Frequently Asked Questions
Conflict of Interest (COI):
Where in IRBNet can sites manage financial conflicts of interest (COI) reviews?
The COI review findings may be documented using the sample letter template, "COI Acknowledgment Sample," available for download from the toolkit on the VAIRRS SharePoint portal (VA network access only). The new financial COI IRBNet module is currently in development and will be deployed in late Summer 2022.
CITI & TMS
Does IRBNet link to TMS/CITI?
Yes, IRBNet supports the integration of TMS and CITI, so that records can be automatically created for users who link their IRBNet accounts to TMS or CITI. CITI integration is complete. TMS integration is in progress, expected to be completed by early 2022.
Will IRBNet update the station’s ePROMISE records?
Currently, the system does not integrate with ePROMISE. We hope to integrate VAIRRS with other ORD enterprise systems in the near future.
Can you tell us more about the impetus for the Feasibility, Alignment, and Scientific Review (FASR) checklist?
We were asked to separate the Feasibility and Alignment assessment from the Scientific assessment since many projects come with a scientific review. The form was created because so many of our facilities were not assessing feasibility until the end of the study, if at all. After thousands of dollars of review time conducted by committees, R&D committees were then challenging if the study could be done or altering the study, causing amendments to be filed with other committees, using even more committee time. Ultimately, the perceived non-completion rate, especially investigator-initiated studies, was the impetus. The burden on the research staff and committees to review projects that are not feasible or scientifically invalid is significant and takes time away from viable and scientifically valid studies.
If the project does not meet the definition of research, does the FA or SR evaluation stop?
Yes, the research service is not responsible for projects that do not meet the research definition, unless your facility requires your review. The quality office is responsible for projects that involve quality improvement/assurance or evidence-based practice, etc.
Can the FASR reviewer checklists be completed after submission to sub-committees, or is the expectation that R&D provides this review first and then repeats the evaluation after approval from the other committee?
The review needs to be completed by someone (not necessarily an R&D member, though they likely have the best grasp of the projects happening across the facility) who can assess whether the project can be accomplished in the proposed time frame by the provider submitting it and if it will interfere with other studies happening at the facility. A statement from the investigator’s supervisor stating they have the time to conduct the project and is qualified to conduct the project would go a long way in helping the person reviewing the form. The review is intended to be done before it is assigned to any committee for review to reduce the burden on the committees of studies that are not feasible or scientifically valid.
Is it acceptable if a site considers feasibility and scientific merit, but lacks a formalized Feasibility Alignment and Scientific Review (FA+SR) process?
The use of the Feasibility, Alignment (FA), and Scientific Review (SR) checklists are encouraged but not required if the facility has an established process in place. This process was established to help sites with no existing FA+SR process. FA+SR is designed to determine whether the project has the appropriate resources and expertise to complete the study, whether the nature of the research is appropriate to be conducted at a given institution, and whether the project is sufficiently meritorious to proceed. The goal of FA+SR is to determine these factors at the beginning of the regulatory review process.
Is the burden of FA+SR shifted from the IRB to the R&DC? The workload of the R&DC has increased substantially and seems unsustainable.
FA+SR is an institutional responsibility and does not necessarily fall within the IRB's purview. The goal of FA+SR is not to increase the workload of the R&DC. The VA Electronic Determination Aid (VAEDA) will be available to all facilities in the Fall of 2022. VAEDA is intended to relieve the R&DC and IRB from reviewing projects that are not research, thereby reducing the burden on both committees. The initial FA Review can be conducted by an R&DC member and is intended to keep projects that are not feasible from ever reaching the R&DC. Like the Enterprise Research Data Security Plan (ERDSP), if proposed technology has little to no chance of being acquired or approved within the VA environment, hopefully, the R&DC will not have to review the project. The goal of FA+SR is to determine these factors at the beginning of the regulatory review process.
Forms & Templates
Will smart forms, fillable forms, wizards, and letter templates be made available to the sites transitioning to VA’s instance of IRBNet (VAIRRS)?
ORPP&E, along with a field-based workgroup, has developed a core library of form and letter templates for each of the committee and subcommittee workspaces in VAIRRS. You may preview the core library stored in the VAIRRS Toolkit (VA network access only) on the VAIRRS SharePoint portal. VAIRRS includes two wizards: The Project Cover Sheet and the IRB Information Sheet. The Project Cover Sheet is required for all submissions. The IRB Information Sheet is required for all submissions to the IRB (internal and external). A continuing review form, closure report, and IACUC information sheet will be developed and rolled out throughout 2022. We are also converting the existing MS Word forms to a fillable .pdf format.
Are sites required to use the ORPP&E core library?
The Project Cover Sheet is required for all submissions. The IRB Information Sheet is required for all submissions to the IRB (internal and external). The ORPP&E core library was designed to provide a standard set of forms and letters for all sites. However, IRBNet supports the ability for you to upload your supplemental forms (such as if a particular form or template is required to support state or local regulations) via the Library Manager.
Will each institution have specific templates for its forms?
ORPP&E, along with a field-based workgroup, has developed a core library of form and letter templates for each of the committee and subcommittee workspaces in IRBNet. However, IRBNet supports the ability for you to upload your supplemental forms (such as a particular form or template required to support state or local regulations) via the Library Manager. If a change to an existing form is needed, a formal email request for modification can be sent to the VAIRRS Change Control Board at VAIRRS@va.gov. Notification of the Board’s decision will be sent to the original requestor. For modified forms and newly created forms, the draft forms will be posted to the VAIRRS SharePoint portal in the VAIRRS Toolkit (VA network access only) for a review period. Notification for all new forms, wizards, and letter templates will be included in the monthly VAIRRS Newsletter and Program Updates.
Does ORPP&E have guidance on how each smart form/wizard questions should be answered?
ORPP&E designed the smart forms and wizards to be as straightforward as possible. In most cases, the researchers must answer simple “Yes” or “No” questions. ORPP&E reviews all feedback on the smart forms from the research community. If a question seems to be producing inconsistent answers or is causing confusion among your researchers, please email the project team at VAIRRS@VA.gov. ORPP&E is also developing comprehensive instructional guides for both the Project Cover Sheet wizard and IRB Informational sheet wizards. Once wizards are completed, they will be published on the VAIRRS SharePoint portal (VA network access only) .
Should the OGE Form 450 Alternative VA be submitted through IRBNet?
No, the OGE 450 Alt VA should not be uploaded into IRBNet. ORPP&E has requested that the researcher submit the OGE 450 Alt VA outside of IRBNet. The researcher may attach the findings to their package if the COI review is complete. The new financial COI IRBNet module is currently in development and will be deployed in late Summer 2022.
Are local sites using IRBNet required to maintain hard copies of research records? For FDA-regulated studies?
No, VAIRRS, VA’s enterprise instance of IRBNet, has an ATO (Authority to Operate) to store VA records and is fully compliant with the FDA requirements at 21 CFR Part 11. The research administration office does not need to download the research records created and stored in IRBNet (VAIRRS) into another electronic storage location or hard copy.
Are documents in IRBNet considered an official “record”?
Yes. While IRBNet is a platform, it has an ATO (Authority to Operate) to store official VA records. There is no need for the research administration office to download records created and stored in IRBNet (VAIRRS) into another electronic storage location.
Is there an instruction manual that can be distributed for researchers and/or administrators?
IRBNet is an intuitive, web-based tool that has instruction and help text available at various places throughout the application. A complete library of training energizers for the researchers, committee administrators, and reviewers are available for download from the VAIRRS SharePoint portal (VA network access only) .
Where can newly transitioned sites go for more help once training is complete?
Many resources are available for newly transitioned sites. The VAIRRS “Ask the Mentor” Discussion Board (VA network access only) on the VAIRRS SharePoint portal (VA network access only) is an excellent resource for questions not answered by the FAQs. You may also request a one-on-one mentor by emailing the project team at VAIRRS@VA.gov. Please make sure all committee administrators are included on the VAIRRS Administrators listserv to ensure receipt of monthly training announcements.
Is there a flow chart for continuing review on IRBNet?
Currently, there is no flow chart documenting the continuing review process because each site establishes its own local process. The continuing review process for studies under the oversight of the Central IRB is as follows:
Step 1: The package is submitted/uploaded to IRBNet.
Step 2: The CIRB Administrator gatekeeper reviews the package and then sends it to Central IRB Manager (or whoever is handling the continuing review).
Step 3: It is added to this individuals’ Admin agenda, and she will conduct an administrative review.
Step 4: At this point, they will identify any errors, deficiencies, needed revisions or additions.
Step 5: Next, they will open the package and contact the study team with a list of required revisions.
Step 6: The study team will make necessary revisions.
Step 7: The individual handling the continuing review will forward the submission to panel 1 or 2 for the reviewer and/or the convened board action.
Is the IRB Chair required to sign approval letters at initial or continuing review?
ORD policy does not require that research approval letters be signed. However, there should be some means of ensuring the legitimacy of the letter and the approval date. In cases where an IRB or Privacy Board has approved a waiver of HIPAA authorization, the form must be signed by the IRB or Privacy Board Chair or a designated member of the IRB or Privacy Board.
Is a wet signature required on board approval letters?
No, there is no ORD policy requirement for a wet signature on any document. VHA policy allows for an electronic or digital signature wherever a signature is required. Local policies may restrict you to wet signatures where wet signatures are described in your local policy. Changes to local policies are recommended to accommodate electronic signatures.
Can the certification statements within the Animal Component of Research Protocol (ACORP) be acknowledged with an electronic signature?
Yes, the certification statements in the ACORP may be signed digitally (defined by VA Handbook 6510 as "a specific electronic signature technology that allows the recipient to prove the origin of the document and to protect against forgery") or with a physical ("wet ink") signature - whichever is preferred. What is important to ORD is that the signature is personally applied by the signatory, unique to the signatory, dated, and unambiguously associated with the certification statement on the final approved version of the ACORP. A signature on the IRBNet package does not apply to any particular certification statement, and signatures provided only at the time of initial submission do not document acknowledgment of the contents of the final approved version if the IACUC required any changes before approval. To meet VA requirements, the investigator may digitally sign the ACORP using Adobe Reader and upload the signed ACORP to the package in IRBNet for review. If the IACUC requires modifications before approval, the investigator must also sign the revised version. After the ACORP has been approved with no further modifications, the certification statements on the final approved ACORP (already signed by the investigator) must be signed by the IACUC chair, Attending Veterinarian, and any others whose signatures are required for applicable appendices. The IACUC administrator should publish the approved, signed ACORP as a board document.
Please note that VA now requires the signatures in the ACORP for every protocol documented on the ACORP form (see Guidance Document AR2020-001, https://www.research.va.gov/programs/animal_research/guidance.cfm).
Are coordinators required to sign every package they submit?
Yes. Every package must be signed in IRBNet using the “Sign this Package” feature by the PI or by the submitter on behalf of the PI.
Skype for Business
Our site has installed the “Skype for Business” add-on for Internet Explorer. Can we use this add-on with IRBNet?
There is a known issue with the “Skype for Business” add-on for Internet Explorer that affects users who create rich-text content that includes phone numbers. In IRBNet, this primarily affects administrative users who draft decision letters in the rich-text editor. Microsoft has not yet released an update to address this issue. If possible, we recommend that staff who edit letters disable the add-on or use an alternate browser.
Is there a flow chart of the VAIRRS submission process that can be shared with the IRB, RDC, Safety, IBC, IACUC committee members, and Researchers?
Yes. A high-level flowchart of the intended submission process is available for download from the toolkit on the VAIRRS SharePoint portal (click here) (VA network access only) .
Are wizard forms applicable to animal studies?
The Project Cover Sheet wizard is required at initial submission for all studies, animal studies included. The IRB Information Sheet wizard is not required for animal studies.
Does the IRB Information Sheet need to be filled out for animal research?
No, the IRB Information Sheet wizard is only required for studies submitted to the IRB.
Maintenance of a Package
If a package has been unlocked, how does a committee maintain the integrity of a package?
If a package is incomplete and requires additional documents to be ready for review, it may be unlocked and returned to the study team prior to the committee's review. Once the package has been shared with a reviewer, it should not be unlocked. If the committee determines that modifications are required to secure approval, then the modifications or response materials should be submitted in a new package to preserve the original documents.
Do older studies need to complete the Project Cover Sheet wizard?
Older active studies uploaded when the site enrolled in IRBNet should complete the Project Cover Sheet wizard as soon as possible. The IRB Information Sheet wizards should be completed at the next Continuing Review (CR).
When completing a wizard, what should be done if the package has already been sent along for PO, ISSO, and committee review?
Previously reviewed Projects should complete the Project Cover Sheet or IRB Information Sheet. However, when submitting Wizards - specifically in response to the ORD Data Call - approved studies may disregard the guidance text published at the end of the Wizard.
Is there a process for handling duplicate projects for studies overseen by the CIRB? Can duplicate projects be merged or deleted?
Projects with a CIRB shell and a duplicate local project may be reconciled if there has been no submission using the CIRB shell. Please get in touch with VAIRRS@va.gov for further instructions.
Does the VAIRRS system allow investigators to submit a package directly to a committee?
Currently, the system does not allow a package to be submitted directly to a committee. An administrator should review a package for completion before sending it to a committee.
Can a package be unlocked for a single committee but locked for other committees? Do packages operate independently?
No, if a committee unlocks a package, it is unlocked for all committees.
Once a package has been submitted, is it possible to update package forms and documents?
Packages are automatically locked upon submission. The researcher would only be able to modify documents in a package after submission if a committee unlocks the package. They can, however, always submit revised or updated documents in a new package.
How do you update a study in IRBNet if staff leave the project?
For studies under the oversight of the Central IRB, you can list staff that have left the study in 115 section II. Section II has various areas in the 115a PISC Continuing Review Application and the 115b Local Site Investigator (LSI) Continuing Review Application to list staff that have left the study. For non-Central IRB studies, please follow local guidance for required form updates. All studies must update the personnel section of the Project Cover Sheet wizard to remain consistent with current staffing.
How can I update a Principal Investigator (PI) for a project in IRBNet?
The PI or study team member with full access can change the Principal Investigator in the next package by selecting the Edit button on the Project Overview page. The PI’s name cannot be changed on previously submitted packages. Instructions for updating the PI name are located on the VAIRRS SharePoint portal (VA network access only).
In IRBNet, when a study is renewed, should the Initial Approval Date be changed to the most recent renewal date?
The initial approval date represents the date the project received its first approval from the oversight board. The initial approval date should not be changed or updated when recording renewals.
VAIRRS System Inquiries
Do committees have the same set of keys as IRB Administrators?
The committee tools and administrator tools may differ depending on the user's role and level of access.
What is VAEDA (VA Electronic Determination Aid)?
VAEDA is an automated determination tool available to VAMCs participating in the VAEDA soft-launch.
Is VAEDA an IRBNet update?
No. VAEDA is independent of IRBNet.
Am I allowed to use a non-VA email address as my Recovery Email in IRBNet?
Yes. In fact, ORD recommends that all IRBNet users utilize a non-VA email address as their Recovery Email to help ensure continued seamless access to IRBNet when not logged in to the VA Network. Your Recovery Email is used to receive the multi-factor authentication (MFA) code sent to you when you access IRBNet for the first time from a new device. Since IRBNet generates this code, this code is not VA data, and receiving this code to your non-VA email address does not violate VA policy.
How can I view a researcher's current training?
There are several ways to get this information. The first option is to use the Track Training tool. When searching for a user in the Track Training tool, select "Set Dates as of Today." This will pre-populate your search criteria so that it only looks for current trainings. The second option is to use the "Project Team Tracking" section of the Submission Detail page. This section lists all of the researchers on the project and any accepted training records for types that you have flagged. For example, if a researcher is required to take a given CITI course, then you can flag that course on the Manage Types and Flags page, and any time you open the Project Team Tracking section, any researchers that have current training for that course will have a colored flag next to their name. The third option is to use a Training Insight Report. This will give you all of the training records accepted by your research program, which you can then filter for current training. This last option is primarily helpful for reporting across the entire program, instead of an individual project (such as, if you want to know how many people have taken a given course).
Where do we get the VA Central IRB study number (the 4-digit number)?
The number (two-digit year-sequency number) is assigned by the VA CIRB office and is added to IRBNet once it is assigned. The number is inserted as the "Ref #" next to the submission date on your Submission Manager page.
How does a new staff member gain access to IRBNet?
New staff members must first VAIRRS SharePoint portal, the local IRBNet administrator must send an email to IRBNet Support at firstname.lastname@example.org to request administrator access to the appropriate workspace(s).
Project Cover Sheet
For multi-site studies, to which site should the Project Cover Sheet be submitted?
For studies under the oversight of the VA Central IRB, the Project Cover Sheet should be submitted to the VA Central IRB for the lead site and each local site.
For multi-site studies with a Central IRB shell and a duplicate local project, is the Project Cover Sheet required for both the Central IRB and local versions?
No. We are reconciling the list of active projects to account for studies with two versions in IRBNet. The Project Cover Sheet should be submitted to the Central IRB using the Central IRB shell.
How do I close a project in IRBNet?
Access the appropriate subcommittee(s) and click on the project ID. In "Review Details," select the pencil and paper icon, which will take you to the "Review and Minutes" page. Update the appropriate project status by selecting "Closed" in the drop-down menu. Note, projects need to be closed in all subcommittee/board workspaces, including the intake workspace, in order to fully close the project in IRBNet. Be sure to remove the project expiration date, leaving the field empty, to prevent unwanted expiration notifications in the future. If the selected board action for the closure package is "Tabled without Action," "Withdrawn," or "Forwarded," the Active Projects report will exclude this package when determining the most recent review.
What is the purpose of the Project Cover Sheet (PCS) Wizard?
The Project Cover Sheet Wizard is what drives a majority of the metrics needed for the research enterprise dashboards. The data collected in the Wizard feeds the local and ORD dashboards. The Chief Research and Development Officer (CRADO) currently utilizes the ORD-level dashboard to view research activity at a national level. The facilities participating in the Dashboard Focus Group may access their dashboard to view research activity at their facility. Dashboards for all medical centers will be deployed in May 2022. The ORD dashboard is a decision-making tool that allows ORD to identify gaps in the national research program. Prior to VAIRRS, ORD did not have a central data collection tool that included data on ORD-sponsored, externally funded and locally funded projects. VAIRRS now provides a complete picture of research activity across the VHA research enterprise. Numerous groups within the Central Office are partnering with ORD to use the data provided by VAIRRS to decrease the burden on research offices as it relates to reporting. The end goal is to no longer need to conduct data calls out to the field.
If a researcher submits a Project Cover Sheet Wizard and information is found to be incorrect, can the research team go back to the Wizard and correct the information? How can this be accomplished without having to generate a new Wizard?
Two mechanisms allow you to do so. First, if the Project Cover Sheet Wizard is already submitted and the package is locked, the researcher can clone a previously completed Wizard and jump to the section that needs to be revised. The second scenario is if the package is unlocked, and the researcher was instructed to revise it. There is a pencil icon next to the Wizard on the Designer page for the package to allow them to edit the Wizard for resubmission.
Which study team personnel should be included in the Additional Personnel section of the Project Cover Sheet wizard?
At a minimum, the Principal Investigator, Study Coordinator, and study team members for whom training is tracked in IRBNet, or require access to the electronic health record, should be included in the study team section of the Project Cover Sheet. The personnel information provided in the Project Cover Sheet wizard should be consistent with any local personnel form that is required for the study action.
Within IRBNet, some CIRB studies have an expiration date, but no report due date; some have a report date, but no expiration date; and some have neither of those dates. Can you explain why this is and what it means for each project?
An expiration date indicates that continuing review is required. Reminder notices will go out at 90, 60, and 30 days prior to the expiration date. The continuing review is due into IRBNet 60 days before the expiration date. Report due date only means that an Annual Status Report is due from the PISC Study Team. The Annual Status Report is due 30 days before the due date. No dates would indicate that a local site does not require continuing.
How do we know which studies will require continuing review versus just the annual report?
Your initial approval letter will state whether continuing review is required. Your initial approval letter will note that continuing review is unnecessary if the study is minimal risk, adheres to the 2018 Common Rule, and meets all other criteria. For studies under the oversight of the Central IRB, the approval letter will be specific and provide you with the form number: Form 130 Annual Status Report. Some studies are minimal risk and typically do not require continuing review; however, should the Central IRB reviewer or the Central IRB want to see that study, it will be stated in the initial approval letter and continuing review approval letter if an additional continuing review is needed. This is true even if only for one cycle of continuing review.
Why did ORO decide to suddenly develop the VAIRRS/IRBNet RCO Workspace?
ORD and ORO started discussions in July 2021. The VAIRRS contract modification was awarded in April 2022 and formally announced shortly thereafter. The VA contracted for the RCO module in response to feedback from RCOs that publishing audit results, notifying committees and researchers of audit results, and aggregating the data for the Facility Director Certification report was a burden on RCOs.
Is the use of the VAIRRS/IRBNet RCO Workspace required?
For IRBNet to provide an RCO with the aggregate data to support the FDC Part B, the RCO must record all of their audits for the reporting cycle within IRBNet using the electronic tools. Any mandate requiring the use of IRBNet would come from ORO.
Will the new module create more work for the RCOs?
No. The RCO module is expected to reduce the amount of work required by RCOs to record and share audit results in IRBNet.
What are the benefits of the RCO module?
RCOs will be able to easily and automatically access the electronic records they need, record audit results using the electronic audit tools, and automatically have VA committees and researchers properly notified and provided with access to the audit results. At the end of the 2022-23 reporting cycle, IRBNet will provide RCOs with aggregate data supporting that cycle's Facility Director Certification (Part B) report.
Will RCOs be required to use the new module?
For IRBNet to provide an RCO with the aggregate data, and for the data to be accurate, the RCO must record all of their audits for the reporting cycle within IRBNet using the electronic tools. The oversight committee may request RCO audits be submitted using RCO module. Use of the new module is strongly encouraged by ORO.
Are projects required to be shared with all project team members?
As part of each review process, the subcommittee must ensure that the project has been shared with all project team members. This is important because it affects an RCO's ability to access the complete project record and training information when performing an audit.