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Thank you to the research office staff and investigator community for your efforts in completing the Project Cover Sheet Wizard for all of your active projects.
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As of May 11, 2022, we have completed 10,821 Project Cover Sheets, accounting for 62% of the 17,044 Active Projects.
Please continue to complete Project Cover Sheets for ALL active projects in IRBNet. If you have questions regarding Project Cover Sheets, reference the VAIRRS FAQs or contact VAIRRS@va.gov.
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The nomination period for the VAIRRS Strategic Advisory Council (VSAC) is now closed. Thank you to all individuals who self-nominated or nominated a colleague. We are currently reviewing the nominations and conducting the selection process. All nominees will receive a follow-up message via email in the coming weeks.
The first VSAC meeting will be held in June 2022.
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RCO Module
The new RCO module is scheduled for deployment in June 2022. The new module has many advanced features, such as providing the ability to easily and instantly access the
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electronic records for audits, record audit results using the electronic audit tools, and automatically have VA committees and researchers properly notified and granted access to audit results. At the end of the 2022-2023 reporting cycle, IRBNet will provide RCOs with aggregate data supporting that cycle's Facility Director Certification (Part B) report.
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COI Module
The new COI module is currently in development. A data call for local COI administrator contact information will be distributed to all research offices in the coming weeks. Please keep an eye out for this request.
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Project Cover Sheet Personnel Tracking Updates
The Project Cover Sheet has been updated to improve study personnel tracking. The
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changes aim to remove the need for R&D committees to track project staff outside of VAIRRS, and to assist sites using or transitioning to Cerner Millennium with their Electronic Health Record (EHR) Research User Roles assignments. Studies will need to update the Project Cover Sheet any time study personnel are added, removed or have a change in their EHR access needs for the project. This new process, used by all facilities, will remove duplicative tracking and help ease future transitions to the Cerner Millennium EHR.
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Project Cover Sheet “Use of EHR” Updates
A new question has been added to the Project Cover Sheet in the “Study Characteristics” section that tracks which research projects will be using the EHR (CPRS or Cerner Millennium) for research purposes. The new question will assist sites transitioning to Cerner Millennium in identifying studies that need to use Cerner applications. If clarification is needed, feel free to reach out to researchehrmhelp@va.gov.
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Field Staff Dashboard
The VAIRRS Field Staff Dashboard is available and ready for use! In order to access the Field Staff Dashboard, you must request access via the Field Staff Dashboard Request Form. You will receive a notification email once your access has been granted.
The Field Staff Dashboard features quantitative and qualitative metrics specific to your facility and available to anyone at your facility, upon request. Click here to access the Field Staff Dashboard.
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Central Research Privacy Board (CRPB) Closure: ORD will close the VA CRPB on May 31, 2022, in compliance with the Memorandum of Understanding (MOU), Section E, Termination Provisions. Formal closure letters will be sent by ORD to each of the nine sites in May 2022. The closure of the CRPB is not associated with the Central Privacy Review pilot program.
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Thanks to those facilities that have already volunteered for the VA Electronic Determination Aid (VAEDA) soft launch. VAEDA is provided to reduce variability in research determination outcomes and save time and resources in your day-to-day processes. We are excited to launch this program to improve the efficiencies of VA Research enterprise operations. If your facility is interested in participating in the soft launch of VAEDA, please email VAEDAsupport@va.gov.
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VA CENTRAL IRB
FAQs
1) Does adding a fillable field to an approved Informed Consent and/or HIPAA
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Authorization require a modification require a modification to be submitted to the Central IRB?
If you are only adding fillable fields to the approved Informed Consent and/or HIPAA Authorization and there are no changes to the content or new fields being added, then you do not need to submit a modification to the Central IRB.
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2) Does an Investigator’s Biosketch/CV need to be signed and dated when submitting to the Central IRB?
The Central IRB is no longer requiring an Investigator’s Biosketch/CV to be signed and dated. However, the Investigator’s Biosketch/CV must be up-to-date and include their current VA appointment.
NOTE: Your local VA Research Administration may have different requirements than the Central IRB. Please keep this in mind throughout your submission process.
Updated VA Central IRB Meeting Schedule
Please visit VA Central Institutional Review Board (IRB) for the all Central IRB scheduled meeting dates in 2022.
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LEARNING CORNER
The Office of Research Protections, Policy, and Education (ORPP&E) is hosting a webinar:
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Topic: VAIRRS Monthly Webinar - IRBNet Basics for Investigators
Date: Tuesday, May 24, 2022
Time: 2:00 - 3:00 PM (EDT)
Purpose: The purpose of the VAIRRS monthly webinar is to provide expert advice, training, demonstration and/or direction to the VA research community regarding the various topics around the VAIRRS transition.
Lead Presenter: Angela Foster
Target Audience: R&D Committee members, IRB members, Research Office Staff, Compliance officers, Research Committee Members, Investigators and study team members
CLICK HERE TO REGISTER!
*We suggest you log on using Google Chrome or Microsoft Edge.
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IRBNet Package Requirements
The list of expectations for all sites is as follows:
For active studies converted at the time of IRBNet enrollment:
- The converted project is shared or transferred to the PI.
- All study actions completed at an internal or external committee are recorded in IRBNet.
- Project status and relevant dates are maintained at the R&DC and each subcommittee.
- The Project Cover Sheet is completed ASAP
- The IRB Information Sheet (if applicable) is completed at the next CR/annual update
For new study submissions received since enrollment:
- The Project Cover Sheet and IRB Information Sheet (if applicable) are completed at study submission
- All study actions completed at an internal or external committee are recorded in IRBNet
- Project status and relevant dates are maintained at the R&DC and each subcommittee
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IRBNet TOPICS
Action: You Spoke, We Listened
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VAIRRS users are not aware of the VAIRRS SharePoint Portal and some users are having trouble navigating the portal. |
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The VAIRRS SharePoint portal is undergoing a facelift! In the coming weeks, the portal will be reorganized to allow quick and easy navigation to access training resources and relevant program materials. All users will be notified once the redesign is complete. |
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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, first 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 to VAIRRS@va.gov. 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 Program Team
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