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Who can access the VAEDA application? What is the role of local administrators?
VAEDA is designed for use across VA by various stakeholders involved in research determination processes. Project leaders or their designees interact with VAEDA to receive preliminary determinations. Each facility can have one or more administrators who review preliminary determinations and supporting documentation to produce a final determination. Local decisions regarding final determinations are authoritative.
How can facilities register local administrators for VAEDA?
Facilities can register site administrators by submitting a request through the provided link: https://forms.office.com/g/FXT4g6tYVr
What is VAEDA and its’ purpose?
VAEDA stands for the VA Electronic Determination Aid, designed as a decision support tool to provide preliminary determinations for research, quality improvement, program evaluation, and innovation projects. It aims to standardize project classifications and reduce administrative burden while decreasing regulatory risk.
How does VAEDA work?
VAEDA guides project owners through a series of branching, logic-based questions to determine if their project falls under research or non-research categories. It helps route projects for appropriate approvals and provides next steps based on the determination outcome.
What is the role of VAEDA in the overall approval process?
VAEDA provides preliminary determinations that are then submitted to the approving authority (e.g., VAIRRS for research, local process for non-research) to complete the final determination and proceed with the approval process.
What are the benefits of using VAEDA?
VAEDA increases accuracy in preliminary determinations, standardizes questions and information provided, reduces time to determination results, saves resources, consolidates determinations in one platform, and promotes efficiency and access to determinations for all facilities.
Is there a way to jump to a specific section/item using the amend feature in VAEDA?
Yes, you can navigate to different sections/items in VAEDA using the amend feature. Selecting "amend" will prompt you to choose the title, and then you can use the "jump to" button at the bottom of the page to access any previously responded questions.
How does VAEDA contribute to regulatory compliance within the VHA?
VAEDA's standardized approach ensures regulatory compliance by guiding project owners through the necessary steps and requirements, reducing regulatory risks for VA. It helps align VA as a high reliability organization.
What constitutes a multi-site engagement?
Multi-site engagement refers to activities happening at more than one VA facility. The involvement of co-investigators or collaborators from other VAs qualifies as multi-site engagement. Obtaining data from VINCI from across the VHA that will be analyzed at one VA does NOT count as multi-site.
Does multi-site engagement in VAEDA mean that two VA sites are engaged? What if the second VA site is not engaged in human subjects’ research?
The term “multi-site engagement” is not used in VAEDA. VAEDA asks about multi-institutional involvement, meaning more than one institution is involved in the project. This prevents project teams from submitting more than one determination for the same project. The project lead should complete VAEDA and share the preliminary determination with the other sites. If the project is determined to be research at one site, all sites involved in the project are considered involved in research. If the project is determined to be human subjects research, local sites can then decide whether their site is engaged in human subjects research or is conducting research not involving human subjects (e.g., when deidentified data are sent to a facility for analysis).
Can project owners rely solely on VAEDA determinations? Is the determination in VAEDA final or preliminary?
All determinations generated in VAEDA are preliminary. A final determination is still required by a local determination or approving official before projects can proceed.
How does VAEDA reduce the administrative burden if someone on station still needs to conduct a final review?
VAEDA reduces administrative burden primarily for research offices and IRB chairs who no longer need to handle non-research determinations that should not reach their desks. While someone still conducts a final review, the burden is distributed more appropriately.
Is there a document that allows an administrator to know all possible parts of the logic considered in the determination?
Yes, all questions answered during the preliminary determination process and their answers are included in the preliminary determination, providing transparency and clarity to administrators.
For the percent effort question, is that effort of the Project lead?
Yes, the percent effort question is related to the estimated amount of time devoted to the project as a percentage of the project lead's total effort. It is not a mandatory field in the system, though some facilities require it’s completion.
What does the timeline of a study have to do with a research determination?
The timeline of a study is an administrative question to ensure that you are not trying to secure a retrospective approval. Research cannot be approved if the project has already started.
Is there an item in VAEDA asking if the project is funded or supported as research?
No, VAEDA does not consider project funding or support when determining whether a project meets the definition of research under the common rule (38 CFR 16).
What if a person incorrectly receives a non-research determination because they didn't answer the questions correctly?
If someone receives a preliminary determination based on incorrect responses, the error(s) should be detected by the determination or approval official. However, project leads are encouraged to double check their answers before finalizing their determination.
What more needs to be decided at the local level for the final determination if the VAEDA process indicates the project is non-research?
A local review is necessary to ensure that the answers provided in VAEDA match the proposed activity. The local decision-making process verifies alignment between VAEDA responses and submitted details, facilitating accurate determinations. A final determination and approval to start a project are two separate activities, however, they can be completed by the same individual depending on local site policy.
What projects are exempt from using VAEDA?
Local policy and program offices dictate whether VAEDA is used for determinations. Research studies requiring IRB review (such as clinical trials) or involving animals (requiring IACUC review) do not need to go through the VAEDA process as they are clearly research projects.
Is Quality Management also being trained in VAEDA?
While formal training sessions with Quality Management have not yet occurred, we are working towards incorporating VAEDA training for Quality Management in the future.
When will the VAEDA preliminary research determination be required to be uploaded into VAIRRS as part of the research package submission?
There are no current plans to mandate VAEDA research preliminary determinations into VAIRRS, but uploading the document is highly recommended with your project documents to assist in getting to a faster final determination and review. Local policy dictates how determinations are ultimately handled at each facility.
Should there be project documents explaining the project to assist with the final determination and project approval for non-research determinations?
Yes. The project owner must upload supporting documentation in the project review module (for non -research preliminary determinations) to assist with the final determination and project approval.
VAIRRS System Inquiries
Is there a recommended review or determination tool for the approving official to use in VAIRRS?
The VAEDA questionnaire and logic will eventually be translated into a wizard, iVAEDA, to support research determinations within VAIRRS. VAEDA will continue to function outside of VAIRRS for project leads not affiliated with VHA research.