1. 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 1

2. “Anatomy” of Grant Process
Researcher
Idea
Institution
Program Staff
Program
Announcement
or RFA
Collaborators
Grant Application
(R01, R03, R21,
K01, K08, etc.)
Revision $
National
Advisory
Council
CSR
Referral
and Review
Program Staff 2

3. 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 (
Remember review criteria
Follow instructions carefully
Transition to Electronic Submission ( 3 3

4. What Determines Which Grants Are Funded?
Impact Score—Scientific merit
Program considerations
Availability of funds 4

5. NIH Award Mechanisms Grants Cooperative agreements Contracts
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)

6. Three Ways to Work with an IC
Submit an application for a grant or contract
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)
Indirectly through someone who has funding from the IC
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
Get help and in-kind materials from our specimen resources, etc.

7. Applying for Grants (e-Submission)

8. Grant Submission Dates http://grants. nih

9. Electronic Submission
Most NIH grant applications require electronic submission via
eRA Commons: secure web-based information exchange between NIH and applicant organization (PI and Business Official)
Applicant business office and PI must establish personal eRA Commons accounts to track review progress and to retrieve scores and summary statements
eRA: electronic Research Administration

10. You must register for e-submission
Register on Grants.gov (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
Both applicant and organization must register
One-time registration
Enables you to receive and transmit application or information electronically

11. Applying for an NIH Grant

12. “I don’t really care about that administrative stuff
“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
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

13. Are You a “New Investigator”?
NIH fosters research independence of new investigators
Definition: Has not previously served as PI on any NIH grant
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 13

14. 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 consideration during peer review and IC funding decisions

15. Where are applications reviewed?
CSR
Study Sections
Research Project Grants (R01s)
AREA Grants (R15s)
Fellowships (F32s & F31s)
SBIRs
Shared Instrumentation Grants
Small Grants (R03s)
Exploratory/Developmental Grant (R21s)
INSTITUTES
Scientific Review Groups
Contract Review Ctees.
Program Project Grants (P01s)
Center Grants (P30s)
Training Grants (T32s)
K Grants
RFAs (some of which will be for R01s)
Contracts

16. 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
The typical reviewer:
Associate Professor or Professor with active publication record and history of NIH grant support
Record of prior participation on IRGs preferred.
Conflicts of interest are carefully assessed.
Specific assignments selected based upon SRA evaluation of reviewer experience and reviewer designated level of comfort with specific subject areas.
If we don’t have the right expertise on the panel, we get it (ad hoc, telephone, write-in)

17. Peer Review: Evaluation Criteria
Review of applications based on NIH standard review criteria
Significance
Investigators
Innovation
Approach
Environment
Also initiative specific review criteria, when applicable
Different criteria for training related applications

18. 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

19. Peer 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.

20. 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
Common reviewer criticisms:
The work proposed is not hypothesis driven / is a fishing expedition.
The data generated will be correlative at best, and will offer no progress in understanding mechanisms.
The proposal is overly ambitious and unrealistic.
The investigator has a lack of recent research productivity.
There are not adequate preliminary data to support an investment of this magnitude in the project proposed.

21. Formula for Successful Applications

22. 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?

23. 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

24. Good Grantsmanship What’s a Concept Paper?
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?

25. Good Grantsmanship grants1.nih.gov/grants/multi_pi
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

26. 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

27. Good Presentation 3 Simple Steps:
Read the application instructions carefully
Don’t forget …
... read the application instructions carefully

28. Alignment of Application Format with Scored Review Criteria
Significance
Research Strategy
a. Significance
Investigator(s)
Biosketch
Personal Statement
Innovation
b. Innovation
Approach
c. Approach
Environment
Resources

29. Application Changes Changes to three parts of application:
Biographical sketch
Research Plan
Resources
Changes in page limits and format

30. 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

31. Restructured Research Plan: Significance, Innovation, Approach
Previous Application
New Application
Background and Significance
Research Strategy
Significance
Innovation
Approach
Preliminary Studies for New Applications
Progress Report for Renewal/Revision
Research Design and
Methods
Preliminary Studies/Progress Report
Review Criteria now aligned with Application Format

32. 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.

33. Good Presentation Title Abstract
Capture essence of goals and objectives
Abstract
Present your project Concisely
State significance Clearly
State Hypotheses, Research Problem, Solution
Methods and Rationale
Write direct, active text: Read aloud.
Snooze? Fix!

34. 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?

35. Good Presentation Address Scored Review Criteria
Significance: Does the study address an important problem? How will scientific knowledge be advanced?
Investigator: Is the investigator appropriately trained?
Innovation: Are there novel concepts or approaches? Are the aims original and innovative?
Approach: Are design and methods well-developed and appropriate? Are problem areas addressed?
Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

36. 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

37. Good Presentation 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

38. 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

39. 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

40. 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
suggest IC and review group assignment*
Outline key expertise needed for appropriate review
do not name specific reviewers
* Consult with Program Officer

41. 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!

42. Good Luck Results from: Good Ideas Good Grantsmanship
Good Presentation
Good Review

44. 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
This slide describes good grantsmanship, but…..

45. 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

46. 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

47. 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”

48. 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

49. Specific Aims The most critical page in the application
It is a one page summary of the application
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
Be general
Avoid long (laundry) list of things you are going to do
2-3 Specific Aims is sufficient (Focus: must fit together)

50. 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.

51. Preliminary Data Show primary data for critical methods
Make figures or tables readable
Progress Report- for renewals
Restate Aims (avoid laundry list)
Publication list MUST be very strong. No productivity- no grant
Convince reviewer that you can do what you propose

52. 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

53. 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

54. 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
Express gratitude to reviewers if you can muster any. Their criticisms are intended to help you. Even if you don’t agree with them, find a way to acknowledge their point and go on to explain yours.

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56. grants1.nih.gov/grants/oer.htm 56

57. NIH OER NIH Guide for Grants and Contracts

58. NIH Guide for Grants and Contracts
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)

59. Research Portfolio Online Reporting Tool (RePORT) http://report. nih
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

60. grants1.nih.gov/grants/grant_tips.htm 60

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