Did You Know?

The revised Project Cover Sheet (PCS) wizard is available in the IRBNet sandbox the week of December 11. The updated wizard outline (VA network access only) is posted on the VAIRRS SharePoint portal under the ORPP&E Standard Form Library menu option. The VA Project Lead/Principal Investigator and Additional Project Personnel sections moved to the Study Team Tracking wizard. The IRB of Record Type will appear for all studies that select "Data and/or biospecimens from living human individuals." On the PCS PDF both the "Funding Source Code" and the "Funding Source Code - Other" response will now appear.

Study teams will not be required to update previous PCS submissions unless there has been a change to the study.

⇪

---

⇪

---

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 VAIRRS March CCB meeting, the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint. Additionally, STT and IRB Information Sheet Wizard changes submitted between September 2023 and February 2024 have been implemented and the updated Wizards are now available within IRBNet. 

March CCB Meeting Updates

FORM/LETTER/WIZARD	SUMMARY OF CHANGES
6.1A SRSS 10-0398	The checkboxes under Section 1 were re-positioned so they now appropriately align to their corresponding listed item.

ACTION REQUESTED

We need your help in reviewing suggested changes to the following forms/letters. Please use the link(s) in the table below to review the proposed changes and send your feedback to the VAIRRS Support Team inbox at VAIRRS@va.gov. 

FORM/LETTER/WIZARD	Proposed Change(s)
3.3R RDC Initial Review Checklist	We received a request to add the following prompt to section 1, subsection D (i.e., Medical Center Director Approval and Certifications) within the 3.3R RDC Initial Review Checklist – "Please determine if staff indicated they received outside compensation for VA research in the Study Team Tracking Wizard and, if so, whether the Director or Chief of Staff (following proper delegation) approved the waiver for outside compensation."
4.1L IBC Initial Approval Letter 4.2L IBC 3 Year Approval Letter	We received a request to add the following statement to item no. 3 within both the 4.1L and 4.2L (i.e., replacing the existing no. 3, which will then become item no. 4) – "procedures at the BSL [x] level have been approved for this protocol."

⇪

---

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.

Reminder: New Project Submission Forms were the latest forms to be revised and were released on October 25, 2023. All New Project Submission Forms must be used as of January 2, 2024. Prior to using these new forms, please read the Summary of Changes – CIRB New Project Forms for a detailed list of forms and process changes. For additional information regarding these changes, you may also refer to the VAIRRS webinar from October 24, 2023, titled “CIRB Forms and Process Updates.” 

⇪

---

VAIRRS has added a new Project Closure and Withdrawal User Guide to assist administrators/submission coordinators in performing researcher-initiated closures, administrative closures, and withdrawing an erroneous packages. Users can access the new guide within VAIRRS University by selecting the "Administrator/Submission Coordinator" user role or navigating to the "VAIRRS User Guides" training material category. 

To learn more about VAIRRS University, watch the recording of the VAIRRS University walk-through webinar, led by VAIRRS experts.

For questions about VAIRRS University, 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 

⇪

---

The VAIRRS Mentor Program currently has five team members from various roles across VA providing mentorship, with the ability to support more mentees.

If you are interested in getting help from a fellow VAIRRS user, access the mentee application via the VAIRRS Mentor Program SharePoint page (VA network access only). Applications are accepted on an ongoing basis throughout the year.

⇪

---

The VAIRRS Support Team is expanding the "Expired Projects Email Notification" email to include Project Status and IRB Project Risk Level discrepancies. Expect the new "Data Integrity" email format to launch in mid-June.

⇪

---

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.

⇪

---

The ORD Focused Inquiry Navigation Database (FINDPro) (VA network access only) tool helps users find information regarding ORD policy related to human, animal, and laboratory research protections. The latest FINDPro updates include: 

• The removal of the "ASK ORD" button from the launch page. This allows users to search for information before asking a question, resulting in faster data capture. It also allows ORD to direct questions to the correct subject matter experts (SME) and collect information on hot topics to expand the knowledge base. 
• The addition of new filters to search for document type, topic, and sort by publication date. 
• Starting immediately, all users, with the exception of local research administrators and central office staff will be required to categorize their questions into a topic based on the question's content. Questions falling within the realm of research policy topics will be promptly routed to the appropriate SME for resolution. However, some topics lie outside the scope of our designated experts' knowledge. In such cases, users will receive guidance on alternative pathways to finding answers. 
• More information related to the pre-question screening process can be found in the General User Guide (VA network access only) and during our upcoming office hours. 

Please note: The ePROS webpage is also undergoing changes and the URLs will soon be changing from ORPP&E to ePROS. In addition, some content will be reorganized to reflect the new structure of the enterprise transformation. When this happens, please resave your bookmarks. Sorry for the inconvenience. 

⇪

---

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 (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.”

⇪

---

As of April 10, 2024, study teams who previously completed an STT Wizard will be required to re-enter the first and last names of all "Additional Personnel" the next time they revise the STT Wizard.

Note, this is a one-time occurrence that will prompt users to revise their STT Wizard the first time they return to their existing STT Wizard following this update.

For any study team that completed the STT Wizard before the Wizard update on the evening of April 10, 2024. When you open the "Additional Project Personnel" page, all names of previously entered personnel on this page will be blank. However, the rest of each person's entry is still completed (contact information, duties, etc.). To know which person's name to fill in the two new fields, scroll down to the "VA email" field, which should identify the correct name. Another option would be to download the previously submitted STT Wizard from Designer and use it to re-enter the names of the additional personnel.

⇪

Principal Investigator's (PI) concerned with sharing their or their team’s outside compensation with the rest of the team or the R&D committee can now use an alternative reporting solution, provided below.

Short-term workaround for existing projects:

1. PIs may email (or some other method outside of VAIRRS) outside compensation information to ACOS or a designee within the research office
2. ACOS can obtain approval from AO
3. Committee Administrator may create a ‘Special Events’ package in the IRBNet R&DC workspace
4. Committee Administrators can upload an approval memo as a Board Document and publish it as internal only

Rationale:

The R&DC is not required to review outside salaries for existing projects, therefore the submission of information can take place outside of VAIRRS. The workaround meets the 

requirement for posting the approval memo to the project file, and the only individuals with access to the salary information are the PI who submits, the ACOS, and the Authorizing Official. The R&DC members with access to the project will also have access to the internally published memo.  If this is a concern, the Committee Administrator can remove all committee member access or just provide access to the Chair. 

⇪

Be on the lookout for the upcoming bulletin: "ORR Published Knowledge Base Articles in ServiceNow." The bulletin lists all the Knowledge Base Articles (KBA) focused on information security in research. 

Research KBAs can be found on ServiceNow here.

As always, ORR can provide assistance on this, and other topics related to Enterprise Research Data Security Plans. Assistance requests or additional topics of interest can be sent to OISISPSSDCDORRRESEARCHREVIEWTEAM@va.gov.

⇪

VAIRRS, in joint effort between the VAIRRS Strategic Advisory Council (VSAC) and the VAIRRS Change Control Board (CCB), is developing a Continuing Review Wizard and Administrative Checklist Wizard. The Administrative Checklist Wizard aims to collect board-approved data elements. The Continuing Review Wizard will mimic the existing 7.13A Continuing Review Application. We will continue to provide updates as we progress through the development process.

⇪

The Office of Research & Development (ORD) leadership is looking to assess the field's level of confidence in the completeness and accuracy of the research data in VAIRRS. This survey will also collect pertinent information that will feed into VAIRRS strategy for 2024 – 2028. The VAIRRS Data Evaluation Survey will serve as the mechanism to collect that data from the perspective of each VA research program. 

Starting May 2024, the VAIRRS Support Team will begin distributing the VAIRRS Data Evaluation Survey via email to research program administrators. More information will be provided in the upcoming newsletters and program updates.

⇪

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

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.