NIH Grant Writing Tips Kelli A. Komro, MPH, PhD Associate Professor, Department of Epidemiology and Health Policy Research, COM Associate Director, Institute

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

[email protected]@ufl.edu

http://www.ehpr.ufl.edu/

http://www.ehpr.ufl.edu/

http://www.ichp.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

http://crisp.cit.nih.gov/


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 Instituteof Arthritis and

Musculoskeletaland Skin Diseases



National CancerInstitute


National Instituteof Diabetes andDigestive and

Kidney Diseases


Kidney Diseases

National Instituteof Dental andCraniofacial

Research


Research

National Instituteon Drug Abuse


National Instituteof Environmental Health Sciences


National Instituteon Aging


National Instituteof Child Health

and HumanDevelopment



National Institute onDeafness and Other

CommunicationDisorders



National EyeInstitute


National HumanGenome Research

Institute


Institute

National Heart,Lung, and Blood

Institute


Institute

National Instituteof Mental Health


National Instituteof NeurologicalDisorders and

Stroke


Stroke

National Instituteof General

Medical Sciences


Medical Sciences

National Instituteof Nursing Research


National Libraryof Medicine


Center for InformationTechnology


Center for Scientific Review


National Centerfor Complementary

and AlternativeMedicine



National Instituteof Allergy and

Infectious Diseases


Infectious Diseases

National Centerfor ResearchResources


Clinical CenterClinical Center

National Center on Minority Health andHealth Disparities


National Institute of Biomedical Imagingand Bioengineering


National Institutes of Health

Office of the DirectorOffice of the Director










Kidney Diseases


Kidney Diseases


Research


Research


















Institute


Institute


Institute


Institute




Stroke


Stroke


Medical Sciences


Medical Sciences














Infectious Diseases


Infectious Diseases



Clinical CenterClinical Center





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

http://report.nih.gov/strategicplans/index.aspx

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

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


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

http://crisp.cit.nih.gov/


Documents

NIH Grant Writing Tips Kelli A. Komro, MPH, PhD Associate Professor, Department of Epidemiology and Health Policy Research, COM Associate Director, Institute