CARES_Resources

How to Submit a Proposal

CARES is available to assist Principal Investigators (PIs) and their staff with the process of submitting extramural grant proposals in accordance with the CARES grants submission policy.
 
Federal and other Nonprofit Funding Sources
CARES must review all grants prior to submission.  To submit a grant to an outside sponsor please contact Lauren Rich, Chief Executive Officer (708-343-6300), lauren.rich@va.gov to discuss appropriate timelines and requirements for submission.  
 
The items below are necessary to begin the process:
  • Name of Sponsor and link to the Program Announcement
  • Due Date
  • Subawards included
  • Foreign institutions involved
  • CARES will require a detailed budget for all projects.  Budget templates are available based on your particular circumstance
 
Basic Information for National Institutes of Health (NIH):
  • Only the subawardee’s direct costs count toward the annual total of $250,000 per year on a R01
  • Consortium F&A is listed on a separate line in the budget
  • CARES overhead is calculated on the first $25,000 of each subaward
  • Modular budgets are to be completed in $25,000 increments
 
Subcontracts require the following documents:
CARES as Prime
  • Institutional Business Address, DUNS number and Congressional District
  • Institutional Official Contact Information
  • Institution letter of intent:  signed by institutional official indicating OH rate and knowledge of NIH consortium grant policy
  • F&A Rate Agreement
  • List of Key Personnel and current biosketches
  • Letters of support from Key Personnel where necessary
  • Statement of Work: could be Scope or Abstract as well
  • Facilities and Other Resources
  • Equipment
  • Detailed budget
  • Budget Justification
  • CARES as Subawardee - will vary by Prime Institution
    • Institutional Letter of Support
    • Current IDC proposal
    • PI and key personnel biosketch
    • Budget (PHS 398 budget forms) and Justification
    • Facilities and Resources
    • SOW or abstract
 
Corporate Sponsored Projects
For investigator-initiated projects obtaining corporate support, a Cooperative Research and Development Agreement (CRADA) must be established between CARES, the corporate partner and appropriate VA affiliate.  Please contact Lauren Rich, Chief Executive Officer, (708-343-6379), lauren.rich@va.gov  Negotiation of CRADAs will be initiated by CARES once the investigator provides the required necessary information. All such CRADAs must be signed by the study sponsor, CARES and the Director of the appropriate VA affiliate.  
 
Clinical Studies 
For studies sponsored by commercial entities such as pharmaceutical or device companies, a Cooperative Research and Development Agreement (CRADA) must be established between CARES, the corporate partner and appropriate VA affiliate.  CRADAs are the contractual vehicle mandated by VA for use in such situations.
 
The investigator should advise CARES as soon as the determination to participate is made. Sponsor contact information including name, email, and phone number will be needed. CARES will oversee the negotiation and establishment of a CRADA for the project. CARES will also assist with budget review, negotiations and finalizations, including any requirement for human subject review costs. 
 
In preparing the budget, the investigator and study staff should ensure that all costs for conducting the study will be covered.  The appropriate VA affiliate must be reimbursed for all services utilized in support of a research project when;
 
A) The procedures or processes are not being performed by the investigator
or investigator’s study team 
B) the procedures are considered by the investigator and investigator’s supervisor
as beyond standard-of-care and 
C) the procedures are being performed solely for purposes of the research.  
 
In order to determine the cost if any to be reimbursed to the appropriate VA facility the following documents will need to be included in the IRBnet submission.  
  • Laboratory Sign Off Form
  • Pharmacy Sign Off Form
  • Radiology Sign Off Form
CARES will review the appropriate paperwork submitted as part of the R&D application to identify if any VA affiliate services are to be used (e.g. laboratory, radiology, surgery).  CARES will then allocate and reimburse the medical center for the appropriate portion of the income from the study 
 
The investigator should ensure that all regulatory and compliance issues are addressed, including possible requirements for an FDA Investigational New Drug application. 
 
If the investigator-initiated project is a clinical trial, the investigator must register the trial on the website ClinicalTrials.gov. 
 
VA Research and Development Committee (R&D Committee) Approval
For all research studies, projects cannot be initiated nor, can any funds be expended prior to VA Research and Development (R&D) Committee approval. If there are issues relating to pre-awards expenses please contact Lauren Rich lauren.rich@va.gov. 
 
The approval process for R&D and any other subcommittees (Human, Animal, and Biosafety) relevant to the protocol is conducted via IRBnet.  For additional information please contact Lisa Balsley, (708-202-5702), lisa.balsley@va.gov or Cathy Gilroy, (708-202-5696), catherine.gilroy@va.gov.  
 
For clinical studies the following additional documents are required:
  • Laboratory Sign Off Form
  • Pharmacy Sign Off Form
  • Radiology Sign Off Form
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