NIH Research Grant Proposal Preparation

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• NIH Research Grant Proposal Preparation
• slides suggestions collected over the years
• Examples dated (old screen shots)
• Basic messages still relevant
• Please read slide notes for guidance
• Originally targeted junior faculty seeking
  first R01

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http//grants.nih.gov/grants/OER.htm
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Types of Awards

• Research Project (R01)
• Small Research Project (R03)
• Exploratory Study (R21)
• Pathway to Independence (K99/R00)
• Career Development (K Award)
• Diversity Supplements

Funding Mechanisms Explained
http//grants2.nih.gov/grants/funding/funding_prog
ram.htm
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Types of Awards
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Types of Awards
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Types of Awards
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Types of Awards
http//grants.nih.gov/training/careerdevelopmentaw
ards.htm
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Types of Awards
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Types of Awards
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Types of Awards

• Pathway to Independence (PI)
• 150-200 awards in FY2006-2007
• Open to US citizens non-citizens
• Years 1-2 mentored post-doc phase
• Years 3-5 independent research
• Must obtain assistant professor position to
  move on to second phasegrants.nih.gov/grants/new
  _investigators/pathway_independence.htm

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Types of Awards
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Types of Awards

• Diversity Supplements
• Applicants from underrepresented racial and
  ethnic groups
• Applicants with disabilities
• Applicants from a family below established
  low-income thresholds
• Applicants from a disadvantaged social, cultural,
  or educational environment (rural, inner city)

http//grants.nih.gov/grants/guide/pa-files/PA-05-
015.html
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Types of Awards

• Request for Application (RFA)
• Program Announcement (PA)
• Cleared Concepts
• Research Priorities
• Program Areas

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http//grants2.nih.gov/grants/guide/index.html
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Types of Awards
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Types of Awards

• NIH Guide Table of Contents Weekly Notification
  Service
• listserv_at_list.nih.gov
• subscribe NIHTOC-L your name

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http//www.nia.nih.gov/GrantsAndTraining/
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grants.gov/search/subscribeAdvanced.do
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Types of Awards
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Types of Awards
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http//nihroadmap.nih.gov/
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Types of Awards

• New
• Non-competing Renewal
• Competing Renewal
• Revised (original submission plus up to 2
  revisions allowed)

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NIH Review Process

• NIH publicizes its research priorities to help
  investigators plan projects
• NIH staff members welcome contact from
  investigators
• NIH wants to fund solid research that advances
  public health

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NIH Review Process

• 43,069 applications in FY2005 (vs 27,798 in
  FY2000)
• Referral officer assigns applications to review
  group
• Referral officer assigns to Institute for
  funding
• Make this task as easy as possible!

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Your application is here.
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NIH Review Process

• Review assignments based on
• Cover letter
• Grant title
• Abstract
• Specific Aims
• Cover letter includes grant mechanism, prior
  contact with NIH program officers, and referral
  suggestions for institute/center, IRG (integrated
  review group), study section
• Referral takes up to 6 weeks

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NIH Review Process

• Electronic submission involves PI OSP
• Grants.gov can take up to 2 business days to
  acknowledge receipt of files
• eRA Commons can take up to 2 business days to
  acknowledge receipt
• PI OSP have up to 2 days to verify uploaded
  application (both must verify)
• Cover letter optional-but still important!

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NIH Review Process

• Scientific Review Administrator
• Reviews all applications
• Assigns 2 reviewers
• Assigns 2 discussants
• Determines policy for submission of
  supplementalmaterial by PI
• Determines if special reviewexpertise is needed

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http//grants1.nih.gov/grants/peer/comparison_eval
uation.doc
http//grants2.nih.gov/grants/guide/notice-files/N
OT-OD-05-002.html
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NIH Review Process

• Streamlined (unscored) applications
• All members designate half of all applications
  received as streamlined

• Applications streamlined by 2 or more members are
  not discussed or scored
• Streamlined applications returned to PI with
  comments only from assigned reviewers

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NIH Review Process

• Reviewers discussants evaluate non-streamlined
  applications
• Institute program officers can attend
• Summary statement prepared
• Members mark priority scores(1.0-1.5
  outstanding)
• Percentile based on ranking compared with
  applications reviewed at last 3 meetings

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NIH Review Process

• 120 hours to prepare R01 application
• 7-8 hours to critique (reviewers)
• lt1 hour to read (discussants)
• 15 minutes to discuss score (entire group)
• Do EVERYTHING Possible
• To Facilitate Review Process!

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NIH Review Process

• Institute Advisory Council
• Reviews summary statements
• Evaluates application for program relevance
• Approves funding
• Awards funding based on priority scores

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NIH Review Process

• 43,069 grants submitted (new, cont, suppl)
  9,599 funded (22.3) in FY2005
• 740 Roadmap submissions 127 funded (17.2)
• 221 NCRR submissions 31 funded (14.0)
• 666 NIAAA submissions 203 funded (30.5)
• 3,166 NINDS submissions 700 funded (22.1)
• 6,325 NCI submissions 1,292 funded (20.4)

Success rates http//grants2.nih.gov/grants/award
/success.htm
Trends http//grants2.nih.gov/grants/award/awardt
r.htm
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Improving Your Odds

• Read PAs RFAs
• Monitor institute research priorities
• Contact program officers in target institute
• Discuss your ideas, their needs

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Improving Your Odds
http//nccam.nih.gov/research/
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds

• Search CRISP for current past research in
  same or similar areas
• NIH likes to see their tools put to use
• Helps you avoid areas already well funded

http//crisp.cit.nih.gov/
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Improving Your Odds

• Identify best study section
• Study section rosters online
• Identify one or more institutes for funding

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http//cms.csr.nih.gov/
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds
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http//era.nih.gov/roster/index.cfm
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Improving Your Odds

• ALWAYS submit cover letter (paper electronic)
• Suggest specific study group for review
• Suggest one or more target institutes
• Refer to RFA or PA number and title
• Refer to program officer with whom you have
  been working
• Identify yourself as a new investigator

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Improving Your Odds

• New investigators are NOT penalized
• New investigators allowed higher payline
  priority score
• More emphasis on research potential than on
  track record
• More emphasis on research plan than on
  preliminary results

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http//grants.nih.gov/grants/new_investigators/ind
ex.htm
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Improving Your Odds
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Improving Your Odds
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Improving Your Odds

• Seek feed forward before writing
• Identify 2-4 specific aims
• Discuss hypothesis approach with grant-funded
  colleagues biostatistician
• Contact NIH program officer
• Contact fiscal/grants administrator

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Improving Your Odds

• Use short, concise sentences
• Make points clearly
• Use diagrams to illustrate models
• Use tables to summarize data
• NEVER assume reviewers know what you mean
• Never create additional work for the reviewer

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Improving Your Odds

• Organize application for logical flow of ideas
  actions
• Everything fits together
• Nothing is superfluous
• Nothing is omitted
• Time table is detailed realistic

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Improving Your Odds
http//grants.nih.gov/grants/grant_tips.htm
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Improving Your Odds

• Why you would not want funding
• Must think of innovative ideas
• Must do the work
• Must publish papers
• Must submit grant progress reports
• Must write yet more grants for continued funding

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Improving Your Odds

• How to Avoid Funding
• Recycle old ideas
• Skip literature review
• Avoid all contact with NIH
• Do not let anyone else read grant
• Wait until due date to contact research
  administration
• Save time dont read instructions
• Include jargon sweeping generalities

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Research Plan Strategies

• Specific Aims
• Background Significance
• Preliminary Studies
• Research Design Methods
• 25-page limit read instructions!

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Research Plan Strategies

• Specific Aims is the MOST important section of
  Research Plan
• Concise, valid, innovative hypothesis
• Achievable objectives that will provide useful
  data whether outcome is positive or negative
• Creates focus for entire application
• 1 page (bullet each aim separately)

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Research Plan Strategies

• Specific aims define methods
• Specific aims must be
• Tangible
• Specific
• Concrete
• Measurable
• Realistic

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Research Plan Strategies

• Specific Aims Pitfalls
• Lack of new, original, or innovative idea
• Fishing expedition
• Focus on method
• No relation to future research or public health
• Not measurable
• Incremental advance in knowledge
• Not achievable in time available

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Research Plan Strategies

• Background Significance reviews published
  unpublished data in field (supportive or not)
• Identify gaps in current knowledge
• Justify hypotheses approaches taken
• Emphasize significance of findings
• Clearly state public health implications
• 2-4 pages

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Research Plan Strategies

• Background Pitfalls
• Inappropriate, incomplete, or haphazard use of
  literature
• Questionable rationale for proposal
• Uncertainty regarding future direction or
  significance of results (esp if negative)
• Lack of knowledge of relevant published
  literature (including alternative theories or
  approaches)

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Research Plan Strategies

• Preliminary Studies struts your stuff
• Establishes feasibility of proposal
• Demonstrates your qualifications dedication
  to do the proposed work
• Shows the hypothesis can be readily clearly
  tested
• 5-6 pages

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Research Plan Strategies

• Preliminary Studies Pitfalls
• Lack of general research experience
• Lack of experience in essential methodology
• Lack of critical interpretation of preliminary
  data (whether performed by you or others)
• Lack of dedication to career in research
• Preliminary data not published (lots of abstracts
  with no articles shows lack of productivity
  commitment)

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Research Plan Strategies

• Research Design Methods should be the easiest
  section to write
• Detailed cookbook instructions for what exactly
  you will do
• Anticipate problems include Plan B
• Logical sequence timetable
• Design MUST achieve Specific Aims
• Show how results will lead to future
  experiments translation to practice

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Research Plan Strategies
www.ninds.nih.gov/funding/grantsmanship_checklist.
htm
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Research Plan Strategies

• Explain in detail for all anticipated results
• Analysis
• Interpretation
• Dissemination
• Application to future work

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Research Plan Strategies

• Research Design Methods Pitfalls
• Diffuse, superficial, unfocused design
• Methods do not test hypothesis or achieve
  specific aims
• Unrealistic timetable for methods
• No difficulties anticipated, no solutions
  proposed for potential problems
• Inadequate attention to data analysis,
  interpretation, and/or application

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Research Plan Strategies
From http//www.ninds.nih.gov/funding/grantsmansh
ip_mistakes.htm
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Research Plan Strategies
From www.niaid.nih.gov/ncn/tools/ap-bettr.htm
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Research Plan Strategies

• Specific Aims
• Specifically, we aim to
• A.1 Do x, y, z
• A.2 Show this that
• A.3 Demonstrate what works
• Background Significance
• B.1 Background info for specific aim A.1
• B.2 Background info for specific aim A.2
• B.3 Background info for specific aim A.3

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Research Plan Strategies

• Introduction to Revised Applications (1-3 p)
• Deferential grateful for reviewer input
• Quote points to address directly from critiques
  avoid paraphrasing, do not avoid or omit
  addressing any criticism
• Do NOT get in pissing match with reviewers
• Clearly concisely explain response
• Recognize you are not home-free not all
  weaknesses addressed in summary statement

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Research Plan Strategies

• Appendices do not stretch 25-page limit (sent
  only to primary reviewer)
• Include ?3 published papers or abstracts
  (nothing submitted or in prep)
• Include full-size or color versions of items in
  main application
• Include complete surveys, data collection
  tools, or other forms

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Research Plan Strategies

• Do NOT neglect Human Subjects or Vertebrate
  Animals sections
• Reviewers serve as temporary IRB application
  must provide as much detail for reviewers as for
  IRB
• Consider requirements for these sections when
  preparing Research Plan itself

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PHS 398

• NIH requires the use of 11 point font - Arial,
  Helvitica, Palatino, Linotype, or Georgia
  typeface
• NEW Section G Select Agent Research
• NEW Section I Multiple PI/PD Leadership Plan
• Pay attention to Data/Resource Sharing

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PHS 398

• NOT an IRS-style form package!
• Logical forms, simple instructions, useful
  information collected
• Used to determine
• Review assignment
• Qualifications of investigators
• Institutional compliance with NIH code
• Cost of research

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PHS 398

• Face Page
• Limit title to 81 characters including spaces
  punctuation
• Select title carefully used to direct review
  assignment
• Use funding cycle dates to calculate start date
  for example
  02/05/07 submission 12/01/07 start

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PHS 398

• Description Page
• Write abstract last to reflect entire application
  review revise carefully
• Be concise, clear, complete may be only text
  read by most reviewers
• Do NOT cut paste from the grant
• Clearly state public health relevance
  importance to NIH mission (electronic submission
  forces you to do this)

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PHS 398

• Key Personnel Page
• Key personnel are paid to participate in the
  grant-funded work cannot be changed without NIH
  notification
• Other significant contributors include unpaid
  consultants mentors with no committed percent
  effort (include biosketch but no other support)

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PHS 398

• Budget Pages
• NIH has sample modular budget pages
• Department fiscal/grant administrator can help
  with estimating costs calculating salaries

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PHS 398

• Personnel Pages
• Summarizes education, training, professional
  career highlights
• Lists publications (except those in prep or
  submitted) presentations
• Lists recent research support
• Establishes qualifications to do proposed work
  appropriateness for role on proposed study
• Only 2 pages for career info publications
  this restriction goes away with electronic
  submission

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PHS 398

• Resources Page
• Summary of physical space, equipment, personnel,
  other resources essential to study completion
• Letters of support required for shared resources
  critical to proposed work
• Justify reliance on external resources

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THE FUTURE (is now)

• NO standard application forms EACH funding
  opportunity will have its own application
  package
• Register for notification of subsequent changes
  to the application package
• NIH Forms Website has samples only do not use
  these for actual submissions

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THE FUTURE (is now)

• Office of Research (sponsored programs) must
  submit applications NOT PI
• Write down grants.gov tracking number
• Authorized institutional official AND PI must
  verify applications accepted at eRA Commons
• Do NOT verify garbled images if looks garbled
  when you view it, will look garbled to reviewers
• NIH has demo to practice application verification

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THE FUTURE (is now)

• Color welcome throughout narrative
• Do NOT include headers (PI name) or footers
  (page numbers) in narrative file will be
  automatically generated
• Less spent on paper referral-review process
  means more for grants

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Summary

• Fully develop study aims
• Contact NIH to discuss aims
• Review literature related to aims
• Design study to test achieve aims
• Read follow all instructions
• Be concise be complete
• Seek input early often