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RESEARCH ACTIVITY CYCLE

CRADA | Post Award | VA Clinicial Cost Reimbursement | Study Closeout

 

GRANT SUBMISSION POLICY

 

Proposals with 50% or more of the research being conducted in VA Puget Sound Health Care System (VAPSHCS) space must be submitted through SIBCR. Proposed grants are discussed with SIBCR. A draft budget and, if needed, an informal list of resources are reviewed. Appropriate subawards to either SIBCR or the University of Washington (UW) are also determined at the pre-proposal stage. Exceptions to this rule may be made only with mutual agreement of SIBCR and UW at the time of the proposal. UW will submit all proposals for non-VA training grants and NIH K and T awards.

 

SIBCR reviews all grants prior to submission and proposals must be submitted by an SIBCR authorized signing official. SIBCR requires final drafts of all documents five business days prior to the sponsor deadline and a completed proposal at least two full business days prior to the deadline. Proposals that involve collaboration or goods and services from outside organizations must be reviewed at least forty-five business days prior to the sponsor due date to allow sufficient time for review and approval.

 

The below information is a synopsis of some of the important steps in the research activity cycle. More detail on applying for and managing extramural grant funding from outside sponsors such as federal agencies, voluntary health organizations, other nonprofits and corporate sponsors can be found in the Sponsored Programs section. The website provides detailed information on deadlines and forms. It includes topics such as proposal preparation, R&D committee and subcommittee approvals, regulatory compliance, award monitoring, reporting and award closeout requirements. 

 

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

 

A CRADA is the principal mechanism used by federal labs to engage in collaborative efforts with industry partners to achieve goals of technology transfer. It is intended to be a flexible mechanism that can be adapted to different types of collaborative efforts between federal and non-federal organizations and that can be implemented with relative speed and ease. As a technology transfer mechanism, the CRADA is an extremely useful tool in moving federally funded R&D into the private sector.

 

Like for all other government agencies, CRADAs are utilized by VA research facilities. CRADAs establish the terms of sponsored collaborative research. They are specifically designed to protect the parties' prior inventions while allowing the government and private sector research partner(s) to negotiate management of any new discovery or intellectual property that may result from the collaboration.

 

CRADAs are governed by Title 15 Commerce and Trade, Chapter 63, Technology Innovation, Section 3710a Cooperative Research and Development Agreements and are supported by the full weight of the Federal Technology Transfer Act (FTTA).

 

CRADAs are used for both clinical and non-clinical studies, whether industry sponsor-initiated or investigator-initiated. For sponsor-initiated studies, the investigator should advise SIBCR as soon as the determination to participate in the study is made. Sponsor contact information including name, email and phone number will be needed. SIBCR will oversee the negotiation and establishment of a CRADA for the project. For investigator-initiated studies, the investigator should contact SIBCR as soon as a potential corporate funder is identified. In all cases, SIBCR will provide assistance with budget review and finalization.

 

When preparing the budget, the investigator and study staff should ensure that all costs for conducting the study will be covered. If VAPSHCS clinical services are used (e.g., laboratory, radiology, cardiology), the investigator or study coordinator must complete a Research Use Agreement form for each such service line prior to finalizing the study budget, or must obtain an equivalent memorandum of agreement with the relevant service line. VAPSHCS must be reimbursed for all services utilized in support of a research project, including any patient services for clinical studies that are in addition to those required for standard patient care. By agreement between SIBCR and VAPSHCS, the rate of reimbursement is 90% of the current Medicare charge for a given procedure, unless an exception is formally requested and approved. For more information on this, see the section below, “Reimbursing the VA for Clinical Costs.”

 

If the Clinical Research Unit will perform required procedures or otherwise assist in the study, those services should also be included in the budget. If applicable, other R&D Core costs should be included in the budget.

 

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 initiated nor any funds expended, except for reasonable and usual preliminary costs for project planning before its approval, prior to VA R&D Committee approval. R&D Committee approval will not be given until all committee and subcommittee reviews and approvals have been secured. This may take up to eight 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 the sponsor notifies the PI and/or SIBCR that a grant or project will be funded.

 

For studies with corporate funding, the standard procedure is for the CRADA to be negotiated at the same time that the project is undergoing review by required institutional committees.

 

The following are the relevant committees for approval of research projects as applicable:

  • R&D Committee
  • Human Subjects Review Subcommittee or Institutional Review Board (IRB)
  • R&D Biohazard Committee
  • R&D Safety Committee
  • Institutional Animal Care and Use Committee (IACUC)
  • Recombinant DNA Committee
  • Approval of the facility Radiation Safety Officer must be obtained for projects using radioactive compounds or procedures.

 

All subcommittee approvals must be completed prior to R&D Committee approval.

 

After a study has received all required approvals and funding has been received, an SIBCR project account will be opened. The account number will reflect the VA RDIS number assigned after R&D Committee approval.

 

Funds may be expended from the project account in accordance with the study budget, all relevant guidelines of the sponsor and SIBCR policy. Financial reports will be provided monthly to members for each project or separate fund.

 

For all studies that use VAPSHCS clinical resources, the VA Medical Care Appropriation must be reimbursed for any costs incurred for work over and above the standard care required for normal patient care. Study coordinators must ensure that the relevant service lines have current and complete information on actual usage. SIBCR will review projects at least annually to verify that bills of collection have been received for these services in accordance with the Research Use Agreement(s) on file.

 

SIBCR will send all required financial reports to sponsors. The principal investigator will be responsible for any scientific progress reports.

 

REIMBURSING THE VA FOR CLINICAL COSTS

 

This procedure applies to all extramurally-funded research projects administered by SIBCR, regardless of source (e.g., private industry, voluntary health organizations, NIH, or other federal grants). It covers all research projects approved for conduct by VAPSHCS that involve provision of medical care services, such as radiology, cardiology, laboratory medicine, or others as defined by service lines.

 

Research use of such services consists of:

  • Services provided over and above standard medical care for an eligible veteran;
  • Services provided to a non-veteran participating in a research project (except those provided under 38 CFR §17.85).

Prior to approval of a study, investigators should notify each required service of their intent and seek agreement with them to collaborate in the study. This review and approval will ensure the service has the wherewithal to provide the required study procedures.

 

At this stage, the investigator or designee should verify the exact CPT or LMIP code for the procedure requested and the charge per procedure. The charge will be the standard rate of reimbursement as set by agreement between SIBCR and VAPSHCS, which is determined to be 90% of the current Medicare rate. Note that Pharmacy and the Clinical Research Unit have separately determined charge schedules that are not encompassed by this procedure.

 

These written agreements, signed by the service line leader or designee and by the investigator and study coordinator, become a part of the approval packet for the R&D Committee.

 

After the approved study commences, each providing service must receive a completed Request for Procedure or Test form for each research subject receiving a medical care procedure or test as defined above. On a periodic basis, the service will compile an invoice of charges from research usage and present it to SIBCR for payment.

 

Rate Exceptions For Medical Service Reimbursement

 

Occasionally a research project may be proposed that would significantly further the VA mission but has unusually limited support from its sponsor. If the cost of medical service reimbursement is a specific obstacle to the conduct of such a study, the PI may request a special, project-specific exception to the standard rate.

 

The PI must prepare a written request for an exception to the rate, describing the particular value of the proposed project to VA patients and VA care, the source of funding and the nature of its limitations and a justification of the rate that is being requested. The written request will be reviewed by the relevant service line leader, the VAPSHCS Deputy Director or designee and the SIBCR Executive Director. These individuals will confer with each other and the PI and arrive at a consensus decision as to whether the reduced rate is granted. Such a rate may only be applied to the specific research project for which it was approved and must be approved prior to the project’s submission to the R&D Committee.

 

STUDY CLOSEOUT

 

A study account should not be closed in SIBCR prematurely. When the study is completed and all expenditures have been made including publication costs, the member should inform SIBCR to close the account. This closeout is usually contemporaneous with study closeout from the R&D list of approved projects.

 

For grants that require final reports to the sponsor, the grant account will not be closed until the final report has been submitted and accepted by the grantor.

 

Most granting agencies will require return of all unencumbered or unexpended 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.

 

Sponsors require requests for no-cost extensions to be received prior to the expiration date of the project. Due dates vary depending on the sponsor.

 

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 (“zero account”). These funds can be used for general research expenditures in compliance with Board-approved policies.

 

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