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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.
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.
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 [email protected]. 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 [email protected]. 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.
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 [email protected]. Please make sure all committee administrators are included on the VAIRRS Administrators listserv to ensure receipt of monthly training announcements.
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.
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.
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 [email protected] 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 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.
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).
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.
Which study team personnel should be included in the Additional Personnel section of the Project Cover Sheet wizard?
At a minimum, the Principal Investigator and Study Coordinator 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.
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.