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NIH Research Grant Proposal Preparation

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Title: NIH Research Grant Proposal Preparation


1
  • 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

2
http//grants.nih.gov/grants/OER.htm
3
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
4
Types of Awards
5
Types of Awards
6
Types of Awards
7
Types of Awards
http//grants.nih.gov/training/careerdevelopmentaw
ards.htm
8
Types of Awards
9
Types of Awards
10
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

11
Types of Awards
12
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
13
Types of Awards
  • Request for Application (RFA)
  • Program Announcement (PA)
  • Cleared Concepts
  • Research Priorities
  • Program Areas

14
http//grants2.nih.gov/grants/guide/index.html
15
Types of Awards
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17
Types of Awards
  • NIH Guide Table of Contents Weekly Notification
    Service
  • listserv_at_list.nih.gov
  • subscribe NIHTOC-L your name

18
http//www.nia.nih.gov/GrantsAndTraining/
19
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21
grants.gov/search/subscribeAdvanced.do
22
Types of Awards
23
Types of Awards
24
http//nihroadmap.nih.gov/
25
Types of Awards
  • New
  • Non-competing Renewal
  • Competing Renewal
  • Revised (original submission plus up to 2
    revisions allowed)

26
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

27
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!

28
Your application is here.
29
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

30
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!

31
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

32
http//grants1.nih.gov/grants/peer/comparison_eval
uation.doc
http//grants2.nih.gov/grants/guide/notice-files/N
OT-OD-05-002.html
33
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

34
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

35
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!

36
NIH Review Process
  • Institute Advisory Council
  • Reviews summary statements
  • Evaluates application for program relevance
  • Approves funding
  • Awards funding based on priority scores

37
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
38
Improving Your Odds
  • Read PAs RFAs
  • Monitor institute research priorities
  • Contact program officers in target institute
  • Discuss your ideas, their needs

39
Improving Your Odds
http//nccam.nih.gov/research/
40
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41
Improving Your Odds
42
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43
Improving Your Odds
44
Improving Your Odds
45
Improving Your Odds
46
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47
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/
48
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51
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52
Improving Your Odds
  • Identify best study section
  • Study section rosters online
  • Identify one or more institutes for funding

53
http//cms.csr.nih.gov/
54
Improving Your Odds
55
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56
Improving Your Odds
57
Improving Your Odds
58
Improving Your Odds
59
Improving Your Odds
60
http//era.nih.gov/roster/index.cfm
61
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

62
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

63
http//grants.nih.gov/grants/new_investigators/ind
ex.htm
64
Improving Your Odds
65
Improving Your Odds
66
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

67
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

68
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

69
Improving Your Odds
http//grants.nih.gov/grants/grant_tips.htm
70
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

71
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

72
Research Plan Strategies
  • Specific Aims
  • Background Significance
  • Preliminary Studies
  • Research Design Methods
  • 25-page limit read instructions!

73
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)

74
Research Plan Strategies
  • Specific aims define methods
  • Specific aims must be
  • Tangible
  • Specific
  • Concrete
  • Measurable
  • Realistic

75
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

76
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

77
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)

78
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

79
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)

80
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

81
Research Plan Strategies
www.ninds.nih.gov/funding/grantsmanship_checklist.
htm
82
Research Plan Strategies
  • Explain in detail for all anticipated results
  • Analysis
  • Interpretation
  • Dissemination
  • Application to future work

83
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

84
Research Plan Strategies
From http//www.ninds.nih.gov/funding/grantsmansh
ip_mistakes.htm
85
Research Plan Strategies
From www.niaid.nih.gov/ncn/tools/ap-bettr.htm
86
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

87
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

88
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

89
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

90
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

91
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

92
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

93
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)

94
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)

95
PHS 398
  • Budget Pages
  • NIH has sample modular budget pages
  • Department fiscal/grant administrator can help
    with estimating costs calculating salaries

96
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

97
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

98
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

99
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

100
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

101
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
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