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Proposal Development Process

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Face page and forms (personnel, resources) Budget. Idea (Specific Aims Section) ... Need to check with hospital as to charges ... Federal Contract Budget Development ... – PowerPoint PPT presentation

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Title: Proposal Development Process


1
Proposal Development Process
  • Develop an irresistible, fundable idea
  • Identify the funding source
  • Write the proposal
  • Submit proposal through institutional offices
    obtain regulatory committee review as necessary
  • Submit proposal to sponsor

2
Develop an irresistible, fundable idea
  • It is completely thought out
  • It is innovative
  • It is significant and will have an impact on the
    field
  • It is compelling
  • It catches the reviewers attention

3
Developing a Research Idea
  • An irresistible research idea doesnt develop by
    accident, but rather through
  • Hard work
  • Commitment
  • Planning
  • Preparation (e.g., participating in existing
    projects)

4
Developing a Research Idea
  • Identify your long-term goal(s)
  • Get to know your field - the people and the
    funding sources
  • Begin networking - professionally and socially.
    Success rarely develops out of shyness!
  • Be mentally prepared for rejection
  • Stick to the goal that you have chosen dont
    jump around

5
Identifying a Funding Source
  • Find the agency that fits the idea
  • Search the Internet
  • Stay aware of Requests for Applications (RFAs),
    Requests for Proposals (RFPs), and Program
    Announcements (PAs)

6
Find the agency that fits the idea
  • Know what an agency can fund
  • Ideally, funding your proposal should help the
    agency achieve its goals
  • Contact or visit the program officer and listen
    carefully
  • Encourage ORA to invite representatives of key
    funding agencies to your campus

7
Federal Sources of Research Funding
  • Department of Commerce
  • Department of Defense
  • Department of Education
  • Department of Energy
  • Department of Health and Human Services
  • Department of Veteran Affairs
  • National Endowment for the Arts
  • National Endowment for the Humanities
  • National Science Foundation

8
Selected NIH Extramural Programs
  • National Cancer Institute
  • National Eye Institute
  • National Heart, Lung, and Blood Institute
  • National Institute on Aging
  • National Institute of Allergy and Infectious
    Diseases
  • National Institute of Nursing Research
  • National Library of Medicine

9
Selected NIH Research Grant Categories
  • R01 Research Project Grants
  • R03 Small Grants
  • R15 Academic Research Enhancement Award
  • R21 Exploratory/Development Grants
  • R41, R42 Small Business Technology Transfer
    (STTR) Grants
  • R43, R44 Small Business Innovation Research
    (SBIR) Grants
  • P01 Program Project Grants
  • P30, P50, P60 Center Grants
  • T32 Institutional Training Grants
  • F-series Fellowships
  • K-series Research Career Awards

10
Private/Philanthropic Sources of Research Funding
  • Industry
  • National Associations/Societies
  • American Cancer Society
  • American Heart Association
  • American Psychological Association
  • Foundations
  • Robert Wood Johnson
  • Ford Foundation
  • Whitaker Foundation

11
Write the Grant Application
  • Plan, e.g., allow enough time
  • Prepare, e.g., read instructions
  • Persist, e.g., revise and resubmit
  • Perspire

12
Write the Grant Application
  • Make you application attractive, easy to read,
    and comprehensible
  • Use simple declarative sentences
  • Avoid weak words
  • Use eye-catching headlines that convey your point
  • Put the most important material up front
  • Use new paragraphs to emphasize concepts and
    specific points
  • Use interesting, easily understood illustrations

13
Write the Grant Application
  • Face page and forms (personnel, resources)
  • Budget
  • Idea (Specific Aims Section)
  • Supporting Idea, Concepts (Significance and
    Preliminary Studies Sections)
  • Details of the Plan (Methods Section)
  • Appendices

14
Specific Aims Section
  • One of the two most important sections in the
    grant application
  • One of the only two sections that will be read by
    all of the reviewers
  • It must quickly engender enthusiasm for your idea
  • The flow of logic must be compelling

15
Characteristics of Specific Aims
  • Two-to-Five, at most
  • Brief, focused, and limited in scope
  • Each must be an eye-catching headline
  • Each must flow logically into the next
  • None should be absolutely dependent on the
    outcome of another

16
Specific Aims Example
  • Specific Aims
  • Interferon-gamma has been referred to as the
    master cytokine because of its many effects…..
  • To accomplish the objectives of this
    application, we will pursue three specific aims
  • 1.Narrow focus to DNA segments that most likely
    regulate constitutive and stimulated
    transcription of the human ? chains gene
  • 2.Identify the constellation of DNA response
    elements and transcription factors that regulate
    constitutive transcription of the ? chains gene
  • 3. Determine how transcription of the ?
    chains gene is up-regulated after stimulation by
    two widely differing proinflammatory mediators,
    TNF-? and PGE2

17
Scope of Significance Section
  • Describe what is known
  • Describe what is not known
  • Describe what needs to be done
  • Emphasize how your results will meet the stated
    need

18
Writing the Significance Section
  • Write this section as one of the last
  • Cite review articles sparingly
  • Ensure that citations are fully up-to-date
  • Cite your reviewers (if not contrived)
  • Be critical of earlier work in this field
  • Logically build toward what you expect your
    contributions will be

19
Writing the Preliminary Studies Section
  • Inadvisable to submit without some preliminary
    studies
  • You must be able to convince the reviewer that
    you are not relying exclusively on the work of
    others
  • Describe published studies first, include limited
    technical data (one or two figures/tables)
  • Describe unpublished studies, include more detail

20
Scope of the Methods Section
  • What do you propose to do
  • How do you propose to do it
  • What results you expect and what they will mean
    in terms of the overall project
  • What might go wrong
  • What alternative approaches will be used to cope
    with potential problems

21
Writing the Methods Section
  • Organize the narrative according to the specific
    aims, with one section for each
  • Devote an equal number of pages to each aim
  • Use an organized presentation format
  • Never exceed the page limits specified in the
    instructions
  • Use appendices sparingly (if at all)

22
Writing the Abstract or Summary Section
  • The other of the two most important sections it
    will be read by all reviewers
  • Must convey all the applications essential
    information
  • Must be written in plain English
  • It must convey infectious enthusiasm for the
    project
  • This section should not be written until the
    application is complete
  • Extract all essential information from the grant
    verbatim and then edit to fit the space allowed

23
Budget Realities
  • Budget should never drive the proposal
  • Reviewers will invariably cut something
  • Most cuts are the fault of the applicant, not the
    reviewer
  • Reviewers - your peers - know how much things
    cost
  • Your request must be credible
  • Once credibility is lost, the budgetary ax will
    cut even deeper

24
Typical Budget Categories
  • Personnel
  • Consultants
  • Equipment
  • Supplies
  • Travel
  • Tuition/Fees

25
Typical Budget Categories
  • Patient Care
  • Alterations/Renovations
  • Other Costs
  • Consortium Costs
  • Indirect Costs

26
Personnel Budget
  • Expect personnel costs to be your highest
  • Ensure that you justify each person with respect
    to both effort and expertise
  • Percentage effort/salary can vary during the
    budget period
  • TBA positions are the most vulnerable
  • Credibility can be lost, either by over- or
    underestimating needs (number effort)

27
Consultants Budget
  • Consultation fee
  • Travel and per diem expenses
  • Letter of commitment
  • Biographical sketch
  • Justification

28
Equipment Budget
  • One of the most vulnerable categories usually
    because of poor justification
  • The equipment request must be congruent with your
    resources statement
  • Dont ask for a Cadillac if a Ford will do
  • Justify any dedicated need exhaustively can not
    be general purpose
  • Replacement items are also vulnerable unless
    thoroughly justified

29
Supplies Budget
  • Know the difference between equipment and small
    items that qualify as supplies
  • Lump supplies into logical categories
  • If possible, cost account each request dont use
    round numbers
  • Justify all requests
  • Be certain that your supply budget matches your
    narrative

30
Travel Budget
  • Be realistic
  • Travel must tangibly contribute justify who will
    travel and why
  • Itemize which meetings will be attended and
    cost-account accordingly
  • International vs. domestic travel

31
Tuition
  • Bona fide employer-employee relationship between
    student and organization
  • Reasonable compensation for work performed
  • Organizations practice is to compensate students
    similarly in non-sponsored activities as well
  • May be charged on an average rate basis

32
Patient Care Budget
  • Includes costs of routine and ancillary services
  • Routine services include regular room and dietary
    and nursing services
  • Ancillary services include x-ray, OR,
    laboratory,pharmacy, pathology
  • Patient stipends and other direct payments are
    classified as Other Expenses

33
Alteration and Renovation
  • Must be essential to the purpose of the
    grant-supported project
  • Does not include routine maintenance and repair
  • Can sometimes be considered Equipment Costs if
    renovation needed to install equipment or for its
    safe use

34
Other Costs
  • Include animal maintenance, patient travel, donor
    fees, publications costs, computer charges,
    rentals, leases, service contracts
  • Justify each request
  • Make sure that the budget matches the narrative
  • Service center charges must be consistently
    charged regardless of sponsor

35
Consortium Budget
  • Each participating consortium/contractual
    organization should submit a detailed budget,
    checklist, face page, budget justification
  • These budgets should include direct and indirect
    costs
  • Prime organization may calculate indirects on the
    first 25,000 of consortium budget

36
Budget for subsequent years
  • Be realistic with respect to duration
  • Provide a timetable, even if one is not required
  • If any subsequent year is increased by an amount
    greater than the rate of inflation, justify
    exhaustively

37
Budget Examples
  • NIH Modular Grant Applications
  • Clinical Trials
  • Federal Contracts

38
NIH Modular Grant Applications
  • Up to 250,000 direct costs per year
  • Request in modules of 25,000
  • NIH does not require detailed budget
  • Budget narrative for personnel, equipment, and
    consortium arrangements
  • Other support requested Just-in-time
  • 25 rebudgeting requirement eliminated

39
Modular Budget Development
  • Calculate total direct costs over all project
    years including one-time costs and escalation
  • Divide by number of years
  • Select the number of modules closest to that
    dollar level
  • Typically request same number of modules in each
    year

40
Modular Budget Page
  • Initial Budget Second Year Third Year
    Fourth Year
  • Period of Support of Support
    of Support
  • 150,000 150,000 150,000 150,000
  • Personnel
  • Sandy Smith, MD, Principal Investigator, (30
    effort) will be responsible for morphological and
    immunohistochemical characterization of eye,
    brain, and other tumors…
  • Alan Jones, PHD, Co-investigator, (10 effort)
    will develop the HPV E6 and E7 models of
    transgenic retinoblastoma mice…
  • Consortium
  • Approximately 15,000 Total costs for all years
  • Consortium with University of Texas x Domestic
    Foreign
  • George Poole, PhD (5 effort) will be responsible
    for production...

41
Modular Budget Page
  • Initial Budget Second Year Third Year
    Fourth Year
  • Period of Support of Support
    of Support
  • 200,000 175,000 175,000 175,000
  • Personnel
  • Sandy Smith, MD, Principal Investigator, (30
    effort) will be responsible for morphological and
    immunohistochemical characterization of eye,
    brain, and other tumors…
  • Equipment
  • Purchase of a Silicon Graphics Octane System is
    requested in the first year increasing requested
    budget in first year by one module
  • Consortium
  • Approximately 15,000 Total costs for all years
  • Consortium with University of Texas x Domestic
    Foreign
  • George Poole, PhD (5 effort) will be responsible
    for production...

42
Clinical Trial Budget Development
  • Sponsor often sets fixed price per subject that
    includes direct and indirect costs
  • Need to develop internal budget to confirm that
    study can be done for fixed price
  • Need to check with hospital as to charges
  • Need to identify all costs associated with trial
    including direct, indirect, and one-time charges

43
Federal Contract Budget Development
  • Part of the business plan
  • Need to provide supporting documentation for
    costs (i.e., cost data and judgmental factors)
  • Contract undergoes a price analysis
  • May need to develop small business subcontracting
    plan (if contract to exceed 500,000)

44
Types of Proposals
  • Solicited proposals
  • Unsolicited proposals
  • Pre-proposals
  • Continuation or Non-Competing proposals
  • Renewal or Competing proposals

45
Policy Considerations
  • Appropriateness
  • Principal Investigator Eligibility
  • Principal Investigator Responsibility
  • Conflicts of Interest
  • Consortiums
  • Consultants

46
Policy Considerations
  • Contracts
  • Intellectual Property
  • Limited Proposal Submissions
  • Subcontracts
  • Certifications Representations

47
Special Reviews/ Internal Approvals
  • University Review Form
  • Animal Subject Approval
  • Hazardous Materials/ Chemicals
  • Human Subject Approval (IRB)
  • Training Education

48
Principal Investigators Responsibility
  • Proposal format content
  • Adequate resources (space, cost share)
  • Special reviews and/or approvals
  • Conflict of interest
  • Subcontract documentation
  • Consultant documentation
  • University Proposal Review Form

49
Department Administrators Responsibility
  • Proposal Editing
  • Budget Preparation Costing
  • Identifying sources for matching and/or cost
    sharing
  • Collecting documentation to support costs
  • Preparing certifications representations
  • Coordinating the routing of proposal for review
    approval
  • Copying Mailing the proposal

50
Division Director/Department Chair Responsibility
  • Approve scientific integrity
  • Provide assurances
  • Determine appropriateness of time commitment
  • Availability of space
  • Cost share or matching fund

51
College or Management Center Responsibility
  • Ensure major commitments of resources
  • Confirm administrative components
  • Check for all required forms
  • Check for appropriate rates

52
ORA Responsibility
  • Proposal format content
  • Budget costing
  • Verification of cost share/matching funds
  • Verification of documentation for subcontractors
    and/or consultants
  • Review sign certs. reps.
  • Review sign proposal review form

53
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54
Appendices
  • Office of Research Administration-Staff
  • Controllers Office- Grants and Contracts
    Accounting-Staff
  • Management Centers- Staff
  • Commonly Requested Information
  • University Review Form
  • Foundation Relations Approval Form

55
The Award Notice
  • Sponsor Name and Award Number
  • Amount of the Award
  • Period of the Award
  • Method of Payment or Reimbursement
  • Reporting Requirements
  • Terms and Conditions

56
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58
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59
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60
Required Documentation
61
Budget Types
  • 2 Research
  • 3 Special Programs
  • 5 Training Fellowships
  • 8 Discretionary Funds

62
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63
Account Numbers
  • University Account Number
  • Parent Subaccounts
  • Cost Share Accounts
  • Preliminary Numbers

64
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66
Internal Notice of Award Section 1
67
Internal Notice of Award Section 2
68
Location Codes
  • 10 On Campus (CWRU, Triangle, BRB)
  • 40 University Hospitals of Cleveland (UHC)
  • 50 MetroHealth Medical Center (MHMC)
  • 70 Veterans Admin. Medical Center (VAMC)
  • 90 Off Campus

69
F A Base
  • 1 Salaries Wages
  • 2 Salaries, Wages Benefits
  • 3 Total Direct Costs
  • 4 Total Direct Costs less Tuition Fees
  • 5 Modified Total Direct Cost (MTDC)
  • excludes patient care cost, renovations
    equipment
  • 6 Modified Total Direct Cost (excludes
    subcontract amounts over 25k)

70
Internal Notice of Award Section 3
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72
Internal Notice of Award Section 4
73
Project Types
  • 01 Research
  • 02 Training
  • 03 Career Awards
  • 04 Equipment
  • 05 Fellowships
  • 06 Clinical Trails
  • 07 Program Projects
  • 09 Other/Discretionary

74
Award Mechanism
  • 1 Grant
  • 2 Contract
  • 3 Subcontract
  • 4 Purchase Order
  • 5 Cooperative Agreement
  • 6 Other

75
Billing Code
  • 1 Letter of Credit (e.g. NSF, NIH)
  • 2 Bill- Cost Reimbursement
  • 3 No Bill- Automatic Payments
  • 4 Bill- Fixed Price/ Periodic
  • 5 CWRU Discretionary Funds
  • 6 Scholarships Fellowships
  • 5 6 automatic budget increase with deposits

76
Letter of Credit Codes
  • 1207 NASA- Ames
  • 1208 EPA
  • 1209 NASA-Goddard
  • 1211 USAID
  • 1212 DeptED
  • 1213 NASA- Marshall
  • 1201 NSF
  • 1202 NIH
  • 1203 NASA-Glenn
  • 1205 DOE
  • 1206 NASA- Washington

77
Post Award Administration Project Directors
Responsibilities
  • Plan and Manage
  • Adhere to Terms Conditions
  • Technical and Fiscal Management
  • Adhere to CWRUs Policies Procedures
  • Review and Monitor Account Status
  • Comply with Report Requirements

78
Controllers Office Responsibilities
  • Maintain expenditure records
  • Provide monthly expense reports
  • Review expenditure transfers
  • Prepare and Submit Expenditure Reports
  • Transfer overdrafts and Unallowable expenses
  • Coordinate responses to audit reports

79
End of Budget Period
  • Non-Competing Continuation
  • Competing Renewals
  • Program Projects
  • Overexpended Accounts
  • Annual Financial Report

80
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83
Final Year of Project
  • Relinquished Grants
  • Final Financial Report
  • Final Invention Statement
  • Final Technical Report
  • Equipment Inventory
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