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 Have you checked your sites' IRB Information Sheet wizard completion rate recently? As of now, we have reached a 69% 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 September 7, 2023, there are 953 active projects related to COVID-19 research taking place at 81 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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New this year, VAIRRS has established the VAIRRS Enterprise Partnership Award (VEPA) to recognize VA research programs that meet and exceed requirements and have fully transitioned to VAIRRS to meet enterprise standards put in place by the Office of Research and Development (ORD). The VEPA recognizes VA research programs by size (small, medium and large) and will award three programs on an annual basis based on their completion metrics and positive contributions that has enabled the expansion of VAIRRS and ORD mission and priorities.
Stay tuned for our upcoming newsletter to see the winners of this year’s VEPA!
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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, Office (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.”
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In August, VAIRRS University added training materials from the Office of Research Reviews (ORR) in the "Additional Resources" section. Click here to access the webinar recording and slides, which demonstrate how to use the Technical Reference Model (TRM) Global Research Tags and the ORD Global Tags report when searching to identify approved and preferred software for use in VA Research projects.
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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 Are you a VAIRRS super user? 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. We currently have 12 mentor vacancies, and our goal is to fill at least half of the remaining slots in the first wave by December 1, 2023.
Mentor applications can be submitted throughout 2023. You can access the mentor/mentee applications via the VAIRRS Mentor Program SharePoint page.
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As of June 28, 2023, the VA Central IRB has released the first and second phase of new forms which are posted in the VA Central IRB IRBNet Forms and Templates library.
The VA Central IRB will announce the third release of the remaining New Project submission forms on the VA Central IRB Website (VA Central Institutional Review Board (IRB)) and email communications in late September or early October. The release of these remaining forms is pending a concurrent update to the VAIRRS IRB Information Sheet and other new wizards. Please stay tuned.
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.
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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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Starting October 1, 2023, the VAIRRS Support Team will send out an automated email notification regarding the number of expired studies at your facility based upon your facility's data within IRBNet and the VAIRRS Dashboards. The expired projects email notification is intended to serve as a reminder to research administrative staff, principal investigators, investigators and other research stakeholders, regarding projects that have passed the expiration date or are about to expire within the next 30 days. Facility research program leadership and all those who have access to the Field Staff Reporting Dashboard will receive the expired projects email notification. Email notifications will be sent once a quarter. |
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During the May/June and July/August Change Control Board meetings, the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint. The next VAIRRS Change Control Board meeting is scheduled for September 28, 2023.
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CCB Meeting
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Form
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Summary of Changes
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May/June
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3.16L Directors Certification International Research
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New form added to library.
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May/June
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3.17L Directors Certification Pregnant Women
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New Form added to library.
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May/June
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3.18L Directors Certification Children
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New form added to library.
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May/June
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3.18L Directors Support Prisoners
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New form added to library.
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May/June
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2.1 Request for Waiver of HIPAA Authorization
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Removed the following language from Section VI. regarding Central Privacy Board because it does not apply to field sites:
"If the Central Privacy Board Reviewer has a conflict of interest, check the box and return to the Central Privacy Board Administrator."
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May/June
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7.18R Reviewer Checklist Amendment
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Added an additional checkbox option for the following:
"The proposed amendment or modification involves informed consent or conveying new information; the participants who have already consented to participate need to be reconsented or informed."
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May/June
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7.19L IRB Amendment Approval Expedited Convened Letter Template
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Added the following question to fulfill requirements from VHA Directive 1200.05 § 17c :
"If the proposed amendment or modification involves informed consent or conveying new information, do participants who have already consented to participate need to reconsented or informed?"
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May/June
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7.2A Combined ICF and HIPAA Authorization Template
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- Corrected the header "Health Information Portability and Accountability Act (HIPAA)" to "Health Insurance Portability and Accountability Act (HIPAA)"
- Clarified and provided instruction on when a combined ICF/HA can be used. This is the same language provided for our 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 and we are trying to be consistent.
- Updated 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 nay 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”.) This includes language clarifications from VHA Privacy.
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Updated 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, Office (FDA), Office of Human Research Protections (OHRP), the VA Office of Research Oversight (ORO), the Government Accountability Office (GAO; Sponsors; Contractors, Affiliates as appropriate)l the VA Institutional Review Board, and the local VA medical facility Human Research Protections Program.“ This includes language clarifications from VHA Privacy.
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Added the following language to be consistent with the VA Form 10-0493 “Include the following language verbatim depending upon the choice made: While this study is being conducted you (Choose one of the below to complete the sentence):
• Will have access to your research related health records OR,
• Will not have access to your research related health records. This includes language clarifications from VHA Privacy.
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Updated the revocation language from sending the revocation form to the Release of Information Office to “To revoke your authorization, you can ask a member of the research team to give you a form to revoke your authorization in writing. Your written request will be valid when the research team receives it.” Most ROI offices have no idea what to with the revocations and requested to be removed from the process. VHA Privacy approved this change as well.
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Updated paragraph to, “If you revoke this authorization, (insert name of Site Investigator) and his or her research team can continue to use information about you which the research team has relied upon for the research and that was collected before receipt of the revocation.” This includes language clarifications from VHA Privacy.
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July/August
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7.0A Request for Waiver of Documentation of Informed Consent
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Removed signature line from Section V.
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July/August
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7.1A Request for Waiver or Alteration of Informed Consent
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Removed signature line from Section V.
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July/August
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7.12A Request to Transition to the 2018 Revised Common Rule
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Updated the functionality of the PDF version and added a MS word version.
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Locating VA Central IRB Exempt Projects:
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The Field Staff Reporting Dashboard now includes a filter option to allow for searching CIRB Exempt, active projects. The new functionality is available now. Please filter for “VA CIRB (Exempt)” under the filter “Board Type” in your desired page.
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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 Continued
Date: Tuesday, October 10, 2023
Time: 2:00 - 3:00 PM (EST)
Purpose: 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!
*Link will be available shortly.
*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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Lack of guidance for principal investigators (PIs) and study coordinators (SCs) on how to create projects for local site investigators (LSIs), and how to share or transfer a project to an LSI. |
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VAIRRS is developing a navigational guide to walk PIs and SCs through the process of creating, sharing and transferring a project for LSIs based on updated processes from CIRB and within IRBNet. The navigational guide will be highlighted on VAIRRS University once available. |
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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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