Did You Know?

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.

If you would like to learn more about the new wizards, the recording of the VAIRRS monthly webinar: "New Wizards" is available.

The auto-generated notifications can be customized for your site. Please contact IRBNet Support at govsupport@irbnet.org for more information. 

Recusals can be noted on the Reviews and Minutes page. Under the Voting section, you can add or remove recused committee members, and the recused members will be recorded in the minutes.

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.

CCB Meeting	Form	Summary of Changes
May/June	3.16L Directors Certification International Research	New form added to library.
May/June	3.17L Directors Certification Pregnant Women	New Form added to library.
May/June	3.18L Directors Certification Children	New form added to library.
May/June	3.18L Directors Support Prisoners	New form added to library.
May/June	2.1 Request for Waiver of HIPAA Authorization	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."
May/June	7.18R Reviewer Checklist Amendment	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."
May/June	7.19L IRB Amendment Approval Expedited Convened Letter Template	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?"
May/June	7.2A Combined ICF and HIPAA Authorization Template	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. 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. 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. 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. 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.
July/August	7.0A Request for Waiver of Documentation of Informed Consent	Removed signature line from Section V.
July/August	7.1A Request for Waiver or Alteration of Informed Consent	Removed signature line from Section V.
July/August	7.12A Request to Transition to the 2018 Revised Common Rule	Updated the functionality of the PDF version and added a MS word version.

 

The VAIRRS Strategic Advisory Council (VSAC) recently met to review current personnel tracking processes. The VSAC determined personnel tracking should occur separately from project coversheet tracking. This will provide a more efficient means of updating study personnel and associated training requirements. The VAIRRS team is working on a draft personnel tracking form. We will provide further updates as development progresses.

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.

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.

In August, VAIRRS University added training materials from the Office of Research Reviews (ORR) in the "Additional Resources" section. 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, are available at https://tinyurl.com/57548v3n (VA network access only).

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.

Click below to watch tutorials on how to create and submit COI disclosures within VAIRRS:

• COI Step 1 - Creating COI Disclosure and Responding to an Unlocked COI Package – For anyone who needs to create a COI disclosure or link COI disclosures to an unlocked COI package 
• COI Step 2 - Submitting COI Disclosures – For the person who submits all COI disclosures for a project 

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 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.

We are working through your data validation responses and expect to follow up this month. In most cases, we will reach out to each site to either confirm your updates or reconcile projects. If you have not already reviewed and validated your multi-site data and updated/corrected expired studies, please do so as soon as possible and notify the VAIRRS Support Team at VAIRRS@va.gov once validation is complete.

When assigning a package for ISSO (information system security officer) or PO (privacy officer) review in the research administration or R&DC (Research & Development Committee) workspaces be sure to select the appropriate reviewer designation from the drop-down list. The ISSO and PO reviewer designations are very helpful when tracking reviewer activity.

Did you miss this month’s VAIRRS webinar, “How to Properly Utilize the Research Admin Workspace in IRBNet”? If so, you are encouraged to review the webinar recording and available training resources. A summary of the activities discussed at the webinar are highlighted in the table to the left.

FIND Pro Launched on June 13, 2023.

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 going to https://tinyurl.com/mruyyfez(VA network access only).
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. Please see https://tinyurl.com/u6sc24tf(VA network access only) for further instructions.
3. If you need help or would like more information:
   • Read the full 8-pageuser guide available at https://tinyurl.com/3j7nbj3a (VA network access only).
   • View the webinar-based training video and/or transcript.
   • Email the FIND Pro support team.

Office hours: Recurring office hours via Microsoft Teams started July 2023 and are held the second Tuesday and the fourth Wednesday each month. To attend the next sessions, select the links below:

Tuesday, September 12, 2023, 3:00-3:50 PM (EDT)

Wednesday, September 27, 2023, 12:00-12:50 PM (EDT)

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.”

During the July/August Change Control Board meeting the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint.

• 7.0A Request for Waiver of Documentation of Informed Consent
• 7.1A Request for Waiver or Alteration of Informed Consent
• 7.12A Request to Transition to the 2018 Revised Common Rule (updated the functionality of the PDF version and added a MS word version)

Questions about the R&D website? Email the Web Team

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