Successful Grant Writing for NIH
Cheryl Anne Boyce, Ph.D.
Chief, Behavioral and Brain Development Branch
Associate Director, Child and Adolescent Research
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
Houston Baker, Ph.D.
Program Director
Imaging Technology Development Branch
Cancer Imaging Program
National Cancer Institute
“Anatomy” of Grant Process
Program Staff
Researcher
Revision
Collaborators
Program
Announcement
or RFA
Idea
Institution
Grant Application
(R01, R03, R21,
K01, K08, etc.)
$
Program Staff
National
Advisory
Council
CSR
Referral
and Review
Grant 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 Funded?
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Impact Score—Scientific merit
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Program considerations
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Availability of funds
NIH Award Mechanisms
Grants
Numerous grant mechanisms
R01s, R21s, R03s, K99’s, etc.
Multi-project grants- P01, P30, P41, P50, etc.
Investigator initiated (PA or PAR) or solicited (RFA)
Cooperative agreements
“U” grants, used for most clinical trial and other networks
Substantial NIH staff involvement
Solicited—Request for Applications (RFA)
Contracts
N01s
Solicited—Request for Proposals (RFP)
Three Ways to Work with an IC
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Submit an application for a grant or contract
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Indirectly through someone who has funding
from the IC
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Apply for grant funding for your research project grant at
any time or for specific opportunities (PA, PAR, PAS)
Apply to a specific competition for grant set-asides (RFA)
or a specific contract competition (RFP, BAA)
Collaborate with an extramural awardee as a subcontractor
Collaborate with our Intramural Research Program through
material transfer agreements, etc.
Gain access to IC sponsored resources
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Get help and in-kind materials from our specimen
resources, etc.
Applying for Grants (e-Submission)
Grant Submission Dates
http://grants.nih.gov/grants/funding/submissionschedule.htm#elec
Electronic Submission
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Most NIH grant applications require electronic submission via
http://Grants.Gov
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eRA Commons: secure web-based information exchange
between NIH and applicant organization (PI and Business
Official) http://commons.era.nih.gov
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Applicant business office and PI must establish personal eRA
Commons accounts to track review progress and to retrieve
scores and summary statements
You must register for e-submission
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Register on Grants.gov
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(may take 4-8 weeks)
Register with US CCR (Central Contractor Registration)
Obtain DUNS number (Data Universal Numbering System)
Obtain Grants.gov credentials
Assign an AOR to submit grants (Authorized Organizational
Representative); SO (Signing Official)
Non-US organization: may require registration with North
Atlantic Treaty Organization Commercial and Government
Entity (NCAGE)
Register on eRA Commons
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Both applicant and organization must register
One-time registration
Enables you to receive and transmit application or information
electronically
Applying for an NIH Grant
“I don’t really care about that administrative stuff!”
But it is IMPORTANT:
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To understand how NIH works!
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Network with NIH staff
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Easy to disengage and only focus on the lab
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”?
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NIH fosters research independence of new
investigators
Definition: Has not previously served as PI on
any NIH grant
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Except R03, R15, R21, R42, R43 or mentored K awards
Gets special consideration during peer review
and IC funding decisions
See web site for details:
grants1.nih.gov/grants/new_investigators
Are you an Early Stage Investigator (ESI)?
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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 consideration 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?
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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 Criteria
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Review of applications based on NIH standard
review criteria
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Significance
Investigators
Innovation
Approach
Environment
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Also initiative specific review criteria, when
applicable
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Different criteria for training related applications
Peer 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: Process
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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:
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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
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Does it address an important problem?
Will scientific knowledge be advanced?
Does it build upon or expand current
knowledge?
Is it feasible …
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to implement?
to investigate?
Good Grantsmanship
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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
Good Grantsmanship
What’s a Concept Paper?
Facilitates productive discussion with Program Official
 Study Goals
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Problem/Background
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What hypotheses will you test?
Design/Analysis
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Why this is important to the field?
Research Question
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Why does this topic need study?
Significance
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You want support from which IC to do what?
What study design and statistical approach do you propose?
Team
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Who will be the key participants and collaborators?
Good Grantsmanship
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Collaborate with other investigators
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“Team Science” is the new direction
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Fill gaps in your expertise and training
Add critical skills to your team
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
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Ask a colleague to review your draft
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Your draft reviewers need to understand
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Ask a colleague who does not already know
what you intend to do
Ask a colleague who is not your best friend
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 Presentation
3 Simple Steps:
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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
Alignment of Application Format with
Scored Review Criteria
Scored Review Criteria
Significance
Application
Research Strategy
a. Significance
Investigator(s)
Biosketch
Personal Statement
Innovation
Research Strategy
b. Innovation
Approach
Research Strategy
c. 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)
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Personal Statement – why experience and
qualifications make the applicant particularly
well-suited for role in the project
Publications limited to 15
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5 most recent
5 best
5 most relevant to the application
Restructured Research Plan:
Significance, Innovation, Approach
Previous Application
New Application
Background and
Significance
Research Design and
Methods
Preliminary
Studies/Progress
Report
Research Strategy
a. Significance
b. Innovation
c. Approach
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Preliminary Studies
for New Applications
Progress Report for
Renewal/Revision
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
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Title
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Abstract
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Capture essence of goals and objectives
Present your project Concisely
State significance Clearly
State Hypotheses, Research Problem, Solution
Methods and Rationale
Write direct, active text: Read aloud.
 Snooze? Fix!
Good Presentation
Organize the Research Strategy to answer 4
essential questions:
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What do you intend to do?
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Why is the work important?
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What has already been done?
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How are you going to do the work?
Good Presentation
Address Scored Review Criteria
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Significance: Does the study address an important
problem? How will scientific knowledge be advanced?
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Investigator: Is the investigator appropriately trained?
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Innovation: Are there novel concepts or approaches? Are
the aims original and innovative?
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Approach: Are design and methods well-developed and
appropriate? Are problem areas addressed?
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Environment: Does the scientific environment contribute to
the probability of success? Are there unique features of the
scientific environment?
Good Presentation
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Provide well-focused research plan
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Keep specific aims simple … and specific
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Link hypotheses to specific aims
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Explain method chosen to test every
hypothesis
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Don’t wander from the main theme
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A conceptual model can clarify ideas
Good Presentation
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Be realistic … not overly ambitious
Discuss potential problem areas
Discuss possible solutions
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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
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Be well organized and clear
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Use logical transitions between sections
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Add section headings -- major and minor
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Make tables and figures easy to view
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Eliminate all mispeelings and type-O’s
Good Presentation
Prepare a reviewer-friendly application
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Be well organized and clear
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Use logical transitions between sections
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Add section headings -- major and minor
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Make tables and figures easy to view
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Eliminate all misspellings and typo’s
Good Review
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
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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
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Get reviewers on your side!
Good Luck
Results from:
 Good Ideas
 Good Grantsmanship
 Good Presentation
 Good Review
Elements of an Outstanding
Grant Application
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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
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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)
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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
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Not discussing literature that is contrary to your ideas
Not discussing strengths and limitations of your datadon’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)
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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
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The most critical page in the application
It is a one page summary of the application
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Describe Overall Impact expected
Why is this problem significant?
What are the exciting preliminary data?
What hypotheses do the data support?
Simple list of your Aims is good
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Be general
Avoid long (laundry) list of things you are going to do
2-3 Specific Aims is sufficient (Focus: must fit together)
Research Strategy
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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
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Show primary data for critical methods
Make figures or tables readable
Progress Report- for renewals
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Restate Aims (avoid laundry list)
Publication list MUST be very strong. No productivity- no grant
Convince reviewer that you can do what you propose
Approach (Methods)
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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
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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!!
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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
www.nih.gov
grants1.nih.gov/grants/oer.htm
NIH OER
NIH Guide for Grants and Contracts
NIH Guide for Grants and Contracts
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Official publication listing NIH funding
opportunities and policy notices
Published weekly
List grants and contracts
 Request for Applications (RFA)
 Program Announcements (PA) (& PAR, PAS)
 Request for Proposals (RFP)
Research Portfolio Online
Reporting Tool (RePORT)
http://report.nih.gov/index.aspx
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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:
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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/