Transcript Grantsmanship

Grant Writing
John Chae, MD
Case Western Reserve University
MetroHealth Medical Center
2007 Annual Meeting of the AAP
Disclaimer
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I’ve never taken a “class” on
grantsmanship
I’ve only written 5 unique NIH grants
in my career (R29, three R01s and
K24)
However, each, except one, was
funded the first time
“School of hard knocks”
Overview
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NIH
People
Types of Grants
K and R award Structure
Review criteria
Comments on other mechanisms
Review Process
What’s really important…
NIH
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Part of the Department of Health and Human Services
Consists of 20 Institutes and 7 Centers: Each are allocated a
budget
Institutes:
-Each institute has an identified domain and receives funding
to support research in these domains
-Each institute make final funding decisions
-Intramural and Extramural research
Centers
-Several function similar to an Institute
-Several provide infrastructure predominantly
-Several do both
NIH
Institutes of Interest
 National Institute on Aging
(NIA)
 National Institute of Arthritis
and Musculoskeletal and Skin
Diseases (NIAMS)
 National Institute of Biomedical
Imaging and Bioengineering
(NIBIB)
 National Institute of Child
Health and Human
Development (NICHD)
 National Institute of
Neurological Disorders and
Stroke (NINDS)
Centers of Interest
 Center for Scientific Review
(CSR)
 National Center for
Complementary and
Alternative Medicine (NCCAM)
 National Center for Research
Resource (NCRR)
 NIH Clinical Center (CC)
 Comment: National Center for
Medical Rehabilitation
Research (NCMRR)
People
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Scientific Review Administrator (SRA)Review group specific
Program Officers-Institute specific
Grants manager-Institute specific
Types of Grants
“Mechanisms”
 R: Field or investigator initiated research grants
-R03: Small grants (2-yrs, $100K, 10 p research
plan)
-R21: Exploratory grants (2-yrs, $350K, 15 p
research plan)
-R01: Traditional research grants (3 to 5-yrs, no $
limit, 25 page research plan)
 K: Career awards (5-yrs, salary + $25-50K/yr, 50 p)
 T: Training grants
 F: Fellowships
 P: Program Project or Center grants
K-Award (K23)
Section I: Administrative Data
 Face page
 Description, performance sites, key
personnel
 Table of contents
 Budget
 Biographical sketches
 Other support (for mentors)
 Resources
K-Award (K23)
Section II: Specialized Information
1. The candidate (25 pages)
A. Candidate background
B. Career goals and objectives: Scientific
biography
C. Career development/training activity
during award period
D. Training in the responsible conduct of
research
K-Award (K23)
2. Statement by Sponsor, Co-Sponsor(s),
Consultants and Contributors
3. Environment and Institutional Commitment
to Candidate
A. Description of Institutional Environment
B. Institutional commitment to candidate’s
research career development: 75%
protected research time
K-award (K23)
4. Research Plan
A. Specific Aims
B. Background and Significance
C. Preliminary studies/progress report
D. Research design and methods
E. Human Subjects Research
F. Vertebrate Animals
G. Select Agent Research
H. Literature Cited
I. Consortium/contractual arrangements
J. Resource Sharing
A-D: 25 pages
K23 Review Criteria
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Candidate:
-Quality of the candidate’s academic and clinical record
-Potential to develop as an independent clinical researcher
focusing on patient oriented research (POR)
-Commitment to a career in POR
Career Development Plan:
-Likelihood that the plan will contribute substantially to the
scientific development of the candidate
-Appropriateness of the content and duration of the proposed
didactic and research phases of the award
-Consistency of the career development plan with the
candidate’s career goals and prior research experience
-Quality of the proposed training in responsible conduct of
research
K23 Review Criteria
(cont’)
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Research Plan:
“Reviewers recognize that an individual with limited
research experience is less likely to be able to
prepare a research plan with the breadth and depth
of that submitted by a more experienced
investigator. Although it is understood that K23
applications do not require the level of detail
necessary in regular research grant applications, a
fundamentally sound research plan must be
provided. In general, less detail is expected with
regard to research planned for the later years of
the award, but the application should outline the
general goals of these years.”
K23 Review Criteria
(cont’)
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Research Plan (cont’)
-Appropriateness of the plan to the stage of research
development and as a vehicle for developing the research skills
as described in the career development plan
-Scientific and technical merit of the research question, design
and methodology
-Relevance of the proposed research to the candidate’s career
objectives
-Adequacy of the plan’s attention to including both genders and
minority subjects in projects involving human subjects
-Adequacy of plans for including children as appropriate for
scientific goals of the research, or justification for exclusion
K23 Review Criteria
(cont’)
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Mentor
-Appropriateness of mentor’s research qualifications in the area of
application
-Quality and extent of mentor’s proposed role in providing guidance
and advice to the candidate
-Previous experience in fostering the development of researchers
-History of research productivity and support
Environment and Institutional Support
-Institution’s commitment to the scientific development of the
candidate
-Adequacy of facilities and the availability of appropriate educational
opportunities
-Quality and relevance of the environment for scientific and
professional development
-Institution’s commitment to an appropriate balance of research and
clinical responsibilities
K23 Review Criteria
(cont’)
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Budget: Evaluate the justification of
the requested budget in relation to
career development goals and
research aims
Human Subjects: Assess risks and
benefits and data and safety
monitoring plan
Gender/Minority/Children inclusion
R Awards
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Same as K-award but without the Candidate section
Primary focus in the research plan:
A. Specific Aims
B. Background and Significance
A-D: 25 pages
C. Preliminary studies/progress report
D. Research design and methods
E. Human Subjects Research
F.
Vertebrate Animals
G. Select Agent Research
H. Literature Cited
I.
Consortium/contractual arrangements
J.
Resource Sharing
R-award Criteria
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Significance:
-Does this study address an important
problem?
-If the aims 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 preventive
interventions that drive the field?
R-award Criteria (cont’)
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Approach:
-Are the conceptual or clinical framework,
design, methods, and analyses adequately
developed, well-reasoned and appropriate
to the aims of the project?
-Does the applicant acknowledge potential
problem areas and consider alternative
tactics?
R-award Criteria (cont’)
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Innovation:
-Is the project original and innovative?
-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 a novel
concept, approaches, methodologies, tools,
or technologies for this area?
Other Mechanisms
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R03: Small grant
-$50K/yr, 2 yrs
-Pilot studies, 10 page Research Plan
-Preliminary study not needed
R21: Exploratory grant
-$350K over 2 yrs
-High risk, potential high yield
-Preliminary study not needed
-15 page Research Plan
Review Process
Dual level process
 Scientific Review
-Received by the Center for Scientific Review (CSR)
-CSR assigns the grant to a Scientific Review Groups (SRG), AKA
“Study Section”
*Musculoskeletal Rehabilitation
*Function, Integration, Rehabilitation Sciences Subcommittee
-Each SRG managed by a Scientific Review Administrator (SRA)
-Most SRG are not aligned with an Institute, but some are
-Peers, independent investigators for the most part
 Council Review
-Institute specific
-Peers, program officers
Review Process
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1-5 (1=outstanding)
-No specific instructions on how to weigh each
criterion
-Reviewer’s overall impression
Priority score: Rating of intrinsic scientific merit of
the proposed research (100-500)
Percentile: the relative rank of each priority score
(along a 100.0 percentile band) among the scores
assigned by a particular study section
Streamlining: Up to half of proposals are unscored
(bottom half of applicants, ~priority score 3.0 or
higher)
What really matters…
I will assume that you have a great
 idea
 mentor
 institution
What really matters…
Communicate!
 Write in English
 Learn to write!
 Use correct grammar
 Use correct spelling
 Keep it simple and
clear
 Don’t try to impress
 Write to a scientists
who is not in your field
Remember, the
reviewers are:
 Spending 6-10 hrs per
K-award application
 Fatigued
 Grumpy and irritable
 Not easily impressed
 Poorly paid
 Working above and
beyond their regular
work
What really matters…
Format
 Remember, reviewers are spending hrs
reviewing grants, their eyes are red and
glassy and they are fatigued
 They need to see!
 Follow instructions
 Watch margins
 Arial 11 or larger
 Include pictures and diagrams; a sea of
letters tend to merge into a blur
What really matters…
Read other people’s grants:
 Knutson R21:
153, 11%
 Chae single site R01
-Initial submission:
273, 49.4%
-A1:
170, 16.7%
-A2:
130, 1.0%
 Chae multi-site R01:
135, 3.1%
What really matters…
Start early
 Give yourself at least 4-mo to write a
R-award (~2 hrs/day)
 For a K-award, start earlier to identify
a mentor, establish a training plan,
research plan etc
 Get it done early
What really matters…
Have others read your application
 Independent investigators with a track record of
success
 Members of study sections
 Remember, it takes approximately 8 hrs to review a
K-award
 Don’t give it to your colleague last minute; give
them at least 2-wks
 Have a thick skin; they are trying to help you, not
humiliate you
 Take their feedback seriously
What really matters…
After you receive your score…
 Review your summary statement with your
mentor
 Follow up with your program officer
 Determine whether you’re in the fundable
range
 Determine whether the grant has merit for
resubmission
 Try, try again…
Summary
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NIH structure
People to know
Types of Grants
K and R Award Structure
Review criteria
Comments on other mechanisms
Review Process
How to write…