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Office of Research & Development

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Frequently Asked Questions

If you have additional questions, please contact us at VAIRRS@va.gov.

Question: Will smart forms, fillable forms, and letter templates be made available to the sites that transition to VA’s instance of IRBNet?

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 all be developed within the coming months.  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 on the VAIRRS SharePoint portal.

Question: 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 own supplemental forms (such as if a particular form or template is required to support state or local regulations) via the Library Manager.

Question: Will IRBNet update the station’s ePROMISE records?

Currently the system does not integrate with ePROMISE.  We hope to integrate VAIRSS with other ORD enterprise systems in the near future.

Question: 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 full library of training energizers for the researchers, committee administrators and reviewers are available for download from the VAIRRS SharePoint portal.

Question: Will each institution have their own specific templates for their 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 own supplemental forms (such as if a particular form or template is required to support state or local regulations) via the Library Manager.

Question: Does ORPP&E have guidance on how each of the smart form questions should be answered?

ORPP&E designed the smart forms to be as straightforward as possible. In most cases, the researchers only have to 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.

Question: 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.

Question: 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. TMS Integration is not yet available.  

Question: Should the OGE Form 450 Alternative VA be submitted through IRBNet?

No, the OGE 450 Alt VA should not be uploaded into IRBNet. ORPPE has requested that the researcher submit the OGE 450 Alt VA outside of IRBNet. If the COI review is complete, the researcher may attach the findings to their package.

Question: 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 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 of investigator-initiated studies, was the impetus.   The burden on the research staff and committees for review of projects that are not feasible or scientifically invalid are large and take time away from studies that are feasible and scientifically valid.

Question: 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 definition of research, unless your facility is requiring your review.  The quality office is responsible for projects that involve quality improvement/assurance or evidence-based practice, etc.

Question: 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 repeat the eval after approval from the other committee?

The review needs to be completed by someone (not necessarily an R&D members, 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 he/she has 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 as to reduce burden on the committees of studies that are not feasible or scientifically valid.

Question: What process do you use in IRBNet for managing financial Conflict of Interest review? We currently collect FCOI forms (outside the system) from investigators (PI, co-I) for each study at initial study submission, continuing review, or if there is a change in their information. We’re not sure the best way to document/track in IRBNet that COI forms are on file and have been reviewed.

The COI review findings may be documented using the sample letter template available for download from the toolkit on the VAIRRS SharePoint portal.

Question: 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.

Question: Where can newly transitioned sites go for more help once training is complete?

A number of resources are available for newly transitioned sites.  The VAIRRS ‘Ask the Mentor’ Discussion Board on the VAIRRS SharePoint portal is a great 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.

Question: Is the IRB Chair required to sign approval letters at initial or continuing review?

ORD policy does not require that research approval letters are signed, however there should be some means of ensuring the legitimacy of the letter as well as 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.

Question: 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 where 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.

Question: Are the local sites that are 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 in hard copy. 

Question: Are documents in IRBNet considered an official “record”?

Yes.  While IRBNet itself 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.

Question: 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 be 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 clearly apply to any particular certification statement, and signatures provided only at the time of initial submission do not document acknowledgement of the contents of the final approved version, if any changes were required by the IACUC 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 granting 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 then 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).



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