Research Grant Submission Process
Generally, VBRI will need to review all grants prior to submissions and receive the completed grants submission form. For projects that require services or subcontracts with other organizations, please submit the materials to VBRI no less than three (3) weeks or 15 business days prior to submission deadline. Shorter times may be acceptable if no other organizations are involved.
For investigator-initiated projects with corporate sponsors, a formal agreement is usually required by the sponsor prior to release of funding. These agreements will be reviewed and negotiated by VBRI. All such agreements must be signed by VBRI. Investigators cannot enter into agreements with sponsors that bind VBRI or VANJHCS in any way. Since negotiating agreements with corporate sponsors may be a lengthy process, please advise VBRI as soon as possible.
Clinical Studies
For clinical studies sponsored by pharmaceutical companies, the investigator should advise VBRI as soon as the determination to participate is made. Sponsor contact information including name, email, and phone number will be needed. VBRI will work with Regional Counsel to process the Clinical Research and Development Agreements.
VBRI will also assist with budget review and finalization including any requirement for human subject review costs or the Facility Human Protections Program fees.
Clinical studies that are investigator-initiated will follow the grants process.
The investigator should ensure that all regulatory and compliance issues are addressed, including possible requirements for an FDA Investigational New Drug application.
Post Award
For all research studies, projects cannot be signed, initiated, or have any funds expended prior to VA R&D Committee approval. R&D Committee approval will not be given until committee and all subcommittee reviews and approvals have been received. This may take up to eight (8) weeks or more if Human Subjects Committee approval is required.
In order to avoid a significant delay in study start up, the approval process should begin as soon as notification is received by PI and/or VBRI that a grant or project will be funded.
For pharmaceutical studies, generally the research agreement is negotiated at the same time that the project is being reviewed for IRB approval, so that the project will not be delayed. If any other subcommittee approvals are required, they will need to be completed prior to R&D Committee approval.
The following are the relevant committees for approval of research projects as applicable:
- R&D Committee
- IRB Subcommittee
- Safety Biohazard Committee
- Institutional Animal Care and Use Committee (IACUC)
Once a study has received all required approvals and funding has been received, an VBRI account will be opened. The account number will reflect the VBRI number assigned and promise number issued by R&D after R&D Committee approval.
Funds may be expended from the project account according to the study budget and all relevant guidelines of the sponsor and VBRI policy. Financial reports will be provided monthly to investigators for each project or separate fund.
For all studies utilizing VANJHCS clinical resources that are considered over and above the standard care required for normal patient care, the VANJHCS must be reimbursed. The completed clinical impact form should accurately reflect the resources used, whether for standard care or research only. VBRI will review projects at least annually to verify that bills of collection have been received for these services. If not, staff will follow up with the appropriate services.
When required VBRI will send all required financial reports to sponsors. The principal investigator will be responsible for any scientific progress reports.
Study Closeout
A study should not be closed in VBRI prematurely and generally not until it is removed from the R&D list of approved projects. For grants requiring final reports to sponsor, the fund will not be closed until submission of the final report and its acceptance by the grantor. Study completion occurs when all study research activities have been completed, the study is closed with the relevant VANJHCS research committees, and the grant has been closed out with the sponsor.
Most granting agencies will require return of all unencumbered or unexpended grant funds. However, requests for no cost extensions are usually allowed if appropriate scientific rationale is provided. This allows an extension of the grant period and continued use of the project funds.
If residual funds remain after completion of the project, all expenses have been paid, and there is no requirement by the sponsor to return unexpended funds, these monies may be transferred to a general research account (“0”) to be used by the project Investigator for general research and education expenditures for a 12 month “bridge” period. After the 12th month following post-study closure, the unused residual funds will be automatically transferred into the VBRI general support fund to benefit VA research and education at VANJNCS. VBRI Principal Investigators and associated VA staff can make requests to the VBRI Board for use of general support funds to cover the costs of research or education activities of importance to VANJHCS. For VA approved research projects all expenditures must be consistent with VBRI policies.