Elizabeth S. Burnside, MD, MPH

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Preparing a R01 Research Application

• Elizabeth S. Burnside, MD, MPH

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Objectives

• Motivation-Preparation
• Regulations
• Directions/Changes
• Relationship to Review Criteria
• Specific Guidance on Scientific Sections
• Why grant fail
• Why you can succeed!

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Why the R01?

• Why and R01
• Long-term funding
• Most awards for 3-5 years
• Fund research infrastructure
• Often renewable
• Highly valued
• Peer-reviewed
• Recognized stamp of approval
• Useful or required for promotion

4
Ready, Set, Plan!

• Get education you need
• Understand appropriate funding sources
• Individual/program maturity
• Have Department/Institutional support
• Find a mentor
• Develop institutional collaborators
• Do a Review

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Important Groundwork
TALK TO Program Directors or Project Officers

• Think up a good idea
• Review the literature
• Give a lecture on the topic
• Pay attention to feedback
• Reality test with a mentor
• Refine the ideas together

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Most Important
Most Important Least Exciting
Read the Directions
Follow the Directions
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Timeline for Changes

• Read about the application changes now
• Begin working on Research Strategy, but wait to
  download the forms when they become available
  starting December 1

• Use new forms for applications due on or after
  January 25, 2010

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What are the Directions?
Deadlines Feb June Oct

• SF 424 (RR)
• Announcement
• PA (PAS or PAR)
• RFA
• RFP
• FOA

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Alignment of the Application with Peer Review
Criteria

• Application forms will be revised in three
  sections
• Research plan
• Resources
• Biographical sketch

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New Research Plan Components
Current Research Plan (Section 5.5) Restructured Research Plan (Section 5.5)
1.Introduction to Application 1. Introduction to Application
2. Specific Aims 2. Specific Aims
3. Background and Significance 3. Research Strategy a. Significanceb. Innovationc. Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision Applications
4. Preliminary Studies/Progress Report 3. Research Strategy a. Significanceb. Innovationc. Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision Applications
5. Research Design and Methods 3. Research Strategy a. Significanceb. Innovationc. Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision Applications
6. to 12. 4. to 10. (renumbered)
13. Select Agent Research 11. Select Agent Research (modified)
14. to 17. 12. to 15. (renumbered)
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Other Components

1. Inclusion and Enrollment Report
2. Progress Report Publication List
3. Protection of Human Subjects
4. Inclusion of Women and Minorities
5. Targeted/Planned Enrollment
6. Inclusion of Children
7. Vertebrate Animals
8. Select Agent Research
9. Multiple PI Leadership Plan
10. Consortium Arrangements
11. Letters of Support
12. Resource Sharing Plans

1. Inclusion and Enrollment Report
2. Progress Report Publication List
3. Protection of Human Subjects
4. Inclusion of Women and Minorities
5. Targeted/Planned Enrollment
6. Inclusion of Children
7. Vertebrate Animals
8. Select Agent Research (modified)
9. Multiple PI Leadership Plan
10. Consortium Arrangements
11. Letters of Support
12. Resource Sharing Plan

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Page Limits
Current Page Limit (Section 2-5 of the Research Plan) New Page Limit (Research Strategy)
lt25 6
25 12
gt25 Follow Announcment Instructions
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Main Proposal Components

• Specific Aims
• Significance
• Innovation
• Approach

• Significance
• Investigator(s)
• Innovation
• Approach
• Environment

Review Criteria
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NIH Review Criteria

• Significance
• Does research
• Address an important problem?
• Advance knowledge in the field?
• Effect existing concepts that drive the field?

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NIH Review Criteria (cond)

• Innovation
• Are the aims original and innovative?
• Are concepts, approaches or methods novel?
• Does the project challenge existing paradigms or
  develop new methodologies or technologies?

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NIH Review Criteria (cond)

• Approach
• Are the conceptual framework, design, methods and
  analyses adequately developed, well integrated
  and appropriate to the aims?
• Does the applicant acknowledge potential problem
  areas and consider alternative approaches?

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Main Proposal Components

• Specific Aims
• Significance
• Innovation
• Approach

• Significance
• Investigator(s)
• Innovation
• Approach
• Environment

Review Criteria
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Grant Components (other stuff)

• Abstract
• Budgets and Budget Justification
• Biosketches
• Resources
• Letters of Support (14)

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Revisions to Biographical Sketch

• Personal Statement added
• Experience and qualifications particularly
  well-suited for your role in the project
• Publications revised
• no more than 15 publications
• Emphasize recency, importance to the field,
  and/or relevance to the application

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Revisions to Resources

• Instructions added to Resources
• How the scientific environment will contribute to
  the probability of success
• Institutional investment in the new investigator
  (ESI)
• Instructions added to Research Plan
• Select Agents Research describe the
  biocontainment resources (11)

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Specifics

• SF424 (RR) Application and Electronic Submission
  Information is available at
• http//grants.nih.gov/grants/funding/424/index.htm

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Specific Aims

• Executive summary
• Remainder of proposal must flow from it
• MAJOR influence on reviewers
• may be the only page non-assigned reviewers read
• Write it first, last and every day in between
• Generally includes
• body/text
• numbered aims sub-aims

Hypothesis
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Specific Aims

• Broad, clearly defined aims (generally 3)
• Precise sub-aims
• Clear statement of work using strong terms such
  as define, determine, demonstrate
• Must accomplish goal and lead to endpoint
• Dont need to mention methods
• Methods accomplish aims, aims are not methods
• Specific hypotheses
• correspond to the aims

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Significance

• Why spend the money?
• current state of knowledge, unresolved issues
• Relationship to other work in the field
• demonstrate potential impact on healthcare
• know the study section reference their work
• FOCUS IS VERY IMPORTANT
• NOT too large in scope

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Innovation

• What is novel?
• Many opportunities for innovation
• scientific question is new
• aims challenge existing paradigms
• project develops new methodologies or
  technologies
• concepts, approaches or methods are novel

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Approach

• Overview
• summarize work to be done and importance
• often similar structure to body/text of Aims page
• overall approach should be logical
• think of this as the big picture
• Research team/environment
• describe roles of key personnel
• convince reviewers that you have the best
  possible team
• highlight institutional strengths that make it
  likely the proposed research will be successful

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Preliminary Studies

• Demonstrate your expertise as a researcher
• Show experience with specific techniques to be
  used
• Demonstrate clinical expertise access to
  patients
• Highlight expertise of collaborators as
  complementary
• Results must support aims of study
• ideally, suggest need for research you are
  proposing
• Indicates that specific aims are reasonable
• note NIH uses 5 acceptable failure rate

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Approach (cond)

• Timeline/timetable
• generally includes text graphics
• justify funding period or expect to be cut
• detail verifies understanding of the project
  methods
• Detailed methods
• parallel aims/hypotheses VERBATIM (check!)
• include
• recruitment strategies,
• sample size calculations
• statistical approaches
• absolutely no hand waving

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Approach (cond)

• Anticipated results limitations
• important section that is frequently omitted
• anticipate potential problems propose solutions
• provides reviewer insight into how you might
  handle the problems that will almost invariably
  arise

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Why Grants Fail

• Poor science
• the quality of the research is the most
  important sending in an application with poor
  science is the SUREST WAY TO FAIL
• Poor organization
• if the proposal is hard to follow, the reviewer
  will get frustrated and/or angry and simply give
  up

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Why Grants Fail (cond)

• Poor integration
• Different parts of the proposal must clearly
  relate to each other convince the reviewer
• worth doing (Significance)
• can be done (Preliminary studies)
• has been carefully thought through (Approach)
• No Contradiction or superficiality
• internally consistent
• detailed enough

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Why Grants Fail (cond)

• Inadequate qualifications
• PI (you) must be capable of doing the work
• Collaborators support personnel need to be
  sufficiently qualified adequately funded
• Environment needs to have the infrastructure to
  support scientific aims

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Grant Writing Pointers

• Do a Review
• Walk in their shoes
• Proposal should be interesting and easy to read
• Use formatting for clarity
• text, figures, legends must be legible to
• margin font guidelines
• subheadings boldings

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Advice

• Talk early and often to project officers
• Email first
• Contact by phone
• Persistence The way it used to be

Rejection
FUNDING
Ugh !
Yay !
Submission
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Advice

• Talk early and often to project officers
• Email first
• Contact by phone
• Now only 2 application rounds!

FUNDING
Rejection
Ugh !
Yay !
Submission
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Conclusions

• Generate an OUTSTANDING PROPOSAL
• Capture the reviewers interest
• Focus less is often more

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Questions?