Grant Writing for Success Michael A. Sesma, Ph.D. NIMH Roger Sorensen, Ph.D., MPA NIAAA with inspira

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Grant Writing for Success Michael A. Sesma,
Ph.D.NIMHRoger Sorensen, Ph.D., MPANIAAAwith
inspiration from Anthony Coelho, Ph.D.
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• Objective Help You Secure Funding for Research

What is available? How to get some?
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• Important Things to Know (about this
  presentation)
• The handout material is a reference resource
• The handout contains more information than we
  will discuss
• Information that is important is repeated to
  remind you that it is important

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Good Grantsmanship Principles for Success

• Understand the Agency Mission
• Understand Peer Review
• Secure collaborators for areas in which
• you lack experience and training
• There are no competitors in science, there are
  only potential collaborators.
• Grant writing is a learned skill
• Grantsmanship is a full time job
• You are in control of your life

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Grantsmanship Myth and Reality
. . .not a process by which bad ideas get
transformed into good ones . . .but
instead, it is more often the case of a good idea
disguised as a bad one.
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Components of a Successful Grant Application
Bottom Line!

• Strong Idea
• Strong Science
• Strong Application

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What Determines Which Grants Are Funded?

• Scientific merit
• Program considerations
• Availability of funds

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Anatomy of Grant Process
Researcher Idea Institution
Program Announcement or RFA
Program Staff
Collaborators
Grant Application (R01, R03, R21, K01, K08, etc.)
Revision

National Advisory Council
Program Staff
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Understand the Agency Mission
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Understanding the Agency Mission

• NIH mission is based and defined in law
• Appropriations bills define expectations
• NIH must report to Congress that it has complied
  with the legislative expectations
• NIH reports to congress on success
• NIH funding dependent on success and compliance
  with the legislative mandate
• NIH success based on the success of the
  scientists it supports
• NIH wants you to be a successful scientist

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The NIH Research Mission

• NIH conducts and supports basic, applied,
  clinical and health services research to
  understand the processes underlying human health
  and to acquire new knowledge to help prevent,
  diagnose, and treat human diseases and
  disabilities.
• 24 (of 27) Institutes/Centers support research in
  a wide range of institutions

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The Mission
News, Highlights, Health Info Reflect the
Mission Priorities
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How do we set priorities?

• Relevance what do we need?

• Traction where are the opportunities?

• Innovation what is new?

Relevance Traction Innovation IMPACT
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Can you find the Mission and Research Priorities?
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Program Announcements Listed in the NIH GUIDE
with participating Institutes and Centers
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Current Program Announcements indicate priorities
for the institute
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Different Institutes can have overlapping
research priorities
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Purposeto promote the use of metabolomic
technologies in translational research in human
health and disease for the purposes of enabling
and improving disease detection, diagnosis, risk
assessment, prognosis, and prediction of
therapeutic responses. In addition to this
overall goal, specific scopes and objectives of
the participating ICs are presented below.
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Identify NIH Staff who can help you
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Identify NIH Staff who can help you Identify the
Institute where your work is relevant
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Grant writing is a learned skill

• Writing grant applications, standard operating
  protocols and manuals of procedures that get
  approved are learned skills
• Writing manuscripts that get published in peer
  reviewed journals is a learned skill

Grantsmanship is a full time job.
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The IDEA
Transformed
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Before You Start Writing

• Do your homework!
• Find the right institute
• Review institute FOAs (RFAs PAs)
• Find the right funding mechanism
• Know the review committee(s)
• Talk to program officer at appropriate institute

Theres no requirement that you do any of these!
Its up to you!
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Pre-Submission

• Get feedback program/outside
• reviewers/colleagues (needs planning)
• No trial balloons (NEVER!!!)
• Give your Grants Office time
• Get programmatic approval for gt 500K

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A Good Planning Strategy
Think before you write. Act (plan) before you
think.
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So WHY Plan?
You will have What? -- good
Science/compelling story How and when? --
the right mechanism Where? -- sponsor
Who? -- your team Opportunity for a reality
check Time on your side (i.e., much less
stress) A competitive edge (a better
proposal)
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Concept Development

• Focused sequence of studies that builds
• on one another and sets out to answer
• a particular question
• Planned studies that are
• -- hypothesis-based
• -- provide useful information regardless of
  outcome
• -- info from one study sets stage for others
• -- have contingency plan if studies do not work

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Concept Development
Questions to continually ask Yourself as you
develop your application -- What will be
learned? -- Why is this research important?
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Before Starting (i.e., the Act Part!)

• Talk to Program at appropriate Institute(s)
• Know your audience - review committee
• Read instructions for 424 RR/PHS 398 form
• Propose research that you are passionate
• about and totally committed to doing

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Before Starting (The Reality)

• It generally takes three to six months to write
• a grant application and another nine months
• or so from the time you send it in until you
• get funded therefore, planning is essential!!!
• Check with your institution's business office
  to see
• what deadlines they have -- you'll need to get
  their
• signature before you send the application to NIH
• Register on Grants.gov and the Commons
• Allow time for your own internal review and to
  make
• the revisions/edits from that review

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Planning Guide
call NIH
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The SCIENCE

• Select a fundamental question
• Transform idea(s) into an exciting story/
• scientific journey
• Build confidence and enthusiasm (and
• sense of importance/relevance of your
• particular research to the field)

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The RESEARCH PLAN (application format)

• SPECIFIC AIMS - what you will do
• BACKGROUND AND SIGNIFICANCE - why you are
  studying this problem
• PRELIMINARY DATA/PROGRESS - shows you can
  do the work
• RESEARCH DESIGN AND METHODS - how you will do the
  work

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Writing -- General Comments

• Investigate a significant issue in science
• Use clear and lucid language
• Propose a feasible project
• Create interest and build enthusiasm about the
  project
• Pay attention to packaging
• Never assume your audience will know what you
  mean

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Some Further Tips/Suggestions

• Remember your audience (reviewers are very
  busy) make it easy to follow your rationale,
  logic, planning, methods, analysis, and thinking
• Include basic information where necessary few
  reviewers (if any) will be EXPERTS in all aspects
  of your application
• Repetition repeat significance and what will be
  learned from experiments
• Wonderfully elaborate and detailed methods,
  techniques, and procedures are worthless if you
  do not convince reviewers that the study is worth
  doing in the first place!
• High tech is no substitute for solid, logical
  planning

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No Weak Links In Science/Hypotheses Rati
onale/Logic Design/Methods Preliminary
Data Analyses Personnel Budget
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NIH GRANT

Formula for Grant Success





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Elements of Grant Success
Good Ideas
Good Reviewers
Good Timing
Good Luck
Good Grantsmanship
Good Presentations
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Good Idea

• SIGNIFICANT?
• Does it address an important problem?
• How will scientific knowledge be advanced?
• INNOVATIVE?
• Builds upon or expands knowledge base
• Capable of making a difference
• UNDERSTANDABLE?

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Good Timing

• Will the idea be understood by others?
• Does it build upon existing knowledge?
• Does it build upon similar ideas?
• Do you have preliminary data?
• How will the idea be received?

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Good Timing is NOT
I plan on submitting a grant application in
two weeks. Can you tell me who might be a good
program person for me to speak with before I send
my application in?
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Good Presentation

• Organize the Application
• What do you want to do?
• Why do you want to do it ?
• How are you going to do it?
• What is the expected outcome?
• Why is it a good thing?

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Good Presentation Organize the Application

• Develop a logical outline (presentation
  sequence)
• Use Section Heading - help reviewers find
  things
• Use both major and minor section headings
• Make it easy for reviewers - Dont make them
  work
• Use a detailed table of contents
• Do everything to help reviewers
• Understand your idea,
• Why it is important and
• Why it is reasonable and feasible

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Good Presentation

• Address Review Criteria
• Significance
• Approach
• Innovation
• Investigator
• Environment

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Good Presentation Address Review Criteria

• (1) SIGNIFICANCE
• Does this study address an important problem?
• If the aims of the application are achieved, how
  will scientific knowledge or clinical practice be
  advanced?
• What will be the effect of these studies on the
  concepts, methods, technologies, treatments,
  services, or preventative interventions that
  drive this field?

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Good Presentation Address Review Criteria

• (2) APPROACH
• Are the conceptual or clinical framework, design,
  methods, and analyses adequately developed, well
  integrated, well reasoned, and appropriate to the
  aims of the project?
• Does the applicant acknowledge potential problem
  areas and consider alternative tactics?

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Good Presentation Address Review Criteria

• (3) Innovation
• Is the project original and innovative? For
  example Does the project challenge existing
  paradigms or clinical practice address an
  innovative hypothesis or critical barrier to
  progress in the field?
• Does the project develop or employ novel
  concepts, approaches, methodologies, tools, or
  technologies for this area?

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Good Presentation Address Review Criteria

• (4) Investigator
• Are the investigators appropriately trained and
  well suited to carry out this work?
• Is the work proposed appropriate to the
  experience level of the principal investigator
  and other researchers?
• Does the investigative team bring complementary
  and integrated expertise to the project (if
  applicable)?

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Good Presentation Address Review Criteria

• (5) Environment
• Does the scientific environment in which the work
  will be done contribute to the probability of
  success?
• Do the proposed studies benefit from unique
  features of the scientific environment, or
  subject populations, or employ useful
  collaborative arrangements?
• Is there evidence of institutional support?

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Good Reviewers

• Reviewer Good Reviewer
• Organize and make reviewers Happy
• Make it easy for them to understand things
• Make it easy for them to find things
• Make it easy for them to be your advocate
• Dont make them work hard

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Good Reviewers

• Factors Involved in Reviewer Assignment
• Abstract
• Specific Aims
• Methods Section
• Self Referral Letter - request specific study
  section
• Research the background of the review committee
• Letter to SRA recommending types of reviewers
• TYPES OF REVIEWERS NOT NAMES OF REVIEWERS

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Good Reviewers

• Know who the potential reviewers are and do what
  you can to control the selection process.
• Self Referral Letter - request specific study
  section
• Research the background of the review committee
• CRISP Database
• Rosters of Committees
• Letter to SRA recommending types of reviewers
• TYPES OF REVIEWERS NOT NAMES OF REVIEWERS

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Know the Review Committee(s)

• Why?
• Know the audience to whom you are
• writing (persuasive writing)
• Find the committee that has the best
• expertise to review your application

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Finding the Review Committee(s)

• Center for Scientific Review Groups
• http//www.csr.nih.gov/Committees/rosterindex.asp
  A
• NIAA Review Groups
• http//www.niaaa.nih.gov/extramural/subroste.htm
• NIDA Review Groups
• http//www.nida.nih.gov/IRGCouncil/IRGStructure.ht
  ml
• NIMH Review Groups
• http//www.nimh.nih.gov/Grants/PeerIndex.cfm

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Good Luck

• The consequence of
• Good Ideas
• Good Presentation
• Good Timing
• Good Reviewers
• Good Grantsmanship
• Luck is the residue of hard work!

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Good Grantsmanship

• A strong research application
• Has well-defined Specific Aims
• Proposes novel, interesting focused Hypothesis
  Driven experiments.
• Promises to Advance Knowledge.
• Provides supporting Preliminary Data.
• Has an appropriately detailed Experimental
  Design.
• Documents appropriate scientific Expertise.
• Has a reasonable justified budget.

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Submission

• Write cover letter
• Be proactive/know committee(s)
• Get dual assignment when
• appropriate
• Let funding agency know of your
• submission
• Wait patiently for the review outcome

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COMMUNICATE WITH NIH

• Program Staff
• Review Staff
• Grants Management Staff
• Improve your luck by preventing problems before
  they happen

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COMMUNICATING WITH NIH

• Before Submitting, Call Institute Program Staff
• Assess scientific interest and match
• What do they want to fund?
• Submit Your Application With a Cover Letter
• Institute interest
• Study Section Interest - Charter

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COVER LETTER

• Suggest Key Areas of Expertise Required
• Do Not Suggest Specific Reviewer Names
• Suggest Institute(s) For Potential Funding
• Suggest Study Section(s) For Review

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COMMUNICATING WITH NIH

• CONTACTS WITH REVIEW STAFF
• Scientific Review Administrator answers
• Questions about the review process
• Format and structure of application
• Oops missing material or late material

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COMMUNICATING WITH NIH

• AFTER REVIEW, CONTACT PROGRAM STAFF
• Institute Program Official
• Questions about the discussion of your
  application (after you have summary statement)
• Scores and percentiles
• Questions about the fundability of application

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NOW WHAT TO DO?!!

• Read summary statement
• Reread summary statement
• Talk with your Program Officer
• Wait for the AWARD, or
• Revise and Resubmit the Application

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REVISE RESUBMIT Do Not Appeal Review Outcome

• NIH Appeal Outcomes
• Council Denies Appeal (bad outcome)
• Council Accepts Appeal Original Application and
  Letter of Appeal is sent to the Same Study
  Section for a second examination and evaluation
  (bad outcome)
• Council Accepts Appeal Original Application be
  sent to a new Study Section but without the
  Letter of Appeal (bad outcome)

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REVISION COVER LETTER

• For Revisions, Indicate Review History
• Request Same Or Different Study Section
• Provide Justification for your request
• Dont be Argumentative ! Never!
• Dont be Abrasive ! Never!

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• Q What if you know that you are Right and the
  reviewers are Wrong, is it appropriate to argue
  your position in your resubmission
• A NO!
• Remember
• An application for funding is not about the facts
  of your completed research.
• It is about ideas and potential research
• Never be Argumentative !
• Never be Abrasive !
• Do not do longterm damage to yourself

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WHAT?!! You mean you want the revision of the
original revised revision to be REVISED?!!!
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REVISING RESUBMITTING

• Write A Clear Introduction Section
• Address All Criticisms Thoroughly
• Respond Constructively
• Accept the Help of Reviewer Comments
• Dont Be Argumentative !
• Dont be Abrasive !

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REVISING RESUBMITTING

• Update Preliminary Results
• Remember that Properly Revised
• applications can received
• fundable scores and subsequent
• Score can inform degree of revision necessary
• Maintain communications with
• Scientific Review Administrator
• and Program Official

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Top 10 Common Reviewer Concerns

• ..or How Not To Get DINGED!

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10 Concern

• This Application is not Appropriate for the Grant
  Mechanism
• A R21 is NOT a R01
• A Career Development Award is NOT a Research
  Project Grant

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9 Concern

• Experimental Details are lacking or have not been
  adequately provided
• Dont assume the reviewers know the methods
• Show the reviewers that you have thought about
  your research plan

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8 Concern

• Alternative Approaches or Interpretation of Data
  are Inadequately described
• Describe how you will analyze and interpret the
  data you collect
• Provide other experimental directions you might
  use should you encounter problems

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7 Concern

• The Background section is missing key
  publications and experimental findings
• Thoroughly describe the literature, especially
  controversies, but
• Support your views and ideas
• Be sure you have found key references

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6 Concern

• Preliminary Data is lacking
• Include preliminary data for all aims
• Use preliminary data to show knowledge of methods
  and data analyses

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5 Concern

• Im not sure that the Investigator can do the
  PROPOSED EXPERIMENTS
• Dont propose what you cant do
• Include Collaborators and Consultants on your
  project

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4 Concern

• The Proposal is OVERLY AMBITIOUS
• Set realistic goals for the budget and project
  period you propose

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3 Concern

• The Proposal is
• NOT MECHANISTIC, or
• NOT SCIENTIFICALLY RELEVANT
• Do not propose correlative studies
• Do not propose general observations

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In addition to proposing a research design that
is a fishing expedition.. ..the applicant
also proposes to use every type of bait and piece
of tackle known to mankind.
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2 Concern

• The Specific Aims do NOT TEST the Hypothesis,
• The Specific Aims DEPEND on results from previous
  aims
• The best proposals are those with independent
  specific aims that address your hypothesis using
  different approaches

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1 Concern

• There is not a CLEAR HYPOTHESIS
• Provide a focused hypothesis
• Describe the importance and relevance of your
  problem
• Be clear on how your project will move the field
  forward

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This application is characterized by ideas that
are both original and scientifically important.
.unfortunately the ideas that are
scientifically important are not original and the
ideas that are original are not scientifically
important.
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BEFORE YOU SUBMIT AN APPLICATION

• Show your application to a colleague
• Show you application to a colleague who knows
  little to nothing about your area of research and
  ask them if they understand
• What you are proposing to do?
• How you are proposing to do it?
• Why you are proposing to do it?
• If they do not understand Revise until they do
• Get feedback on clarity
• Get feedback on scientific merit

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AFTER NIH Receives Your APPLICATION

• Contact the SRA if there are potential problems
  of IRG assignment.
• Avoid additional material in support of your
  application,
• Speak to the SRA first.
• Keep the material brief - 1 to 3 page letter.
• Send it at least one month before the review
  committee meeting.
• Better yet Do NOT submit additional material

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AFTER REVIEW IS OVER

• The Program Official at the Institute to which
  your proposal was assigned is the new contact
  point.
• Address any concerns on review to them.
• Appeal letters are appropriate only if review was
  flawed (legal and procedural).
• More constructive use of your energy is amending
  and resubmitting the application and
  incorporating reviewer comments.
• Do not take the review comments personally.

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IF YOU RESUBMIT

• Answer previous critiques completely
• Supply an introduction section which explains the
  changes you have made
• Leave your irritations with the review out of
  your resubmission
• Dont argue or be hostile
• You will not be help yourself if you force the
  study section into a defensive posture
• Accept Reviewers comments and suggestions as
  helpful and incorporate them in your revision

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IF YOU RESUBMIT

• Remember that the study section will have the
  previous summary statement, but not the previous
  application.
• Do not refer to the previous application for
  details.
• Remember that reviewers are generally trying to
  help you become a better research scientist

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DO NOT write the application for Yourself Unless
you are going to fund it yourselfYou MUST
convince the entire review committeeand the
funding agency
Rule 1
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Rule 2
STUDY SECTIONS DO NOT FUND APPLICATIONS!
INSTITUTES FUND APPLICATIONS!
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Rule 3
You must Excite the reviewers and the funding
agency
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Rule 4
Reviewers are never wrong, Reviewers are never
rightthey simply provide an assessment of
material that you provided in your application
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Rule 5
Comments in the summary statement are never about
you as a person.The comments are about the
material that you provided in your application
and the way in which you provided the information
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Rule 6
The comments in the summary statement only list
some of the weaknesses . not all of the
weaknesses.When you revise your application use
the time as an opportunity to improve the entire
application.
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Rule 7
Always contact NIH staff before you submit an
application and preferably when you are in the
planning stages.Make sure that you give
yourself and the NIH staffer enough time to work
with together.
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Q. Do I really have to contact NIH before I
submit an application?

• A. Only if you want to get funded!
• Always contact program staff during application
  development
• Must contact IC staff prior to a submission if
  you want them to agree to accept the application
  for any investigator-initiated competitive
  applications with gt500,000 direct cost for any
  single year
• Request must be at least six weeks before deadline

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Focus Your ApplicationState a Clear
Hypothesis,Make sure the Specific Aims Test Your
Hypothesis
Rule 8
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Propose Mechanistic, Scientifically-Relevant
Experimentsthat will clearly and significantly
address an important research question
Rule 9
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Secure a Mentor(s) Who can provide advice and
guidanceSecure a Collaborator(s)Who can
provide needed experimental expertise
Rule 10
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EXAM Question
What are the Elements of the Formula Grant
Success?






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Grantsmanship

• Knowing Understanding
• What to do
• How to do it
• When to do it
• What to do when things dont go as planned
• Being willing to do what is needed
• Doing it- doing what is needed

Understanding Peer Review
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Be PERSISTENT!!!
PLAN Ahead!!!
And Dont Forget to talk with your PROGRAM
OFFICER!!!
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A Guiding Principle

• Your end product MUST
• be important
• be unique
• contribute significantly to the field

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NIH GRANT

Formula for Grant Success





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Thank You
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Resources
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Funding Opportunities Sites with important
information http//grants.nih.gov/grants/index.c
fm http//grants.nih.gov/grants/welcome.htmintrod
uction http//deainfo.nci.nih.gov/funding.htm http
//deainfo.nci.nih.gov/extra/extdocs/grantrevproce
ss.htm http//www.niaid.nih.gov/ncn/grants/default
.htm http//www.niaid.nih.gov/ncn/grants/charts/de
fault.htm http//www.niaid.nih.gov/ncn/glossary/de
fault.htm
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http//grants1.nih.gov/grants/OER.htm
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http//grants1.nih.gov/grants/grant_tips.htm
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http//www3.cancer.gov/admin/gab/02gpb/nci_grants_
bk.pdf
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http//deainfo.nci.nih.gov/consumer.htm
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http//deainfo.nci.nih.gov/consumer.htm
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How to Write a Grant Application http//grants2.n
ih.gov/grants/grant_tips.htm http//www.niaid.nih
.gov/ncn/grants/ http//deainfo.nci.nih.gov/EXTRA/
EXTDOCS/gntapp.htm http//12.46.245.173/cfda/CFDA_
Static/grant_proposal.html http//cpmcnet.columbia
.edu/research/writing.htm
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http//www.niaid.nih.gov/ncn/grants/
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http//deainfo.nci.nih.gov/extra/extdocs/gntapp.ht
m
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http//cpmcnet.columbia.edu/research/writing.htm
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http//www.wm.edu/grants/PROP/Ellens_how_to.html
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http//era.nih.gov/
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https//commons.era.nih.gov/commons/
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http//era.nih.gov/virtualschool/