How To Write Your First Grant

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How To Write Your First Grant

• Penny Cook, Executive Director, Grants and
  Contracts
• Sara Rockwell, Ph.D., Director, Office of
  Scientific Affairs
• Professor of Therapeutic Radiology and
  Pharmacology
• Sponsors
• Office of Academic Development
• Grants and Contracts
• Office of Scientific Affairs
• July 27, 2005

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Today

• The funding environment today
• Your support
• Business Office
• Grant and Contract Administration
• Other
• Your responsibility
• Introduction to Sara Rockwell
• Writing your application
• Questions and answers

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Where To Get Help

• Department Business Office
• Grant and Contract Administration
• Other
• Sponsor

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The Funding Environment Today

• Competitive
• Reduced Budgets and/or years of support
• Falling paylines
• ERA
• Collaborative multidisciplinary
• Clinical relevance

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Departmental Business Office

• May provide assistance in
• Budget preparation
• Administrative pages
• Obtaining endorsement letters
• Preparing proposal summary sheet (Prosum)
• Procuring signatures
• Post award financial management

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Grant and Contract Administration

• Research available support
• Communicate changes in policy
• Review grants and contracts for policy and
  compliance
• Negotiate terms and conditions
• Require complete application at time of
  submission
• Primary contact with funding agency pre and post
  award
• GCFA

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Other Support

• HIC
• HIPPA
• IACUC
• Safety Office
• Conflict of Interest Office
• OCR

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Sponsor Life Cycle (NIH example)
Center for Scientific Review (CSR)
10,000 applications/cycle
Assignment
Integrated Review Group (IRG)
4 months
Assignment
Streamlining
Study Section
Priority Score
Summary Statement
3 months
Advisory Counsel
3 months
Award
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PI Responsibilities

• Appropriate institutional appointment
• Obtain space and resources
• Signed patent agreement
• Complete application materials
• Obtain Letters
• Adhere to GCA deadlines
• Send proposal to sponsor
• Manage post award administration
• Compliance reviews/training

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The writing process from the Principal
Investigators perspective

• When to start?
• At least three months in advance
• Longer for new project
• Longer for complex project
• Dont assume that at the end of a project cycle
  that renewal is automatic

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Deadline day in the NIH mailroom
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Where to find out about funding sources

• Talk with colleagues
• Talk with business office/chair
• Talk to Melanie Smith
• Databases on Grants and Contracts website
• Alert services
• Professional society websites
• YSM and Yale bulletin boards, announcements,
  e-mail list serves, etc.

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Research Grants and Career Development Awards

• Research grant focus is on project
• Career development award focus is on potential
  of applicant
• Different focus
• Different requirements
• Even when you use the same project for both you
  will write them differently

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You can (and probably should) apply for more than
one grant for a project

• Pay line is often at 20
• Same project to different agencies
• Research project plus career development award
• Acknowledge overlap in other support sheets
• If they are all funded
• Open champagne
• Decide which award (or awards) to accept and
  which to decline

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Limited competitions

• Scholars awards
• Usually career development grants often limited
  to new faculty
• Institution or department may be allowed only 1
  or 2 two candidates
• Internal competition to select Yales nominee(s)
• List on Grants and Contracts website
• Melanie Smith can send you information on those
  of interest to you

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Internal competitions

• Grants through programs at Yale or YSM
• Often limited to Yale researchers
• Generally in focused area
• Fellowships and research grants
• Generally small
• Often for pilot studies
• Sometimes limited to new investigators
• Can be very valuable
• Get preliminary data
• Establish independence and track record

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Where to start Gather information about possible
grantmakers

• Grantmakers areas of interest
• Grantmakers policies
• Amount and duration of funding
• Deadlines
• Instructions
• Application forms
• Procedures used to review grants
• Time until funding
• Probability of funding

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Responding to an RFA or RFP

• Some RFAs and RFPs are great opportunities
  others are not worth the effort
• Talk to the contact person
• Find out more about the request and the intent
  and scope
• Ask about review process -special panel or
  regular study sections?
• Is money set aside?
• How many projects will they fund?

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Reviewing and Funding are separate actions by
independent groups

• Study sections
• review applications for scientific merit
• prioritize by scientific merit
• Institutes and Programs fund projects
• consider the scientific merit
• also consider priorities of program
• consider balance of their portfolio
• may reach for applications in critical areas
• may skip applications of low interest to program

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Gather the information needed to plan and develop
your application

• Literature related to project
• Resources needed for project
• Techniques needed
• Possible collaborators and mentors
• People who can be asked to write letters
• Cost and budget information
• Make a list of the things you will need to do
  before submitting grant

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Some critical elements to think about before you
begin to write

• Are you eligible?
• Do you have the resources you need?
• Skills
• Equipment, facilities
• Support from department, institution
• If not, can you get them?
• What scope of project can you perform with your
  resources and time?
• Dont waste your time preparing grants that cant
  fly

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If you have questions

• Talk to Grants and Contracts
• Contact the grantmaker
• Program people (scientists)
• Administrators
• Talk to your business office
• Talk to experienced investigators in your field
  of research
• Senior investigators
• Young investigators, a couple years ahead of you
• Successful applicants for same grant

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Writing the application

• Format and content varies dramatically
• Read the instructions
• Follow them to the letter
• May need to alter focus
• May need to alter scope to match money and time
  available
• One size does not fit allor even most

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Parts of the application

• Cover sheets
• Abstract or abstracts
• Administrative elements
• Assurances
• Biosketches or CVs
• Scientific sections
• Letters (sometimes)
• Appendices (sometimes)

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The cover sheet

• Specific to agency and grant type
• Will have very specific format and instructions
• May require very specific (and sometimes very
  bizarre) information
• Some you will not know
• Go to Grants and Contracts website and business
  office for help
• May require signatures and assurances
• Must be complete and accurate

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Assurances

• With most grants you will see a terrifying list
  of required assurances
• Dont panic many will already have been handled
  by the institution
• You will need to handle
• Human subjects protection
• Animal welfare
• Safety
• Conflict of interest and commitment
• Patent assignment
• Will require reviews/approvals at Yale and may
  require discussion in the application

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Picking a title for your project

• Sounds trivialbut isnt
• Length may be quite limited
• Make it informative titles may be used to assign
  grants to review committees and reviewers
• Should be intelligible to a non specialist
• Dont use jargon
• Dont get cute

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Abstract

• Draft first rewrite when application is almost
  done
• May be the most important part of application
• Used to assign reviewers
• Read by all reviewers on panel
• The abstract should summarize your project,
  describe its importance, and make the reader
  excited about reading the application and funding
  the project

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Lay abstract

• Many foundations require a lay abstract
• Very important
• There may be non-scientists on the review panel
• Some foundations give these to their donors
• Can be difficult to write
• Write it for an intelligent non-scientist
• Describe project in non-technical terms
• Emphasize importance and relevance
• Ask some non-scientists to read and critique your
  draft of this abstract

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CV or Biosketch

• Very important element of any grant
• Critical for career development awards
• Primary reviewers will examine this carefully
• Other reviewers will look at it before and during
  meeting - especially if there are questions or
  problems
• Different from resume, full academic CV
• Focus tightly on information relevant to your
  research career and to the project

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Preparing the Biosketch or CV

• Funding agency may provide a form and detailed
  instructions
• Follow them exactly
• Do not alter order from that specified
• Proofread, proofread, proofread
• Do not exceed allowed length
• Sections usually included
• Current position
• Education
• Professional Experience
• Honors and Awards
• Publications

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Education and Experience

• Generally start with college
• Include areas of study and degrees earned
• Non degree programs and education may warrant
  inclusion
• All graduate and postdoctoral training and
  research should be included
• Broad outline start end dates, institution,
  city and state, mentor
• Dont give details
• Chronological, but watch order

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Biosketch Current position

• Current position - be sure it matches that on
  cover and elsewhere
• Use official University titles only
• Promotion in progress?
• List effective date
• List only those made in writing
• May be ask to provide documentation
• If application includes letter from the Chair or
  Dean, be sure it mentions the promotion.

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Experience and awards

• Experience goes beyond your primary appointment
• Secondary appointments
• Advisory boards
• Awards and honors
• Select with care
• Begin with college
• Do not include trivial awards
• Awards relevant to professional career
• Describe if implications unclear to outside
  observer

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Publications

• Follow instructions for format and content very
  carefully
• Reviewers will look at
• Number of publications
• Quality of publications
• Peer reviewed journals?
• Quality, impact of journals?
• Full article or brief notes and case reports?
• Position as author
• How many authors?
• Who are the authors?
• Negotiate authorships carefully

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Publications

• Include
• Papers published in peer reviewed journals
• Papers in press ( this means accepted for
  publication)
• Book chapters, papers in proceedings, reviews
  (may be separate)
• Abstracts - maybe. Specify and list separately
• Do not include
• Papers in preparation
• Papers submitted but not yet accepted
• Plan ahead - submit early
• Can sometimes send newly accepted papers after
  acceptance

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Publications

• NIH All publications in last 3 years and
  representative earlier publications pertinent to
  this application
• If you have more publications than can fit into
  the allowed space, include an opening statement
  such as Selected from a total of 195
  publications
• Some agencies ask for the total number of
  publications

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Budget

• Format and information required varies
  dramatically
• Some agencies specify a fixed budget and define
  how you must spend it.
• Some want details
• Some want none
• Give them what they want
• Use the forms or follow the format given in the
  instructions
• Check agency guidelines what costs are
  allowable and what are not?

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Developing your numbers

• Even if the agency doesnt want details, work up
  a detailed budget so you know what you can do
  with the funds available
• Use real numbers
• Real salaries and fringes
• Real costs of supplies, animal care, etc
• Include everything you will need
• Extrapolate costs to start date of grant
• Dont low ball
• Dont forget indirect costs

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Future years

• Extrapolate from first year
• Consider changes in project over time - the
  science and the budget should always correspond
• Project future salaries as accurately as possible
  
• Include expected raises and promotions
• business office can help here
• Increase other costs to allow for inflation

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PROBLEM NIH modular grants

• NIH now funds modular grants at a constant level
  for future years
• Allows carryover of funds
• Remember to plan for raises and inflation in
  deciding how many modules you request in the
  first year
• E.g. for 3 year grant use second year cost
  estimates, not current or first year cost
  estimates to develop the budget

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Budget justification

• Format and detail required vary greatly
• Follow instructions carefully
• Should justify your costs in terms of the science
  of the project
• Will be examined by study section members
  (scientists) during their review
• Will be examined by business people later

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Time and effort of investigators is often
examined closely

• Does it match the scientific activities you have
  described?
• Do you have enough time from the essential
  people?
• Do you have all the skills you need?
• Do you have enough technical support?
• A problem with many first applications is that
  the project cannot possibly be done with the time
  and resources available

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Expectations on time and effort

• Percent Salary Percent Effort
• If not, you must justify the difference
• No effort is allowed without salary support
• You cannot have more than 100 professional
  effort
• All Yale assignments
• All external professional activities
• Watch time and effort carefully

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Resources and Environment

• Space
• Equipment
• Core facilities
• Departmental
• School of Medicine
• University
• Expertise and facilities available from your
  co-investigators
• External resources to be used

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Resources and Environment

• For critical resources and expertise that you
  dont have yourself, get letters of collaboration
  
• You have an advantage by being at Yale
• Many talented scientists, willing to share their
  expertise and resources
• Great core facilities
• E.g. Keck center
• Internationally known
• Available on fee for service basis
• If youre going to use them, say so

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Scientific Sections

• Format varies with sponsor
• Follow instructions exactly
• Conform to required length
• Can be shorter
• Can never be longer
• Dont try to get around length limits by using
  tiny fonts, small margins or appendices.
• Many agencies return such grants without review
• Even if they dont, the reviewers are usually
  ruthless

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Scientific sections of an NIH RO1 application

• Specific Aims
• Background and Significance
• Preliminary Data
• Research Plan and Methods
• Literature Cited
• Appendices - sometimes

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Specific Aims

• Short paragraph describing overarching goal of
  project
• Brief list of specific things you plan to
  accomplish during the project
• 3 - 5 Aims
• May have sub-aims
• length 1/2 to 1 page
• Broad overview of goals, hypotheses to be tested
  and approaches to be used, in telegraphic form

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Background and Significance

• Give scientific background and context for
  project
• Establish importance and novelty of proposed
  project
• Review prior work in area of project and
  literature related to the project
• Goals of this section
• Orient reader to subject and importance of
  project
• Prove your knowledge of the area through a solid
  review and objective citation of prior related
  work

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Preliminary Studies

• Closely related studies by others
• Your own preliminary data
• Present your data carefully and clearly
• Use high quality graphs, photos, and tables
• Show, discuss appropriate controls
• Analyze appropriately
• Use appropriate statistics
• Interpret your findings carefully and critically
  acknowledge limitations of techniques and data

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The reviewers will examine the preliminary data
critically

• To evaluate the basis of the project
• To predict the chance of success
• To evaluate you
• Ability to develop and test hypotheses
• Ability to design rigorous experiments
• Expertise with experimental techniques
• Expertise in analysis of data
• Rigor in interpreting the data
• Ability to present findings clearly and
  effectively
• Sloppiness here is absolutely fatal

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Research Design and Methods

• Longest section of application
• Develop details of project

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Dont neglect the research design

• This section is not just methods
• Outline experimental plan
• Base on specific aims - restate aims and describe
  flow of experiments under each aim
• Develop logic of project
• Describe timeline, sequence of experiments
• Describe potential pitfalls and what you will do
  if they occur
• Think about clinical relevance

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Methods

• Describe methodology
• Cite appropriate references
• Establish your expertise with techniques to be
  used
• give citations to your work using the techniques
• provide accurate discussion of techniques and of
  their strength and limitations
• give methodology details where critical
• describe alternatives to be used if a technique
  is inadequate or the results are inconclusive

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For techniques that are new for you

• Tell how you will obtain expertise
• Collaborator
• Yale
• include as investigator
• include biosketch
• Outside
• consultant biosketch, letter,
• subcontract agreement between institutions
• Someone who will teach you the technique
• Letter
• Biosketch
• Use core facility

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Literature Cited

• Follow required format exactly
• Be complete, but not silly
• Be accurate
• read entire article carefully
• cite accurately
• Include your own work but also cite others,
  including competitors
• Be objective dont ignore literature you dont
  like. Discuss it.

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Appendices

• Follow instructions carefully
• Some applications will have mandatory appendices
• Some will not allow appendices
• Some will limit appendices
• Possible appendices
• Letters of collaboration
• Letters or recommendation
• Papers, manuscripts

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Warnings about appendices

• Only the primary reviewers will have them
• Most reviewers will never see them
• Do not try to use them to circumvent page
  limitations
• Do not use them for critical information put
  that in the application
• They will not be attached to the application -
  label them clearly

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Letters of Recommendation

• Sometimes required
• Examined with great care
• Should discuss your past and current work and
  your long range potential in your chosen
  profession
• Select sponsors carefully
• Scientific references, not personal references
• Ideally, include thesis advisor, postdoctoral
  advisor, and someone who knows present work
• Select people who know your work, are reasonably
  senior, and know how to write good letters

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When requesting letters

• Provide instructions from grantmaker
• Specific format may be specified
• Specific information may be requested
• Provide your current full CV
• Provide a good draft of the proposal
• Talk with them about your long term plans and
  goals
• Provide a draft letter giving an overview of the
  project and your goals. Include any elements you
  want to see included

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You may also need a letter from your Chair, the
Dean, or the President

• The Chair may know you well
• provide draft letter
• provide all information given to others writing
  letters
• The Dean and President are less likely to know
  you well
• Dont panic
• GC and Development will arrange and help
• Will need information described above
• May call you for additional information
• May ask your mentor or Chair for draft letter

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More on letters

• Dont be shy about asking for letters
• Its part of the senior facultys job to mentor
  you and do these things
• Make their job as easy as possible
• Approach them early - give them enough time
• Multiple requests are not a problem
• Second and subsequent letters are easy
• Computers are our friends
• Be sure to let your writers know when you get an
  award

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Readers

• Begin asking people to read the grant at an early
  draft stage (2 months before submission)
• Use their input and feedback as you develop the
  project
• Do this early enough that you can add or delete
  experiments, aims, and collaborators
• Projects evolve while they are being written

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Who should read the final drafts?

• All collaborators must have an opportunity to
  read the proposal
• Anyone who is writing a letter for you should be
  given a draft
• Outside readers
• An expert in the field
• A person in a closely related field
• An intelligent non-expert
• A good proofreader good English skills
• This reader will provide a critical perspective
  if there are non-scientists on the review panel

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A word on readers

• You want people who are honest and critical
• You want both scientific comments and editorial
  comments
• Pick people who will take the time to read
  thoroughly and thoughtfully
• Yes, it is an imposition to ask a senior
  colleague to read your grant
• Ask anyhow
• Its part of their job
• Give them enough time
• With your peers trade favors

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The final proofreading

• Use spell check program
• Use grammar check program
• Dont trust these programs - proofread!
• principle investigator
• hear at Yale, we
• Have multiple people proofread
• Check figures, tables, data, legends
• If your English skills are not strong, get
  someone with strong English skills to edit and
  proofread for you

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Assembling the application

• Follow instructions to the letter
• Where/how to number pages?
• What order for sections?
• How to handle appendices?
• How many copies?
• Staple copies or not?
• Identify proprietary or confidential information?
• You dont want it sent back!!

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Sending the application

• Paper or electronic?
• Where?
• How?
• With cover letter?
• You may be able to request specific review
  committee
• You may request that specific people not review
  the application
• Watch for special instructions on RFAs

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Now what?

• You wait
• Will get acknowledgement and information on
  assignment for review and contact person
• The review can take months
• In some cases you may be asked for additional
  information - send ASAP
• In some case you may wish to send new information
  - contact before sending

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Problems in grants NRFC. NCI Staff

• 98 Preliminary Data Quality, relation to
  project
• 85 Experimental plan too ambitious, no
  preliminary data to support project, project not
  feasible, conceptual flaws, lack of detail in
  plan or methods, lack of alternative strategies,
  necessary reagents not available or not
  characterized
• 70 Not innovative
• 58 Hypothesis not clear
• 50 Significance not clear
• 40 Expertise not clear needed letters from
  collaborators or needed input from collaborators
  during preparation of application (often for
  analysis, interpretation)
• 25 Statistics inappropriate or lacking

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A final word

• NIH receives about 40,000 grant applications each
  year
• Each Study section reviews 80-100 grants per
  session
• Each reviewer is assigned 10-20 grants to read
  make yours the best one your reviewer reads, so
  he/she fights for it.

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Questions?

• For Me
• Penny Cook
• Melanie Smith
• Anyone else in room