successful grant writing for nih cheryl anne boyce, ph.d. chief, behavioral and brain development...
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Successful Grant Writing for NIHSuccessful Grant Writing for NIH
Cheryl Anne Cheryl Anne BoyceBoyce, Ph.D., Ph.D.
Chief, Behavioral and Brain Development BranchChief, Behavioral and Brain Development Branch
Associate Director, Child and Adolescent ResearchAssociate Director, Child and Adolescent Research
Division of Clinical Neuroscience and Behavioral ResearchDivision of Clinical Neuroscience and Behavioral Research
National Institute on Drug AbuseNational Institute on Drug Abuse
Houston Baker, Ph.D.Houston Baker, Ph.D.
Program Director Program Director
Imaging Technology Development BranchImaging Technology Development Branch
Cancer Imaging ProgramCancer Imaging Program
National Cancer InstituteNational Cancer Institute
““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
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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?
• Impact Score—Scientific merit Impact Score—Scientific merit
• Program considerationsProgram considerations
• Availability of fundsAvailability of funds
NIH Award MechanismsNIH Award Mechanisms
GrantsNumerous grant mechanismsR01s, 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 networksSubstantial NIH staff involvementSolicited—Request for Applications (RFA)
Contracts N01sSolicited—Request for Proposals (RFP)
Three Ways to Work with an ICThree 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.
Grant Submission DatesGrant Submission Dateshttp://grants.nih.gov/grants/funding/submissionschedule.htm#elec
Electronic SubmissionElectronic Submission
Most NIH grant applications require electronic submission via http://Grants.Gov
eRA Commons: secure web-based information exchange between NIH and applicant organization (PI and Business Official) http://commons.era.nih.gov
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
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
“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 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
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
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 Investigators Innovation Approach 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
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 Scored Review CriteriaScored 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 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!
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 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?
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
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
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)
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 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
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
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)
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