kept up to date with project amendments. As Electronic Health Record (EHR) access needs change, the PCS Additional Project Personnel section must be updated to ensure continuation of appropriate EHR access. If a study team member change does not require an amendment, the Additional Project Personnel section should still be updated to reflect the study team member change and submitted to your local research administration in IRBNet. PCS updates for study team member changes that do not require an amendment must not include changes to study details (i.e. study characteristics), as additional changes may require an amendment and oversight committee/subcommittee review. You must follow the guidance of the oversight committee and/or subcommittee(s) for reporting changes in personnel that do not require an amendment.
Please note, all study team members should be included in the PCS Additional Project Personnel section and shared on the IRBNet project to ensure training can be tracked in IRBNet.
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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. Please submit your suggestions through the VAIRRS SharePoint CCB Requests link (click here). 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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VAIRRS December Webinar
- 2023 Outlook (News VAIRRS Mentor and Training Program)
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Happy Holidays!
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Thank you,
VAIRRS Support Team
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