NIH Grant Writing Tips
Kelli A. Komro, MPH, PhD
Associate Professor, Department of Epidemiology
and Health Policy Research, COM
Associate Director, Institute for Child Health Policy
www.ehpr.ufl.edu
www.ichp.ufl.edu
komro@ufl.edu
Outline
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My background
NIH structure and budget
Types of awards
Peer review process
Grant writing tips
UF NIH investigators & grant writing course
– CRISP: http://crisp.cit.nih.gov/
– ICHP: www.ichp.edu
Research Background
Research Experience
• PhD in Epidemiology, 1994, University of Minnesota
• Associate Professor, EHPR and Associate Director, ICHP
• $29M in grant funding, mostly NIH
• Child & adolescent health; community-wide preventive
interventions; group-randomized trials
• Mentor graduate students and junior faculty
Grant Review Experience
• NIH grant reviews
• UK’s Medical Research Council
Goal: To adapt, implement and evaluate an alcohol
preventive intervention for urban young adolescents
U.S. Department of Health and Human Services
The
Secretary
Deputy Secretary
Administration for
Children and Families
(ACF)
Administration on
Aging
(AoA)
Food and Drug
Administration
(FDA)
Centers for Medicare
and Medicaid Services
(CMS)
Agency for
Health Care Policy
and Research
(AHCPR)
Indian Health
Services
(IHS)
Centers for
Disease Control
and Prevention
(CDC)
Agency for Toxic
Substances and
Disease Registry
(ATSDR)
Substance Abuse and
Mental Health Services
Administration
(SAMHSA)
Health Resources
and Services
Administration
(HRSA)
National Institutes
of Health
(NIH)
Program Support
Center
(PSC)
National Institutes of Health
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.
NIH Funding
• Increase in applications & applicants
• Flat budget & inflation
• Success rates per application
– 2008: 19%
– 1999: 27%
• Strategies to encourage and support junior
scientists
– 2009 payline: 25%
National Institutes of Health
Office
Officeof
ofthe
theDirector
Director
National
NationalInstitute
Institute
on
onAging
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NationalInstitute
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on
onAlcohol
AlcoholAbuse
Abuse
and
andAlcoholism
Alcoholism
National
NationalInstitute
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of
ofAllergy
Allergyand
and
Infectious
InfectiousDiseases
Diseases
National
NationalInstitute
Institute
of
ofArthritis
Arthritisand
and
Musculoskeletal
Musculoskeletal
and
andSkin
SkinDiseases
Diseases
National
NationalCancer
Cancer
Institute
Institute
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NationalInstitute
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of
ofChild
ChildHealth
Health
and
andHuman
Human
Development
Development
National
NationalInstitute
Instituteon
on
Deafness
Deafnessand
andOther
Other
Communication
Communication
Disorders
Disorders
National
NationalInstitute
Institute
of
ofDental
Dentaland
and
Craniofacial
Craniofacial
Research
Research
National
NationalInstitute
Institute
of
ofDiabetes
Diabetesand
and
Digestive
Digestiveand
and
Kidney
KidneyDiseases
Diseases
National
NationalInstitute
Institute
on
onDrug
DrugAbuse
Abuse
National
NationalInstitute
Institute
of
ofEnvironmental
Environmental
Health
HealthSciences
Sciences
National
NationalEye
Eye
Institute
Institute
National
NationalInstitute
Institute
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ofGeneral
General
Medical
MedicalSciences
Sciences
National
NationalHeart,
Heart,
Lung,
Lung,and
andBlood
Blood
Institute
Institute
National
NationalHuman
Human
Genome
GenomeResearch
Research
Institute
Institute
National
NationalInstitute
Institute
of
ofMental
MentalHealth
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National
NationalInstitute
Institute
of
ofNeurological
Neurological
Disorders
Disordersand
and
Stroke
Stroke
National
NationalInstitute
Institute
of
ofNursing
NursingResearch
Research
National
NationalInstitute
Instituteof
of
Biomedical
BiomedicalImaging
Imaging
and
andBioengineering
Bioengineering
National
NationalCenter
Center
for
forComplementary
Complementary
and
andAlternative
Alternative
Medicine
Medicine
National
NationalCenter
Center
for
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Research
Resources
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Information
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Scientific
ScientificReview
Review
A Typical Institute/Center
National
Advisory
Council
Office of the IC
Director
Extramural
Board of
Scientific
Counselors
Intramural
Scientific
Programs
Grants Contracts
Laboratory
Studies
Clinical
Studies
Institute/Center Program Officers
• A scientist and administrator
• Manages grants, contracts, cooperative
agreements
• Identifies needs in scientific areas
• Identifies scientific areas of special interest
and communicates interest
• Monitors research progress
• Advocates for the best science
Institute/Center Strategic Plans
• Institute/Center web sites
• Strategic plans
– http://report.nih.gov/strategicplans/index.aspx
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Priority areas
Program Announcements (PAs)
Request for Applications (RFAs)
American Recovery and Reinvestment Act
– $10.4 B in support of scientific research
priorities, available for two years
National Institute for Child Health
and Human Development
ARRA Priorities
• GO Grants, due May 27, 2009
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Developmental Biology and Perinatal Medicine
Maternal and Child Health
Contraception, Reproduction and Population Research
Medical Rehabilitation Research
• Challenge Grants, due April 27, 2009
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Behavioral interventions
Clinical research
Comparative effectiveness research
Health disparities
Etc.
• Supplements to existing NIH grants, various dates
Most Common NIH Grant Types
• Small Grants Program (R03)
– 2 years
– Up to $50,000 per year
– 10 page proposal
• Regular Research Awards (R01)
– Up to 5 years
– Research costs not limited, but need permission to
submit budget of over $500,000 in direct costs in any
year
– 25 page proposal
Mentored Career Development Awards
• Mentored Research Scientist Development Award (K01)
• Mentored Clinical Scientist Development Award (K08)
• Career Transition Award (K22)
• Mentored Patient-Oriented Research Career
Development Award (K23)
• Mentored Quantitative Research Career Development
Award (K25)
Features of the Mentored Career Awards
• Purpose:
– Provide applicant with professional degree three-five years
of additional supervised research
– Training must be in an area new to the applicant and/or one
in which additional supervised research experience will
substantially add to the research capabilities of the applicant
– Focus on progression to independence: The candidate must
provide a plan for achieving independent research support
by the end of the award period
• Allowable Costs:
– Annual Salary $48,000-90,000
– Research Development Support up to $50,000 per year
Review Criteria for Mentored Career
Development Awards
• Candidate:
– Quality of the candidate's research, academic and/ or clinical
record
– Potential to develop as an independent researcher; and
commitment to a research career
• Career Development Plan:
– The content, phasing, and duration of the plan
– Consistency with the candidate's career goals
– Likelihood the plan will contribute to achieving of scientific
independence
• Research Plan:
– Methodology
– Relevance to the candidate's career objectives
– Appropriateness of the plan to the stage of research development
– As a vehicle for developing research skills for career development
Review Criteria for Mentored Career
Development Awards
• Mentor/Co-Mentor:
– Research qualifications
– Quality and extent of mentor(s) role in providing guidance
– Previous experience in fostering the development of researchers
– History of research productivity
– Adequacy of support for the proposed research project
• Environment and Institutional Commitment:
– Adequacy of research facilities and training opportunities
– Quality of the environment for scientific and professional development
– Institution's commitment to candidate—assurances that the institution
intends the candidate to be an integral part of its research program
– Institution's commitment to an appropriate balance of research and
other responsibilities including 75% effort proposed by the candidate
Career Development Plan
Pre-Doctoral
Fellowship-F31
Institutional Pre-Doctoral
Fellowship-T32
Post-Doctoral
Fellowship-F32
Institutional Post-Doctoral
Fellowship-T32
Do I need more training or changing career emphasis?
Yes
No
Apply for
Mentored K
Do I have pilot data?
Yes
R01
No
Apply for R03/
B/START
Applications for NIH Research Grants
Grants are normally submitted to NIH in three ways:
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Unsolicited Grant Application
Program Announcement (PA) - Institute or Center is
inviting grant applications in a general scientific area of
research. There are generally no funds set aside for
these projects.
A Request for Applications (RFA) - one or more NIH
Institutes and Centers invite applications in a welldefined scientific research area. Specific funds are set
aside for the projects.
NIH Guide for Grants and Contracts
How do I find out about NIH PAs and RFAs?
The NIH Guide Announces NIH Scientific
Initiatives provides NIH Policy and
Administrative Information. See:
http://www.nih.gov/grants/guide/index.html
Dual Review System for
NIH Grant Applications
Scientific Review Group (SRG)
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Provides Initial Scientific Merit Review of
Grant Applications
Rates Applications and makes
Recommendations for Appropriate Level of
Support and Duration of Award
Second Level of Review:
Institute or Center Council
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Assesses Quality of SRG Review of
Grant Applications
Makes Recommendation to Institute Staff
on Funding
Evaluates Program Priorities and
Relevance
Advises on Policy
NIH Peer Review Process
The reviewers study each application individually before the
meeting; and for each application, some reviewers are
assigned to prepare written critiques.
Those projects deemed most competitive, approximately the
upper third, are fully discussed and given a priority score
based on the scientific merits of the project.
Review Criteria
• SIGNIFICANCE
• APPROACH
• INNOVATION
• INVESTIGATOR
• ENVIRONMENT
Review Process for A Grant Application
Submitted to CSR, NIH
National Institutes of Health
Research
Grant
Application
Initiates
Research
Idea
School or Other
Research Center
Center for Scientific Review
Assigns to IRG/Study Section & IC
Study Section
Submits Application
Evaluates for Scientific Merit
Institute
Evaluates for Program Relevance
Advisory Councils and Boards
Conducts
Research
Allocates Funds
Recommends Action
Institute Director
Takes final action for NIH Director
Normal Timeframe from Submission
to Award for 398 Unsolicited Grants
(PAs & RFAs may be different)
There are normally three overlapping cycles per
year :
JAN
FEB MAR APR MAY JUN
JUL AUG SEP OCT NOV
DEC
JAN FEB MAR
APR
MAY JUN
JUL
Cycle 1
Receipt
Referral
Review
Council
Award
Cycle 2
Receipt
Referral
Review
Council
Award
Cycle 3
Receipt
Referral
Review
Council
Award
NIH’s Electronic Submission
1. Require electronic submission
through Grants.gov for all NIH grant
applications.
2. Transition from the PHS 398
application form to SF424 family of
forms data set.
Grant Writing Tips
• First Steps:
– Broaden your vision
– Seek mentoring and research experience
– Discuss your ideas with successful senior
investigators
– Institutional support for pilot projects?
• Start early. Do not rush!
A Good Idea +
Science2 + Marketing
= Grantsmanship
Art x (pilot data + good idea)
Your end product must:
be clearly written and well structured
be important
be unique
contribute significantly to the field!
Review Criteria
• SIGNIFICANCE: address important problem? Will
scientific knowledge be advanced?
• APPROACH: design and methods appropriate to research
questions? Are potential problem areas addressed?
• INNOVATION: is the project original and innovative?
• INVESTIGATOR: are investigators appropriately trained
and well suited to carry out this work? Does the team bring complementary
and integrated experience to the project?
• ENVIRONMENT: does the scientific environment
contribute to the probability of success? Is there evidence of institutional
support?
Proposal Sections
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Abstract
Specific Aims
Background and Significance
Preliminary Studies
Research Design and Methods
Abstract
• Summarize:
– Nature of the problem
– Long-term objectives
– Need for research
– Specific aims
– Research design and methods
• Must grab the reviewers interest
immediately
Specific Aims
• Clear statement of the problem or question
• Background material to provide context
• Why proposal is innovative, needs to be
done
• Public health significance
• What you plan to do (basics of design and
outcomes)
• Specific aims or hypotheses
Background and Significance
• Problem study will address
• Why a public health concern
• What others have done and why that
wasn’t sufficient
• What you plan to do is different
• How your research will have an impact on
PH
• Why your plan is novel
• Overview of methods and hypotheses
Preliminary Studies
• Description of the team, including prior
collaborations and relevant experience
• Studies conducted by the PI and key
personnel that are relevant
• Pilot data
Research Design and
Methods
• Overview of methods
• Hypotheses
• Study design, including strengths and
advantages, and a discussion of possible
alternatives and reasons for not choosing them
• Subjects (population characteristics,
inclusion/exclusion criteria)
• Informed consent procedures
• Recruitment and attrition information, including a
flow chart
Research Design and
Methods continued
• Sample size and power calculations
• Description of intervention, independent variables, and
control variables
• Description of outcomes
• Procedures, including quality control
• Randomization method
• Study timeline
• Data management and missing values
• Statistical analyses
• Dissemination of results
• Potential limitations and solutions
For More Information
NIH website:
www.nih.gov
NIH Office of
Extramural Research:
http://grants1.nih.gov/
grants/oer.htm
Grant Writing Tips
Summary
• Seek mentoring and research experience
• Discuss your ideas with colleagues
• Know NIH and its priorities
• Discuss your ideas with NIH Program Staff
• Write clearly and concisely with excellent
organization. Strictly follow guidelines.
• Avoid unnecessary complexity
• Have senior colleagues critically read your
application
• Be open to helpful criticism
• Be persistent!
Grant Writing Course
• GMS 6811:
Granting Writing Skills in Epidemiology
and Clinical Research
Instructor: Dr. Shenkman
Fall Semester
Wednesdays, 3-6 PM
1329 Building
Elizabeth A. Shenkman, PhD, Director
Kelli A. Komro, MPH, PhD, Associate Director
Jill Boylston Herndon, PhD
Damon Clark, PhD
I-Chan Huang, PhD
Caprice Knapp, PhD
Mildred M. Maldonado-Molina, PhD
June Nogle, PhD
John Reiss, PhD
Joseph V. Terza, PhD
Alexander C. Wagenaar, PhD
Continuum of Policy Research
Public
Health
Policies
Health Care
Policies
UF Research Mentors
• CRISP: http://crisp.cit.nih.gov/
• ICHP: www.ichp.edu