Successful Grant Writing for NIH

Milton J. Hernández, Ph.D.

Director

Division of Loan Repayment

OEP, OER, OD

National Institutes of Health

Bethesda, MD 20892

mh35c@nih.gov

Michael A. Sesma, Ph.D.

Program Official

Research Training and Career Development Program

Division of Developmental Translational Research

NIMH/NIH

Bethesda, MD. 20892

ms265g@nih.gov

““Anatomy” of Grant ProcessAnatomy” of Grant Process““Anatomy” of Grant ProcessAnatomy” of Grant Process

Program StaffProgram StaffProgram StaffProgram Staff ProgramProgramAnnouncementAnnouncement

or RFAor RFA

ProgramProgramAnnouncementAnnouncement

or RFAor RFA

Grant ApplicationGrant Application(R01, R03, R21,(R01, R03, R21,K01, K08, etc.)K01, K08, etc.)

Grant ApplicationGrant Application(R01, R03, R21,(R01, R03, R21,K01, K08, etc.)K01, K08, etc.)

NationalNationalAdvisoryAdvisoryCouncilCouncil

NationalNationalAdvisoryAdvisoryCouncilCouncil

Program Staff Program Staff Program Staff Program Staff

$$

Rev

isio

nR

evis

ion

Rev

isio

nR

evis

ion

ResearcherResearcher

IdeaIdeaInstitutionInstitution

ResearcherResearcher

IdeaIdeaInstitutionInstitution

CSRCSRReferralReferral

and Review and Review

CSRCSRReferralReferral

and Review and Review

CollaboratorsCollaboratorsCollaboratorsCollaborators

Grant Writing for SuccessGrant Writing for Success

Writing the Application

• Start early• Seek advice from colleagues• Start with a good idea• Talk to your NIH Program Official(s)• Use the NIH webpage (www.nih.gov)• Remember review criteria• Follow instructions carefully

Transition to Electronic Submission (http://era.nih.gov/ElectronicReceipt/)

What Determines Which Grants Are What Determines Which Grants Are Funded?Funded?

• Scientific merit - Priority ScoreScientific merit - Priority Score

• Program considerationsProgram considerations

• Availability of fundsAvailability of funds

NIH Award MechanismsNIH Award Mechanisms

GrantsNumerous grant mechanismsR01s, R21s, R03s, K99’s, etc. Multi-project grants- PsInvestigator initiated (PA) or solicited (RFA)

Cooperative agreements“U” grants, used for complex studies, most clinical trial networksSubstantial NIH staff involvementSolicited (RFA)

Contracts N01sSolicited (RFP)

Three Ways to Work with an ICThree Ways to Work with an IC

Submit an application for a grant or contract Apply for your own funding for a research project grant at

any time Apply to a specific competition for grant set-asides (RFA)

or a specific contract competition (RFP, BAA) Indirectly through someone who has funding

from the IC Collaborate with an extramural awardee as a sub-recipient Collaborate with our Intramural Research Program through

material transfer agreements, etc. Gain access to IC sponsored resources

Get help and in-kind materials from our specimen resources, etc.

Applying for Grants (e-Submission)

Grant Submission DatesGrant Submission Dateshttp://grants.nih.gov/grants/funding/submissionschedule.htm#elec

Electronic SubmissionElectronic Submission

Most types of NIH grant applications are submitted electronically via Grants.Gov

eRA Commons is a web-based system for secure information exchange with applicants and applicant organizations (http://commons.era.nih.gov/)

Applicants must establish personal eRA Commons accounts to track review progress and to retrieve scores and summary statements

You must register for e-submission

Register on Grants.gov Register with US CCR Obtain DUNS number Obtain Grants.gov credentials Assign an AOR to submit grants Non-US institution or organization may require additional

registration with a North Atlantic Treaty Organization Commercial and Government Entity (NCAGE)

Register on eRA Commons Both applicant and organization must register One-time registration Enables you to receive and transmit information or application

electronically This process may take 4-8 weeks

Applying for an NIH Grant

“I don’t really care about that administrative stuff!”But it is IMPORTANT: To understand how NIH works!

Easy to disengage and only focus on the lab Network with NIH staff

Talk to us at meetings, on the phone, by email The squeaky wheel gets the oil If I don’t know you, how can I help you?

Understand how NIH peer review works Learn what works and what doesn’t in peer review

AND funding

Are You a “New Investigator”?Are You a “New Investigator”? NIH fosters research independence of early

career investigators Definition: Has not previously served as PI on

any PHS grant Except for R03, R15, R21 or mentored K awards

Get special considerations during peer review and IC funding decisions

Resource web site with further information

grants1.nih.gov/grants/new_investigators

Are you an Early Stage Investigator (ESI)? NIH fosters research independence of early career

investigators Definition: Has completed his or her terminal

research degree or medical residency—whichever date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grant

Get special considerations during peer review and IC funding decisions

Where are applications reviewed?

CSR

•Study Sections

INSTITUTES

•Scientific Review Groups•Contract Review Ctees.

•Research Project Grants (R01s)•AREA Grants (R15s)•Fellowships (F32s & F31s)•SBIRs•Shared Instrumentation Grants•Small Grants (R03s)•Exploratory/Developmental Grant (R21s)

•Program Project Grants (P01s)•Center Grants (P30s)•Training Grants (T32s)•K Grants•RFAs (some of which will be for R01s)•Contracts

Who are the Peer Reviewers?

Established Investigators - few assistant professors

Demonstrated scientific expertise Mature judgment Breadth of perspective Impartiality Adequate representation of women and minority

scientists Diversity of expertises represented

Peer Review: Evaluation CriteriaPeer Review: Evaluation Criteria

Review of applications based on NIH standard review criteria Significance Approach Innovation Investigator Environment

Also initiative specific review criteria, when applicable

Different criteria for training related applications

Peer Review: New NIH Scoring SystemPeer Review: New NIH Scoring System

Score Descriptor Additional Guidance on Strengths/Weaknesses

1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with negligible weaknesses

3 Excellent Very strong with only some minor weaknesses

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weaknesses

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

Peer Review: ProcessPeer Review: Process

The SRO prepares an order of review that clusters New Investigator (NI) applications, Early Stage Investigator applications (ESIs) and clinical applications if feasible.

NI and ESI applications are identified for reviewers so there can be appropriate review in context of career stage.

Expectations of preliminary data and publication track record less than for established investigators.

MOST IMPORTANT SLIDE!Most common reasons for not receiving funds: Lack of new or original ideas Diffuse, superficial or unfocused research plan Lack of knowledge of published relevant work Lack of experience in the essential methodology Uncertainty concerning the future directions Questionable reasoning in experimental approach Absence of acceptable scientific rationale Unrealistically large amount of work Lack of sufficient experimental detail Uncritical approach

Formula for Successful Applications

Start with a Good Idea

Does it address an important problem? Will scientific knowledge be advanced? Does it build upon or expand current

knowledge? Is it feasible …

to implement? to investigate?

Good Grantsmanship

Contact NIH program staff early Assess IC interest & “goodness of fit” Are there related FOAs? Searching web sites is good start … but

follow up with personal contact Send a 2 – 3 page concept paper to a

program contact

Facilitates productive discussion with Program Official Study Goals

You want support from which IC to do what? Problem/Background

Why does this topic need study? Significance

Why this is important to the field? Research Question

What hypotheses will you test? Design/Analysis

What study design and statistical approach do you propose? Team

Who will be the key participants and collaborators?

What’s a Concept Paper?

Good Grantsmanship

Collaborate with other investigators Fill gaps in your expertise and training Add critical skills to your team

“Team Science” is the new direction Support for multidisciplinary research projects Consider the Multiple-PI Model

Talk to NIH program contact if the project involves multiple PIs

grants1.nih.gov/grants/multi_pi

Good Grantsmanship

Ask a colleague to review your draft Ask a colleague who does not already know

what you intend to do Ask a colleague who is not your best friend

Your draft reviewers need to understand What you intend to do Why you believe it is important to do Exactly how you are going to do it

Leave enough time to make revisions

Good Grantsmanship

Good Presentation

Read the application instructions carefully Read the application instructions carefully Don’t forget …

... read the application instructions carefully

http://enhancing-peer-review.nih.gov/restructured_applications.html

3 Simple Steps:

Alignment of Application Format with Review Criteria

Core Review Criteria Application

Significance Research Strategya. Significance

Investigator(s) BiosketchPersonal Statement

Innovation Research Strategyb. Innovation

Approach Research Strategyc. Approach

Environment Resources Environment

Application Changes

Changes to three parts of application: Biographical sketch Research Plan Resources

Changes in page limits and format

Application Changes: Biographical Sketch (4 pages) Personal Statement – why experience and

qualifications make the applicant particularly well-suited for role in the project

Publications limited to 15 5 most recent 5 best 5 most relevant to the application

Restructured Research Plan:Significance, Innovation, Approach

Review Criteria now aligned with Application Format

Application Changes: Resources

Facilities and Other Resources (in 424 part of the R&R Other Project Information; in 398

the Resources Format Page)

Environment - New instruction to address how scientific environment will contribute to probability of success, unique features of environment, etc. For ESIs, provide description of institutional investment in success of the investigator.

Good Presentation

Title Captures the essence of goals and objectives

Abstract Concise presentation of the project Statement of significance Hypotheses and research questions Methods and analyses

Some reviewers may see only these

Good Presentation

Organize the Research Strategy to answer 4 essential questions:

What do you intend to do?

Why is the work important?

What has already been done?

How are you going to do the work?

Good Presentation

Address the Core review criteria Significance: Does the study address an important

problem? How will scientific knowledge be advanced?

Approach: Are design and methods well-developed and appropriate? Are problem areas addressed?

Innovation: Are there novel concepts or approaches? Are the aims original and innovative?

Investigator: Is the investigator appropriately trained?

Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

Good Presentation

Provide well-focused research plan Keep specific aims simple … and specific Link hypotheses to specific aims Explain method chosen to test every

hypothesis Don’t wander from the main theme A conceptual model can clarify ideas

Be realistic … not overly ambitious Discuss potential problem areas Discuss possible solutions

Explain rationale for your decisions Be explicit Reviewers cannot read your mind …

Don’t assume they know what you intend

Good Presentation

Prepare a reviewer-friendly application

Be well organized and clear

Use logical transitions between sections

Add section headings -- major and minor

Make tables and figures easy to view

Eliminate all mispeelings and type-O’s

Good Presentation

Prepare a reviewer-friendly application

Be well organized and clear

Use logical transitions between sections

Add section headings -- major and minor

Make tables and figures easy to view

Eliminate all misspellings and typo’s

Good Presentation

Get to the right review group Make sure your application goes to the right

review group* Title, abstract, specific aims all point to the main

goals of your project Include a Cover Letter

suggest IC and review group assignment* Outline key expertise needed for appropriate review do not name specific reviewers

* Consult with Program Officer

Good Review

Good Presentation will keep your reviewers happy

Reviewers often work late at night Help them stay alert and interested Make your application easy to read and easy

to understand Convince reviewers to advocate for your idea

Get reviewers on your side!

Good Review

Good Luck

Results from: Good Ideas Good Grantsmanship Good Presentation Good Review

Elements of an Outstanding Grant Application

New or original ideas Pilot data (essential for R01/ less critical for

Fs and Ks) Focused, incisive research plan Knowledge of published relevant work Experience in the essential methodology Future directions and contingency plans

Writing an R01 (Regular Research Grant)Directly from a senior reviewer Write Specific Aims section and discuss with mentor or

an NIH grantee Give yourself four weeks to write first draft Full draft to mentor one month before submission date

Read and follow the instructions (electronic 424) Prepare budget with budget person

Write for a general scientific audience Simple is better Repetition is good

Writing an R01 (cont’d)

You must have simple testable hypothesis that is supported by preliminary data Study Sections are conservative No preliminary data = No award

Demonstrate medical significance Rationale, limitations of methods, controls, and back-up

plans are critical Details of methods are unimportant (boring) but make sure

the reviewers know you know the methods and say so Get collaborators and consultants- strong letters

R01 Common Errors

Not discussing literature that is contrary to your ideas Not discussing strengths and limitations of your data-

don’t let reviewer do it for you! Proposing too much for 3 or 5 years Common criticisms:

“This Specific Aim could serve as an entire grant in and of itself”

“Research is unfocused” “Study is overambitious” “Not clear investigator has needed experience”

R01 Common Errors (cont’d)

Lack of relationship to disease Methodology over Biology is not good Descriptive vs Hypothesis-driven

“Looking at” (bad) vs “testing” (good) “Fishing expedition” (bad)

No biostatistical support Sample size (power) calculations for animal or human

studies Inadequate control group

Specific Aims

The most critical page in the application It is a one page summary of the application

Why is this problem significant? What is the exciting preliminary data? What are the hypothesis supported by the data?

Simple list of your Aims is good Be general Avoid long (laundry) list of things you are going to do 2-3 Specific Aims is sufficient

Research Strategy

Assume you are not writing for an expert Emphasize general medical importance and then specific

importance of your topic Avoid jargon Discuss controversies in the area Avoid selective citation of the literature Make your story interesting- make the reviewer want to read

more! Correct English, grammar, and attention to typographical

errors is important. Reviewers like a “pretty” application.

Preliminary Data

Show primary data for critical methods About 10-15 readable figures or tables Progress Report- for renewals

Restate Aims (avoid laundry list) Publication list MUST be very strong. No production- no grant

Convince reviewer that you can do what you propose

Approach (Methods)

Do you have the right tools and experience? Is this the right model system/preparation? Are there adequate controls? Are you discussing the pitfalls and

alternatives? Avoid details (volumes, components of buffers) Show a time line - reviewers like them

Response to Critiques - When you resubmit an application

You have 1 page to explain how you revised the application in response to issues identified by the reviewers - make it easy for reviewer to find your “answers”

Misunderstandings are your fault- if they missed a key fact in a figure or table, maybe it wasn’t clear enough

Be diplomatic and positive (most reviewer’s comments are good). Don’t argue with reviewers.

Avoid tone that says “You (the reviewer) don’t know anything about this area”

Address every single criticism Avoid overstating your data

Don’t give up!!

Initial failure is common Understand which parts of the application process are

under your control Learn from a failed submission and succeed - majority do

Study criticisms in Summary Statement Discuss with program to decide if problems are

repairable Attend diligently to each criticism Keep a positive tone and attitude

“Highly improved” amended applications tend to do well.

www.nih.gov

grants1.nih.gov/grants/oer.htm

NIH OERNIH Guide for Grants and Contracts

NIH Guide for Grants and Contracts Official publication listing NIH funding and policy

notices Published weekly List grants and contracts

Request for Applications (RFA) Program Announcements (PA) Request for Proposals (RFP)

Research Portfolio Online Reporting Tool (RePORT) http://report.nih.gov/index.aspx A Searchable database of federally supported

biomedical research -- Replaces C.R.I.S.P. Access reports, data, analyses, expenditures,

results of NIH supported research activities Identify, Analyze IC(s) research portfolios,

funding patterns, funded investigators:• Identify areas with many or few funded projects• Identify NIH-funded investigators and their research• Identify potential mentors/collaborators

grants1.nih.gov/grants/grant_tips.htm

www.niaid.nih.gov/ncn/grants/