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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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Typical Budget Categories

• Personnel
• Consultants
• Equipment
• Supplies
• Travel
• Tuition/Fees

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Typical Budget Categories

• Patient Care
• Alterations/Renovations
• Other Costs
• Consortium Costs
• Indirect Costs

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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)

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Consultants Budget

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

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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Required Documentation
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Budget Types

• 2 Research
• 3 Special Programs
• 5 Training Fellowships
• 8 Discretionary Funds

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Account Numbers

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

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Internal Notice of AwardSection 1
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Internal Notice of AwardSection 2
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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)

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Internal Notice of AwardSection 3
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Internal Notice of AwardSection 4
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Project Types

• 01 Research
• 02 Training
• 03 Career Awards
• 04 Equipment
• 05 Fellowships
• 06 Clinical Trails
• 07 Program Projects
• 09 Other/Discretionary

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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

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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

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Post Award AdministrationProject 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

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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

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End of Budget Period

• Non-Competing Continuation
• Competing Renewals
• Program Projects
• Overexpended Accounts
• Annual Financial Report

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Final Year of Project

• Relinquished Grants
• Final Financial Report
• Final Invention Statement
• Final Technical Report
• Equipment Inventory