Post on 18-Jan-2016
NIH Grant Writing TipsNIH Grant Writing TipsKelli A. Komro, MPH, PhDKelli A. Komro, MPH, PhD
Associate Professor, Department of Epidemiology Associate Professor, Department of Epidemiology and Health Policy Research, COMand Health Policy Research, COM
Associate Director, Institute for Child Health PolicyAssociate Director, Institute for Child Health Policy
www.ehpr.ufl.edu
www.ichp.ufl.edu
komro@ufl.edukomro@ufl.edu
OutlineOutline
• 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 BackgroundResearch BackgroundResearch ExperienceResearch Experience
• PhD in Epidemiology, 1994, University of MinnesotaPhD in Epidemiology, 1994, University of Minnesota
• Associate Professor, EHPR and Associate Director, ICHPAssociate Professor, EHPR and Associate Director, ICHP
• $29M in grant funding, mostly NIH$29M in grant funding, mostly NIH
• Child & adolescent health; community-wide preventive Child & adolescent health; community-wide preventive interventions; group-randomized trialsinterventions; group-randomized trials
• Mentor graduate students and junior facultyMentor graduate students and junior faculty
Grant Review ExperienceGrant Review Experience
• NIH grant reviews NIH grant reviews
• UK’s Medical Research CouncilUK’s Medical Research Council
Goal: To adapt, implement and evaluate an alcohol Goal: To adapt, implement and evaluate an alcohol preventive intervention for urban young adolescentspreventive intervention for urban young adolescents
U.S. Department of Health and Human Services
Administration forChildren and Families
(ACF)
Administration forChildren and Families
(ACF)
Food and DrugAdministration
(FDA)
Food and DrugAdministration
(FDA)
Health Resourcesand Services
Administration(HRSA)
Health Resourcesand Services
Administration(HRSA)
TheSecretary
Deputy Secretary
TheSecretary
Deputy Secretary
Administration onAging(AoA)
Administration onAging(AoA)
Centers for Medicare and Medicaid Services
(CMS)
Centers for Medicare and Medicaid Services
(CMS)
Indian HealthServices
(IHS)
Indian HealthServices
(IHS)
Centers for Disease Controland Prevention
(CDC)
Centers for Disease Controland Prevention
(CDC)
Substance Abuse andMental Health Services
Administration(SAMHSA)
Substance Abuse andMental Health Services
Administration(SAMHSA)
Program SupportCenter(PSC)
Program SupportCenter(PSC)
Agency for ToxicSubstances andDisease Registry
(ATSDR)
Agency for ToxicSubstances andDisease Registry
(ATSDR)
Agency for Health Care Policy
and Research(AHCPR)
Agency for Health Care Policy
and Research(AHCPR)
National Institutesof Health
(NIH)
National Institutesof Health
(NIH)
MissionNIH conducts and supports basic, applied,
clinical and health services research to understand the processes underlying
human health and to acquire newknowledge to help prevent, diagnose, and
treat human diseases and disabilities.
National Institutes of HealthNational Institutes of Health
NIH FundingNIH 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%
Office of the DirectorOffice of the Director
National Instituteon Alcohol Abuseand Alcoholism
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis and
Musculoskeletaland Skin Diseases
National Instituteof Arthritis and
Musculoskeletaland Skin Diseases
National CancerInstitute
National CancerInstitute
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Instituteof Environmental Health Sciences
National Instituteon Aging
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Instituteof Child Health
and HumanDevelopment
National Institute onDeafness and Other
CommunicationDisorders
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National EyeInstitute
National HumanGenome Research
Institute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Instituteof Nursing Research
National Libraryof Medicine
National Libraryof Medicine
Center for InformationTechnology
Center for InformationTechnology
Center for Scientific Review
Center for Scientific Review
National Centerfor Complementary
and AlternativeMedicine
National Centerfor Complementary
and AlternativeMedicine
National Instituteof Allergy and
Infectious Diseases
National Instituteof Allergy and
Infectious Diseases
National Centerfor ResearchResources
National Centerfor ResearchResources
Clinical CenterClinical Center
National Center on Minority Health andHealth Disparities
National Center on Minority Health andHealth Disparities
National Institute of Biomedical Imagingand Bioengineering
National Institute of Biomedical Imagingand Bioengineering
National Institutes of Health
Office of the DirectorOffice of the Director
National Instituteon Alcohol Abuseand Alcoholism
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis and
Musculoskeletaland Skin Diseases
National Instituteof Arthritis and
Musculoskeletaland Skin Diseases
National CancerInstitute
National CancerInstitute
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Instituteof Environmental Health Sciences
National Instituteon Aging
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Instituteof Child Health
and HumanDevelopment
National Institute onDeafness and Other
CommunicationDisorders
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National EyeInstitute
National HumanGenome Research
Institute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Instituteof Nursing Research
National Libraryof Medicine
National Libraryof Medicine
Center for InformationTechnology
Center for InformationTechnology
Center for Scientific Review
Center for Scientific Review
National Centerfor Complementary
and AlternativeMedicine
National Centerfor Complementary
and AlternativeMedicine
National Instituteof Allergy and
Infectious Diseases
National Instituteof Allergy and
Infectious Diseases
National Centerfor ResearchResources
National Centerfor ResearchResources
Clinical CenterClinical Center
National Center on Minority Health andHealth Disparities
National Center on Minority Health andHealth Disparities
National Institute of Biomedical Imagingand Bioengineering
National Institute of Biomedical Imagingand Bioengineering
National Institutes of Health National Institutes of Health
Fogarty International
Center
A Typical Institute/Center
Office of the ICOffice of the ICDirectorDirector
NationalNationalAdvisoryAdvisoryCouncilCouncil
Board ofBoard ofScientificScientific
CounselorsCounselors
ExtramuralExtramural
ScientificScientificProgramsPrograms
GrantsGrants ContractsContracts
IntramuralIntramural
LaboratoryLaboratoryStudiesStudies
ClinicalClinicalStudiesStudies
Institute/Center Program OfficersInstitute/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 PlansInstitute/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
National Institute for Child Health National Institute for Child Health and Human Developmentand Human Development
ARRA PrioritiesARRA 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
Most Common NIH Grant TypesMost 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 AwardsMentored 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 AwardsFeatures 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 Review Criteria for Mentored Career Development AwardsDevelopment 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 Review Criteria for Mentored Career Development AwardsDevelopment 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 PlanCareer Development Plan
YesYes
Do I have pilot data?
NoNo
NoNo
Apply for R03/ B/START
Do I need more training or changing career emphasis?
Institutional Pre-Doctoral Fellowship-T32
Pre-Doctoral Fellowship-F31
Post-Doctoral Fellowship-F32
Institutional Post-Doctoral Fellowship-T32
R01
YesYes
Apply for Mentored K
• 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.
Applications for NIH Research GrantsApplications for NIH Research Grants
Grants are normally submitted to NIH in three ways:
NIH Guide for Grants and ContractsNIH 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 Dual Review System for NIH Grant ApplicationsNIH Grant Applications
• Assesses Quality of SRG Review of Grant Applications
• Makes Recommendation to Institute Staff on Funding
• Evaluates Program Priorities and Relevance
• Advises on Policy
Second Level of Review: Institute or Center Council
• Provides Initial Scientific Merit Review of Grant Applications
• Rates Applications and makes Recommendations for Appropriate Level of Support and Duration of Award
Scientific Review Group (SRG)
NIH Peer Review ProcessNIH 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 CriteriaReview Criteria
• SIGNIFICANCE• APPROACH• INNOVATION• INVESTIGATOR• ENVIRONMENT
ResearchGrant
Application
School or OtherResearch Center
National Institutes of Health
Center for Scientific Review
InitiatesResearchIdea
ConductsResearch
Submits Application
Allocates Funds
Assigns to IRG/Study Section & IC
Evaluates for Scientific Merit
Evaluates for Program Relevance
Advisory Councils and Boards
Institute Director
Recommends Action
Takes final action for NIH Director
Institute
Study Section
Review Process for A Grant Application Review Process for A Grant Application Submitted to CSR, NIHSubmitted to CSR, NIH
Normal Timeframe from Submission Normal Timeframe from Submission to Award for 398 Unsolicited Grantsto Award for 398 Unsolicited Grants
(PAs & RFAs may be different) (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
Review Council
Cycle 1Receipt
Referral Award
Review Council
Cycle 3ReceiptReferral Award
Review CouncilCycle 2
ReceiptAwardReferral
NIH’s Electronic SubmissionNIH’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 TipsGrant 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 +A Good Idea +
Science2 + Marketing Art x (pilot data + good idea)
= Grantsmanship
Your end product must:be clearly written and well structuredbe importantbe uniquecontribute significantly to the field!
Review CriteriaReview 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 SectionsProposal Sections
• Abstract
• Specific Aims
• Background and Significance
• Preliminary Studies
• Research Design and Methods
AbstractAbstract
• Summarize:– Nature of the problem– Long-term objectives– Need for research– Specific aims– Research design and methods
• Must grab the reviewers interest immediately
Specific AimsSpecific 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 SignificanceBackground 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 StudiesPreliminary 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 Research Design and MethodsMethods
• 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 Research Design and Methods Methods continuedcontinued
• 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
NIH website: www.nih.gov
For More InformationFor More Information
NIH Office of Extramural Research:http://grants1.nih.gov/
grants/oer.htm
• 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 TipsGrant Writing TipsSummarySummary
Grant Writing CourseGrant 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, DirectorElizabeth A. Shenkman, PhD, DirectorKelli A. Komro, MPH, PhD, Associate DirectorKelli A. Komro, MPH, PhD, Associate Director
Jill Boylston Herndon, PhDJill Boylston Herndon, PhDDamon Clark, PhDDamon Clark, PhDI-Chan Huang, PhDI-Chan Huang, PhDCaprice Knapp, PhDCaprice Knapp, PhD
Mildred M. Maldonado-Molina, PhDMildred M. Maldonado-Molina, PhDJune Nogle, PhDJune Nogle, PhDJohn Reiss, PhDJohn Reiss, PhD
Joseph V. Terza, PhDJoseph V. Terza, PhDAlexander C. Wagenaar, PhDAlexander C. Wagenaar, PhD
Continuum of Policy Research
Public Health Policies
Health Care Policies
Natio
nal,
stat
e an
d
com
mun
ity p
olic
ies
and
prac
tices
Comm
unity
org
s
and
scho
ols
Fam
ilies
Acces
s to
hea
lth
care Qua
lity
of h
ealth
care
& q
ualit
y of
life Pal
liativ
e ca
re
UF Research MentorsUF Research Mentors
• CRISP: http://crisp.cit.nih.gov/
• ICHP: www.ichp.edu