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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.

 


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