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PRE-AWARD

Research Grant Proposals | Application Components | Budget Considerations | Regulatory Approvals | NIH Links and Resources

 

 

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. This determination is made by discussing proposed grants 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 as well as NIH K and T awards.

 

 

RESEARCH GRANT PROPOSALS

 

SIBCR is available to assist Principal Investigators (PIs) and their staff with the process of submitting extramural grant proposals in accordance with the SIBCR grants submission policy.

 

A complete submission timeline can be found in the Deadlines section of this website. 

 

 

COMMON GRANT APPLICATION COMPONENTS

 

Internal SIBCR Documents

 

SIBCR obtains a signed copy of the Grant Review Form and a scientific abstract from the PI at least 5 business days before the grant is submitted to the sponsor. An SIBCR grant administrator obtains signatures from the VA service line leader and an SIBCR authorized signing official.

 

PIs must sign a PI Assurance Form at least 2 days prior to the sponsor deadline. The PI Assurance Form serves as the PI signature on proposals and progress reports. The NIH notice explaining this assurance can be found here. SIBCR also uses this form for non-NIH grants.

 

Sponsor Documents

 

Please note that this list is drawn from basic NIH grant proposal requirements and may not include all mandatory components. For a full description of NIH grant application requirements, please refer to their websites for electronic submissions and for submissions using the PHS 398 forms. Specific announcements may have other requirements, as may other sponsors.

 

A grant administrator can create a detailed checklist and timeline that is appropriate for a specific application, if requested. Here is an example of a Proposal Timeline and Document Checklist. SIBCR grant administrators assist as needed with the administrative sections of grant proposals.

  • Face Page (PHS 398)
  • Detailed Budget, please see links for additional information on personnel expenses and SIBCR’s indirect cost rate.
  • Budget Justification
  • Project Summary/Abstract
  • Project Narrative (brief statement describing the relevance of research to public health)
  • Facilities and Resources
  • Equipment
  • Biosketches for all senior/key personnel (page and publication limits apply). All citations should conform to NIH’s Public Access Policy for including PMCIDs, which may be found by searching in the PubMed database.
  • Introduction to Application (see NIH/other instructions for applicability)
  • Specific Aims
  • Research Strategy
  • Bibliography and References Cited (NIH's Public Access Policy applies)
  • Human Subject Sections/Vertebrate Animals Section
    • Protection of Human Subjects
    • Inclusion of Women and Minorities
    • Targeted/Planned Enrollment Table
    • Inclusion of Children
  • Select Agent Research
  • Multiple PI Leadership Plan
  • Letters of Support
  • Resource Sharing Plan
  • Appendices
  • Application Cover Letter
  • PHS 398 Checklist
  • Consortium Arrangement*

 

*Below is a general list of required components for subawards. Additional components may be required. Please be in touch with your grant administrator at least 45 business days prior to the sponsor deadline to allow sufficient time for review and sign-off at the participating institution. A Subrecipient Checklist may be sent to consortium participants to assist in the pre-proposal stage.

 

  • Subrecipient Commitment Form (signed)
  • PHS 398 Face Page (signed) and/or Letter of Intent
  • Statement of Work and/or Specific Aims
  • Detailed Budget and Budget Justification
  • Biosketches for all Senior/Key Personnel
  • Facilities and Resources Page
  • Equipment Page
  • PHS 398 Checklist

                        

BUDGET CONSIDERATIONS

 

Personnel

 

SIBCR has a federally-negotiated fringe benefit rate that is the same for all personnel regardless of the number of hours worked. It is listed on our Facts page.

 

There are three mechanisms potentially available to reimburse outside institutions for personnel effort on SIBCR grants: subawards with collaborating institutions; Joint Personnel Agreements (JPAs) with UW; and, in some limited circumstances, Interagency Personnel Act (IPA) Agreements with VAPSHCS.

 

More information about Personnel Agreements can be found in the Personnel Agreements section of the website and in the Personnel section of our website. 

 

Clinical Services Costs

 

When using VAPSHCS medical care services such as radiology, cardiology, laboratory medicine and/or surgery, proposal budgets must include sufficient funds to cover the cost of these services. This requirement applies to all extramurally-funded research projects administered by SIBCR, regardless of the funding source (e.g., private industry, voluntary health organizations, NIH and other federal agencies).

 

R&D Core Costs

 

Grant proposals that include R&D cores such as animal care, histology, tissue culture, or the Clinical Research Unit must request funds for these services at the application stage. More information on these costs is included in the Grant Expenditure section of this website.

 

 

REGULATORY APPROVALS

 

For all research studies, projects cannot be initiated nor can any funds be expended prior to VA R&D Committee approval. If there are issues relating to pre-approval costs, please contact a grant administrator about these preliminary costs.

 

R&D Committee approval is not given until all subcommittee reviews and approvals have been secured. This may take up to 8 weeks or more if IRB approval is required. In order to avoid delays in study start-up, the approval process should begin as soon as possible after the sponsor sends notification that the project will be funded. CRADAs, which are used for studies that are industry sponsored or industry funded, are negotiated simultaneously with the PI seeking VA approvals (especially IRB approval) to avoid a delay in study start-up. If any other subcommittee approvals are required, they need to be completed prior to R&D Committee approval. SIBCR grant administrators obtain subcommittee approvals from PIs and/or study staff to submit to sponsors during the Just-In-Time (JIT) phase of an award.

 

The following committees may be required to review and approve research projects depending on their content:

 

  • 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 (needs to be obtained for projects using radioactive compounds or procedures)
  • R&D Committee (required for all projects)

 

R&D Committee sends approval notification to SIBCR as soon as obtained to expedite project start-up.

 

It is a requirement that research projects not be initiated nor any funds expended until the appropriate regulatory approvals are in place. In addition, continued regulatory approvals are also mandatory. It is the responsibility of the PI to keep all applicable regulatory approvals current by working with the regulatory subcommittee(s). SIBCR verifies that all approvals are current by utilizing reports generated by VA R&D.

 

JUST-IN-TIME

 

The NIH and other sponsors use the JIT process to allow institutions to submit certain elements of the application after peer review and prior to making a funding decision.  A JIT request is not a guarantee of funding. A full description of the process at the NIH may be found in Section 2.5.1 (Just-in-Time Procedures) of the NIH Grants Policy Statement
 

Commonly requested elements include:

  • Certification of IRB approval of the project’s proposed use of human subjects
  • Verification of IACUC approval of the project’s proposed use of live vertebrate animals
  • Evidence of compliance with requirements for education in the protection of human research participants
  • Other Support pages for senior/key personnel (NIH example here)

Other program-specific information may also be requested using this procedure. 

 

After the JIT process is complete, the sponsor makes a final funding decision. If the grant is selected for funding, an award notice is issued to SIBCR.

 

Membership

 

If the project PI is not yet an SIBCR member and is otherwise eligible for membership, the PI will be proposed to the Board for membership approval at the time of funding.

 

  

NIH LINKS AND RESOURCES

 

Standard NIH Submission Dates  

 

Applying Electronically for NIH Grants

 

NIH SF424 Guide and Forms    The "Application Guide SF424 (R&R)" has detailed instructions for each of the application components.  There are also forms for electronic submissions.

 

NIH PHS 398 Forms and Instructions   The PHS 398 Forms and Instructions page has detailed instructions for each of the application components and forms for paper submissions.

 

NIH Biographical Sketch instructions and example   Please note, all citations should conform to NIH’s Public Access Policy including PMCIDs, which can be found by searching in the PubMed database.

 

NIH Grants Policy Statements can be found here.

 

 

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