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As we kick off 2023, the original Project Cover Sheet (PCS) wizard completion campaign is now transitioning its focus to make progress on the IRB Information Sheet wizard. Currently, only 55% of the active human research projects have completed an IRB Information Sheet, and we are striving for 100%! As a reminder, all human research projects must complete this wizard. The projects under the oversight of an affiliate or external IRB are also expected to complete the IRB Information Sheet wizard, even though it is just a few essential questions.
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As of January 17, 2023, we have reached an 80% completion rate. To date, out of 19,543 active projects, 15,568 Project Cover Sheets have been completed in IRBNet. We thank everyone for their dedication to this effort.
If you have questions regarding PCS, reference the VAIRRS FAQs or contact VAIRRS@va.gov.
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As of January 17, 2023, there are 949 active projects related to COVID-19 research taking place at 83 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 VAIRRS team is excited to present VAIRRS University, a revised training library designed to promote self-education and independent learning. This platform will officially launch next week, on January 24, 2023, allowing VA research employees to easily locate and access VAIRRS-specific training resources.
Want to learn more about VAIRRS University? Join the VAIRRS webinar on Tuesday, January 24th as we officially launch this new resource! Scroll down for details about the webinar and where to register.
Questions about VAIRRS University? Please contact the VAIRRS Support Team at VAIRRS@va.gov.
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Online applications are open for sites that would like to serve as a mentor or be a mentee!
Apply to be a Mentee
Apply to be a Mentor
VAIRRS mentors will be expected to:
- Conduct mentoring and assistive virtual/phone sessions with research programs.
- Assist in reviewing current and planned resources to manage and update VAIRRS/IRBNet workspaces (i.e. research administration).
- Provide feedback to the Office of Research Protections, Policy, and Education (ORPP&E) leadership on issues impacting the field research administration.
- Work with research programs to develop plans for reviewing the efficiency and effectiveness of processes within their program.
- Assist in developing systems to effectively manage risks in research programs.
All mentor and mentee application submissions will be reviewed and finalized by ORPP&E leadership. Mentors and mentees will be selected and paired in the next few months, with an expected launch date of April 2023. You can also access the mentor/mentee applications via the VAIRRS Mentor Program SharePoint site.
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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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Background:
In October 2021, the VAIRRS Site Support program was established to assist sites with administrative tasks to ensure a successful and efficient adoption of IRBNet. The pilot cohort of sites selected (Cohort 1) requested support from VAIRRS due to the administrative hurdles they experienced as they implemented IRBNet at their respective research programs. Over the last year, each site worked with a member of the VAIRRS Support Team to fill the gap in their administrative processes, aid in validating projects and increase their PCS completion rates. Site support for Cohort 1 has concluded and the sites have graduated, successfully sustaining their administrative processes. Cohort 1 facilities are excited to share their experiences, challenges and successes throughout the IRBNet implementation process and their experience with the VAIRRS Site Support program.
Due to the success of this program, VAIRRS will continue to offer administrative support to the field and have already identified candidates for Cohort 2. If you are interested in learning more about the Site Support program, contact the VAIRRS Support Team at VAIRRS@va.gov.
VAIRRS Experience:
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Jennifer Moreno Department of Veterans Affairs Medical Center| VA San Diego Healthcare System: San Diego VA Medical Center (VAMC) started the Site Support program with a PCS completion rate of less than 5%. Throughout 2022, site administrators were able to submit more than 90% of Project Cover Sheets to IRBNet and validate them. Using their current progress as a starting point, they will be able to stay above the 80% PCS completion requirement and maintain up-to-date board actions in IRBNet moving forward.
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Palo Alto VA Medical Center: Palo Alto VAMC was tasked with transferring PCS information for about 600 active projects into IRBNet. Site Support provided feedback on how to best accomplish this monumental task and assisted with technical difficulties on the IRBNet site. To date, Palo Alto VAMC has reached a 99% PCS completion rate.
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San Francisco VA Medical Center: San Francisco VAMC’s IRBNet team was innovative and focused, making site support effective and efficient. The systems they have implemented for submitting and validating Project Cover Sheets will continue to be useful, and their major time and effort commitments have paid off, with the SFVAMC reaching a 100% PCS completion rate.
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Portland VA Medical Center: The Portland VAMC spent the last year working with researchers to encourage PCS submissions. With their help, Site Support was able to provide support validating Project Cover Sheets, allowing for site staff to maintain their normal workload and make progress, reflected by their 100% PCS completion rate.
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IRBNet Data Entry
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What should be entered into IRBNet?
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Who should enter data?
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When should data be entered?
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Why does this data need to be entered?
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Project Cover Sheet
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Principal Investigator (PI)
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- Initial application
- Changes or updates to study that result in a change to previous response
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VAIRRS dashboards provide a detailed overview of the research enterprise. To accurately reflect activity at your site, all actions (including amendments, CRs, reports, etc.) should be entered into IRBNet.
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IRB Information Sheet
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PI
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- Initial application for all studies under the oversight of a VA or non-VA IRB
- Changes or updates to a study that result in a change to the previous response
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Initial and subsequent study actions (CR, Amendments, Report, etc.)
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Committee Administrator
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- All committee and subcommittee actions should be recorded in IRBNet as a board action
- Board actions for studies under the oversight of a non-VA IRB must also be recorded in IRBNet
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LEARNING CORNER
ORPP&E is hosting a webinar next week!
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VAIRRS Webinar
Topic: VAIRRS University Walk-Through
Date: Tuesday, January 24, 2023
Time: 2:00 - 3:00 PM (EST)
Purpose: Join the VAIRRS January webinar to learn more about VAIRRS University, a revised training library designed to promote self-education and independent learning. During this webinar, we will provide a thorough walk-through of the library and there will be time for live Q&A following the presentation.
Lead Presenters: The 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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Committee administrators did not have the capability to add RCO audits to a committee agenda. |
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IRBNet deployed a new function in December 2022 that provides designated committee administrators the capability of adding an RCO audit directly to the committee agenda and track the committee’s follow-up action. Each site was contacted to provide the name(s) of the designated administrator(s) who should have access to this function. Please contact VAIRRS@va.gov if your site is using the RCO module and did not receive the notification. |
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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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Thank you,
VAIRRS Support Team
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