Indian U'S' Neuroscience Fogarty International Center

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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_at_ufl.edu

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Outline

• 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

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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
• UKs Medical Research Council

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Goal To adapt, implement and evaluate an alcohol
preventive intervention for urban young
adolescents
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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.

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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

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National Institutes of Health
National Institutes of Health
Office of the Director
Office of the Director
Office of the Director
Office of the Director
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
National Institute
of Arthritis and
National Cancer
National Institute
of Child Health
of Arthritis and
National Cancer
National Institute
of Child Health
of Arthritis and
National Cancer
National Institute
of Child Health
of Arthritis and
National Cancer
National Institute
of Child Health
of Allergy and
of Allergy and
on Alcohol Abuse
on Alcohol Abuse
of Allergy and
of Allergy and
on Alcohol Abuse
on Alcohol Abuse
Musculoskeletal
Institute
on Aging
and Human
Musculoskeletal
Institute
on Aging
and Human
Musculoskeletal
Institute
on Aging
and Human
Musculoskeletal
Institute
on Aging
and Human
Infectious Diseases
Infectious Diseases
and Alcoholism
and Alcoholism
Infectious Diseases
Infectious Diseases
and Alcoholism
and Alcoholism
and Skin Diseases
Development
and Skin Diseases
Development
and Skin Diseases
Development
and Skin Diseases
Development
National Institute
National Institute
National Institute on
National Institute
National Institute
National Institute on
National Institute
National Institute
National Institute on
National Institute
National Institute
National Institute on
National Institute
National Institute
National Institute
National Institute
of Diabetes and
of Dental and
National Institute
Deafness and Other
National Eye
of Diabetes and
of Dental and
National Institute
Deafness and Other
National Eye
of Diabetes and
of Dental and
National Institute
Deafness and Other
National Eye
of Diabetes and
of Dental and
National Institute
Deafness and Other
National Eye
of Environmental
of Environmental
of Environmental
of Environmental
Digestive and
Craniofacial
on Drug Abuse
Communication
Institute
Digestive and
Craniofacial
on Drug Abuse
Communication
Institute
Digestive and
Craniofacial
on Drug Abuse
Communication
Institute
Digestive and
Craniofacial
on Drug Abuse
Communication
Institute
Health Sciences
Health Sciences
Health Sciences
Health Sciences
Kidney Diseases
Research
Disorders
Kidney Diseases
Research
Disorders
Kidney Diseases
Research
Disorders
Kidney Diseases
Research
Disorders
National Institute
National Institute
National Institute
National Institute
National Human
National Heart,
National Institute
National Human
National Heart,
National Institute
National Human
National Heart,
National Institute
National Human
National Heart,
National Institute
National Institute
of Neurological
National Institute
National Institute
of Neurological
National Institute
National Institute
of Neurological
National Institute
National Institute
of Neurological
National Institute
Genome Research
Lung, and Blood
of General
Genome Research
Lung, and Blood
of General
Genome Research
Lung, and Blood
of General
Genome Research
Lung, and Blood
of General
of Mental Health
Disorders and
of Nursing Research
of Mental Health
Disorders and
of Nursing Research
of Mental Health
Disorders and
of Nursing Research
of Mental Health
Disorders and
of Nursing Research
Institute
Institute
Medical Sciences
Institute
Institute
Medical Sciences
Institute
Institute
Medical Sciences
Institute
Institute
Medical Sciences
Stroke
Stroke
Stroke
Stroke
National Center
National Center
National Center
National Center
National Center on
National Institute of
National Center on
National Institute of
National Center
National Center
National Center on
National Institute of
National Center on
National Institute of
National Center
National Center
National Library
for Complementary
National Library
for Complementary
National Library
for Complementary
National Library
for Complementary
Minority Health and
Biomedical Imaging
Minority Health and
Biomedical Imaging
for Research
for Research
Minority Health and
Biomedical Imaging
Minority Health and
Biomedical Imaging
for Research
for Research
of Medicine
and Alternative
of Medicine
and Alternative
of Medicine
and Alternative
of Medicine
and Alternative
Health Disparities
and Bioengineering
Health Disparities
and Bioengineering
Resources
Resources
Health Disparities
and Bioengineering
Health Disparities
and Bioengineering
Resources
Resources
Medicine
Medicine
Medicine
Medicine
Center for
Center for
Center for
Center for
Center for
Center for
Center for
Center for
Information
Clinical Center
Information
Clinical Center
Information
Clinical Center
Information
Clinical Center
Scientific Review
Scientific Review
Scientific Review
Scientific Review
Technology
Technology
Technology
Technology
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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

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Institute/Center Strategic Plans

• Institute/Center web sites
• Strategic plans
• http//report.nih.gov/strategicplans/index.aspx
• 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

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National Institute for Child Health and Human
DevelopmentARRA Priorities

• GO Grants, due May 27, 2009
• Developmental Biology and Perinatal Medicine
• Maternal and Child Health
• Contraception, Reproduction and Population
  Research
• Medical Rehabilitation Research
• Challenge Grants, due April 27, 2009
• Behavioral interventions
• Clinical research
• Comparative effectiveness research
• Health disparities
• Etc.
• Supplements to existing NIH grants, various dates

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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

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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)

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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

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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

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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 candidateassurances
  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

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Career Development Plan
R01
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Applications for NIH Research Grants
Grants are normally submitted to NIH in three
ways

• 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 well-defined scientific research area.
  Specific funds are set aside for the projects.

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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/guid
e/index.html
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Dual Review System for NIH Grant Applications
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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.
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Review Criteria
SIGNIFICANCE APPROACH INNOVATION
INVESTIGATOR ENVIRONMENT
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Review Process for A Grant Application Submitted
to CSR, NIH
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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
Review
Council
Receipt
Award
Referral
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NIHs Electronic Submission

• Require electronic submission through Grants.gov
  for all NIH grant applications.
• Transition from the PHS 398 application form to
  SF424 family of forms data set.

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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!

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A Good Idea
Science2 Marketing Art x (pilot data good
idea)
Grantsmanship
Your end product must be clearly written and
well structured be important be
unique contribute significantly to the field!
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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?
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Proposal Sections

• Abstract
• Specific Aims
• Background and Significance
• Preliminary Studies
• Research Design and Methods

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Abstract

• Summarize
• Nature of the problem
• Long-term objectives
• Need for research
• Specific aims
• Research design and methods
• Must grab the reviewers interest immediately

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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

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Background and Significance

• Problem study will address
• Why a public health concern
• What others have done and why that wasnt
  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

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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

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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

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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

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For More Information
NIH Office of Extramural Researchhttp//grants1
.nih.gov/grants/oer.htm
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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!

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Grant Writing Course

• GMS 6811
• Granting Writing Skills in Epidemiology and
  Clinical Research
• Instructor Dr. Shenkman
• Fall Semester
• Wednesdays, 3-6 PM
• 1329 Building

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Elizabeth A. Shenkman, PhD, DirectorKelli A.
Komro, MPH, PhD, Associate DirectorJill Boylston
Herndon, PhDDamon Clark, PhDI-Chan Huang,
PhDCaprice Knapp, PhDMildred M.
Maldonado-Molina, PhDJune Nogle, PhDJohn Reiss,
PhDJoseph V. Terza, PhDAlexander C. Wagenaar,
PhD

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• Continuum of Policy Research

National, state and community policies and
practices
Community orgs and schools
Quality of health care quality of life
Access to health care
Palliative care
Families
Public Health Policies
Health Care Policies
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UF Research Mentors

• CRISP http//crisp.cit.nih.gov/
• ICHP www.ichp.edu