There is no grantsmanship
that will turn a bad idea into a
good one…

but there are many ways to
disguise a good one!

-William Raub, Past Deputy Director, NIH
   Introduction

   The NEW Research Strategy 2010

   Organization, aesthetics, writing
DO NOT write the application for yourself unless you are going to fund it

Write the application to satisfy the research priorities of the funding
   Significance: relevance to human health and disease

   Innovation: originality of approach

    Approach: feasibility of your methods and appropriateness
    of the budget

   Investigator: PI training and experience

    Environment: suitability of facilities and adequacy of
    support from your institution

   EACH receive a score from 1 (exceptional) to 9 (poor)
Core Review Criteria   New Application
Significance           Research strategy
                       a. Significance
Investigators          Biosketch
                        Personal Statement
Innovation             Research strategy
                        b. Innovation
Approach               Research strategy
                        c. Approach
Environment            Resources
   Each criteria addressed and considered in assigning overall
    score, weighting them as appropriate for each application
   The application does not need to be strong in all
    categories to be judged likely to have major scientific
    impact and thus deserve a high priority score

   For example, PI may propose important work that is not
    innovative but is essential to move the field forward
1. Align structure/content of application with review criteria
2. Shorten to facilitate peer review
   Personal Statement: Tell us why your experience
    and qualifications make you particularly well-
    suited for your role in the project

   Publications: Keep to 15
       5 most recent
       5 best
       5 most relevant to application

   Page limit remains at 4

   Briefly state your role in this grant

   Experience—educational background and training addressing why
    you are suited for this research (job interview)

   How do you fit into the team?
        The current application builds logically on my prior work, and I have chosen
         co-investigators (Drs. A and B) who provide additional expertise in X, Y, Z.
   This is place you get scored for Principal
    Investigator, including
       Background
       Grants and publications you produced relevant to
       Your track record
       Overall training and experience

   Each grant has a different personal statement

   See example at end of this presentation
Project Summary/Abstract
   Project Summary – succinct and accurate description of the
    proposed work
   Informative to other persons working in the same/related field
    and for scientifically/technically literate reader
   No longer than 30 lines of text
Project Narrative
   This is the second component of the ―abstract‖ that defines the
   Using no more than 2-3 sentences, describe the relevance of this
    research to public health
   Use plain language understood by the general public
          Current Research Plan                Restructured Research Plan
  1. Introduction to Application           1. Introduction to Application

  2. Specific Aims                         2. Specific Aims
  3. Background and Significance           3. Research Strategy
                                           a. Significance
  4. Preliminary Studies/Progress Report   b. Innovation
  5. Research Design and Methods           c. Approach (incl. Preliminary Studies)

  6-12                                     4-10 (renumbered)
  13. Select Agent Research                11. Select Agent Research (Modified)
  14-17                                    12-15 (renumbered)
   Page limit for new Research Strategy will be 6 or 12 pages (+1 page
    for Specific Aims)

   Follow FOA page limit instructions (some may differ)

        Current Page Limit            New Page Limit
      <25 pages (e.g., R03, R21) 6 pages
       25 pages (e.g., R01)     12 pages
      ≥25 pages                 Follow FOA Instructions

   Content reduced by ~50%
①   State concisely the goals of the proposed research and summarize the
    expected outcome(s), including the impact that the results of the
    proposed research will exert on the research field(s) involved.

②   List succinctly the specific objectives of the research proposed, e.g.

o   test a stated hypothesis
o   create a novel design
o   solve a specific problem
o   challenge an existing paradigm or clinical practice
o   address a critical barrier to progress in the field, or
o   develop new technology
        The Problem

     Gaps in Knowledge

Proposed Hypothesis/Solution

        Specific Aims

Impact: How research fills gap
   FIRST paragraph– Define the problem/critical need and gap(s) in
    knowledge—short background leading up to the stated problem and
    knowledge gap

   Proposed solution to problem and gap by proposing hypothesis(es)

   Specific Aims –Objectives that test the hypotheses addressing the
    critical need
        e.g., to develop, determine, identify…
        Avoid vague aims, e.g., ―to explore‖

   Expected Outcomes leading to impact on the field

   Impact – probability your study will be successful and will exert a
    powerful sustained influence on the field (derived from
    significance and innovation)
        If it won‘t work, it has no impact, even with high significance
        Address the immediate problem AND your long-term goals
   State your hypothesis clearly
       Understandable
       Testable
       Specific

   Are your aims obtainable within the stated

   Focus your research
       Focus aims in areas for which you have strong supporting
       Aims should be related and cohesive
   The Problem Colon cancer is a fatal disease if not
    detected early. Current medical practice in the US is
    screening colonoscopies for all over age 50, but
    colonoscopies are expensive and invasive. Screening for
    occult blood in stool is inexpensive but ineffective, and
    many cancers are missed. A blood test that could
    accurately detect colon cancer very early would save
   Gaps in Knowledge Current approaches for measuring
    proteins in blood are relatively insensitive, and unlikely to
    detect cancers early enough. Human variability and low
    signal means many independent patient samples must be
   The Solution New proteomic technologies developed by
    my group offer both the sensitivity and throughput needed
    to identify and validate blood biomarkers for early
    detection of colon cancer.
   Hypothesis We hypothesize that colon cancers can be
    more effectively detected using sensitive blood
   Action Plan
Specific Aim 1: Identification of plasma proteins associated with early stages of
   colon cancer using novel mass spectrometric approaches that provide absolute
   protein abundance measurements down to pg/ml levels. These measurements
   will be applied to a unique cohort of colon cancer patients available from
   clinical collaborators
Specific Aim 2: Bioinformatic analysis of over-represented proteins for
   enrichment of specific functions using a variety of software tools including
   KEGG, BIND, and MetaCor
Specific Aim 3: Selection and Validation of candidate biomarkers
Candidate biomarkers selected on the basis of functions known to be associated
   with carcinogenesis will be verified by orthogonal approaches. The top ten
   ten verified candidates will be assessed in 1000 prospectively collected
   plasma samples from early stage colon cancer patients, using a novel high
   throughput proteomics approach
   Expected Outcomes and Impact
The end product of this research will be an affordable
  accurate blood test for early detection of colon cancer
  without colonoscopy. Our approach will use many
  previously successful methods (preliminary studies) to
  increase the probably of success in this proposal.
Successful demonstration of this approach in colon cancer
  will enable application to other cancers in need of early
  detection biomarkers. Future directions of this research
  also include the application of a systems biology
  approach to the large datasets generated in the
  discovery phase that will provide new insights about the
  earliest stages of colon cancer.
   Lack of original or innovative ideas
   Unrealistic or unfocused
        Are the aims specific and focused?
        If there are risks, justify why it‘s important to pursue and how knowledge
         would move the field if the aim was not met

   Poorly justified
        Relationship of aims to what‘s known and what‘s unknown should be obvious

   Purely descriptive, not hypothesis-driven
         ―This proposal looks more like a collection of experiments in which the
         applicants are simply listing experiments according to their expertise in
         specific techniques instead of testing an underlying hypothesis‖
        ―Our enthusiasm was dampened by lack of a hypothesis driven by a specific
   Lack of cohesiveness
       Must be thematically related and form a cohesive unit
       Think of a central hypothesis unifying aims
   Excessive interdependence of aims for success
       Aim 2 to study novel monoclonal antibodies in animal
        disease model should not depend on Aim 1 to generate
        those antibodies
   Describing techniques
       Do not provide details of methods in Aims
   Overly ambitious
       2-4 Aims (R01), 1-2 Aims (R03,R21)
       Gives impression proposal is unfocused or you have not
        thought the proposal through
   No significant impact (even if aims achieved) on
    the field
 Most reviewers make up their minds
       after reading this page

Then they read the rest of the proposal
  looking for support of their opinion
        Current Research Plan                Restructured Research Plan
1. Introduction to Application           1. Introduction to Application

2. Specific Aims                         2. Specific Aims
3. Background and Significance           3. Research Strategy
                                         a. Significance
4. Preliminary Studies/Progress Report   b. Innovation
5. Research Design and Methods           c. Approach (incl. Preliminary Studies)

6-12                                     4-10 (renumbered)
13. Select Agent Research                11. Select Agent Research (Modified)
14-17                                    12-15 (renumbered)
①   Explain the importance of the problem or critical barrier
    to progress in the field that the proposed project

②   Explain how the proposed project will improve scientific
    knowledge, technical capability, and/or clinical practice
    in one or more broad fields.

①   Describe how the concepts, methods, technologies,
    treatments, services, or preventative interventions that
    drive this field will be changed if the proposed aims are
   Make a compelling case—why is this research important
    for the field (broadly and more specifically)?
       Review of published/unpublished work (incl. your own)
   Point out how your research will fill knowledge gaps
       Show that you are aware of the opportunities, gaps, roadblocks,
        and research being done

   If possible, tie significance to the mission of the NIH
    institute — what are their research priorities?
       Check institute website for research priorities
       Check institute PAs/RFAs objectives
   Too diffuse and long
       Showcasing comprehensive and exhaustive background
       This should be ~0.5-1 page focused on addressing the
        NIH requirements for significance

   Significance not related to stated problem and
       If you follow your Specific Aims, you will keep the
        reviewer (and yourself) focused
   Equating significance with illness
       Don‘t argue that a particular disease is significant
       Significance is what you will do to treat the disease

   Low impact research
       ‗Incremental changes‘
       ‗Confirmatory research—duplicative‘
①   Explain how the application challenges and seeks to shift
    current research or clinical practice paradigms.

②   Describe any novel theoretical concepts, approaches or
    methodologies, instrumentation or intervention(s) to be
    developed or used, and any advantage over existing
    methodologies, instrumentation or intervention(s).

③   Explain any refinements, improvements, or new applications
    of theoretical concepts, approaches or methodologies,
    instrumentation or interventions.

   Understand what innovation means for an NIH grant
    application and what the reviewers are looking for
   Research does not necessarily have to create a
    new paradigm

   To be innovative it can
       Shift a current paradigm
       Offer new combination of known methods leading to
        new perspective
       Refine existing model, technology
   It‘s less risky to use an innovative approach to solve an
    existing problem than to take on a problem that‘s highly

   It can be harder to gain acceptance if your ideas are
    clearly outside the mainstream, especially if you are less
       If your proposal is highly innovative, you'll need to make a strong
        case for why you are challenging the existing paradigm and have
        data to support your innovative approach

   But because innovation is a review criterion, you want to
    show how you will break new ground
   Not separate sections as before
   Each woven into Approach by Aim
   For NEW applications for each Specific Aim, describe not
    only your research approach but what preliminary
    studies you have to support that aim
   For COMPETING renewals, describe:
       Progress you have made toward each aim and the approach you
        will use

       Significant changes to the aims and new directions
①   Describe the overall strategy, methodology, and analyses
    to be used to accomplish the specific aims of the project.

②   How will data be collected, analyzed, and interpreted as
    well as any resource sharing plans as appropriate?

③   Discuss potential problems, alternative strategies, and
    benchmarks for success anticipated to achieve the aims.

④   If the project is in the early stages of development,
    describe any strategy to establish feasibility, and address
    the management of any high-risk aspects of the proposed
   Preliminary Studies/Progress Report

   Study design/study strategy

   Experimental approach
        Experiments to address each SA
        Emphasize
            Unique methods but abbreviate standard methods, especially if
             used in ―Preliminary Studies‖
            Methods not previously used — collaborators
        Use tables and figures to illustrate complex experiments with multiple
         arms or repetitions under different conditions

   Interpretation of results
        Even if your experiment is well designed, its interpretation is vital to
         the reviewer
        Link the interpretation to your proposed SA and hypothesis
   Potential Pitfalls and Alternative Approach
       Roadblocks to your experimental approach and how you would adjust
        the approach to move forward
       Failure to see weak points gives reviewers impression your approach is
        careless and less likely to succeed

   For early-stage PI, strategy to establish feasibility with
       A new investigator is given leeway with some aspects of the grant,
        such as preliminary data, but NOT with approach, anticipated results,
        and lack of plans for possible problems
   Future Directions
       Discuss what‘s likely not feasible for this grant period, and what
        future studies will focus on

   Milestones and Timeline
       By each aim, provide quantitative benchmarks for assessing your
        progress over the grant years
   Excessive detail on approaches or inconsistency in
       Level of detail proportional to the novelty of the
       Standard techniques should not have detail — reference
        or show in preliminary studies

   Feasibility of each aim not shown
       Listing your experiments without tying them to the SAs
        will kill your grant
   Lack of ―pitfalls and alternative approaches‖
       Being able to propose alternative approaches to your aims if
        your plan fails, or provide new directions if your hypotheses
        need revision, score big with reviewers

   Overly ambitious in scope
       This is a blueprint for your work, not a wish list for experiments
        that you think impressive
       If the studies are not achievable in the timeframe of the grant,
        this may become future work
   Lack of a section ―Interpretation of Results‖
       Meaning of the results is not always clear to reviewers
       Demonstrates your capacity to
            predict the results
            consider alternative results
            refine your hypothesis
            adjust the plan
            assess the impact of the data

   Lack of clear logistical organization and plan
    for the grant period
       Provide a timeline for completing the aims
   Your experimental approach is not hypothesis-driven
       ―Fishing expedition‖ without clear goals
       Focus and prioritize experiments around your aims/hypothesis

   Excessive dependence of experimental plans
       Aims that depend on one other for success are susceptible to
       Interdependence of thematically related aims is necessary, but the
        experiments and aims should be diverse enough to assure some level
        of success
   Quantitative benchmarks for comprehensively assessing the annual
    progress of the projects-- not be simply a restatement of the specific
   Timeline and a ―pathway‖ for the development of the proposed
   Examples:
-Detect one cancer cell in 106 normal blood cells.
-Increase the therapeutic index of an agent >3-fold by nanoparticle-based
    therapeutic solution relative to the non-nanoparticle bound agent.
-Achieve >95% selectivity in targeting mixed cell populations in vitro.
Summarize how these studies and
this design will answer each of
your aims

Include milestones and timeline
   Outline the application
   Focus on strategy rather than experimental details
   Use graphics to convey complex info in a small space
   Do not decrease fonts, margins, white space
   More time to write shorter—thoughtful revising necessary
   Reduce redundancies—outline
   Use active voice and write short, direct sentences
   Read long sections aloud
   Give to an editor
You cannot edit a 25/12-page document to 12/6
  Why is my research important
  (significant) to health/disease?
Can I do it…and qualified to do it?
Will it have significant impact on
              the field?
             ―…psychological mechanisms came into
             play…once I lost patience with an applicant for
             writing a disorganized section, I was much more
             likely to notice other faults in the proposal.
             Also, when a proposal was sloppy, it was difficult
             not to extrapolate that the applicant‘s labwork
             was sloppy as well.‖

―At the other extreme, the easier the applicant made it for
me to get the information necessary to assess the
application, the more likely I was—if the science was
sound—to have a positive feeling about the proposal.‖
―In >20 years of reviewing, during which time I have
seen >1000 R01s, the most common shortcoming I
have seen has been poor writing…‖

Bernard L. Trumpower, PhD Dartmouth Biochemist
   Consider the grant as a unit to establish a logical
    progression from Specific Aims through Approach

   Eliminates disorganized, illogical thought and poor

   Eliminates redundancies and omissions

   Provides fixed points of reference that reduces complex
    revisions and eliminates redundancies

   Forces brevity, clarity, and a cohesive application
   Organization is key! Start with an outline

   Number headings— help reviewers navigate with ease
       5.0, 5.1, 5.1.1, 5.2

   Summary statements at end of each section

   Tables of timelines, figures of program organization

   Assure you have included all requirements in each section
    of the grant. Double check the PHS398 (and PA or RFP)
   Don‘t jump into writing — Write your Aims page and give it to an
    experienced PI for evaluation.

   Propose something significant — Are you dealing with key controversies
    and problems in the field or rehashing a previous project or idea?

   Good ideas don‘t always sell themselves — Tell me why it‘s important
    up front in the significance section…tell me what‘s known and what
    isn‘t known and how you‘ll move the field forward or answer important

   Don‘t cram your application like a suitcase — Pay attention to fonts,
    margins, and spacing.
   Aim each aim — Spend time on the Expected Outcomes, Data
    Interpretation, Pitfalls, and Contingencies section for
    accomplishing each aim.

   Pull it together — At the end of your approach section, write a
    succinct, one-paragraph summary of what you intend to do, how
    you intend to do it, and what it is going to tell you — write it like a
    manuscript abstract.

   Have a good editor/writer proofread your application — Many
    unnecessary errors may kill your application.
   IMPACT        S     DESCRIPTOR                     STRENGHTS/WEAKNESSES
High             1    Exceptional
                 2    Outstanding                                          Strengths
                 3    Excellent
Moderate         4    Very Good
                 5    Good
                 6    Satisfactory
Low              7    Fair
                 8    Marginal
                 9    Poor
Non-numeric scores:
NR=Not recommended for further consideration DF=Deferred   AB=Abstention   CF=Conflict
NP=Not present ND=Not discussed
   Discussed applications receive impact/priority scores from all
    eligible reviewers in whole numbers only (no decimal ratings).

   Assigned reviewers also provide ratings for each review criterion
    [e.g. Significance, Investigator, Innovation, Approach, Environment]
    using the same 9-point scale.

   These criterion ratings are provided in the summary statement for
    applications, both discussed and not discussed. Criterion ratings
    should be considered in determining the overall impact/priority
    score, but reviewers should determine the relative importance of
    each criterion for the science or work being proposed.
   Which PA, RFP, Institute?
   Read the PHS398 and PA/RFA instructions!
   Formulate a solid hypothesis and write your
    Specific Aims (SAs) first
   Run your SA page past several colleagues
   Center research plan around SAs
   Follow a timeline
   Program Announcement (PA)
       Broad funding announcements for areas of priority and emphasis
        using particular funding mechanisms
       Ongoing, open for 3 years
       Multiple receipt dates
       PA-10-025 Development, Application, and Evaluation of
        Prediction Models for Cancer Risk and Prognosis (R01)
   Request for Application (RFA)
       More narrow than PA, by institute
       One-time solicitations for grant applications addressing a
        defined research topic
       Single receipt date
       Competition depends on # applications and $$ set aside
       CA09-026 The Biology of Estrogen Receptor-Negative Breast
        Cancer in Various Racial and Ethnic Groups (U01)
   Does your research involve human subjects or are you
    just analyzing human data?
   Protection of Human Subjects
       Identify the risks
       Describe protection against those risks
       Consent (IRB)
   Justify inclusion of Women, Minorities, Children
   Inclusion Enrollment Table (ethnic & racial categories)
   Research on transplantation of human fetal tissue
   Human embryonic stem cells
   Data and safety monitoring plan (for clinical trials)
   Some exemptions
   Describe use of animals outlined in Section D: species,
    strains, ages, sex, numbers

   Justify use of animals, choice of species, and numbers

   Describe veterinary care

   Procedures to minimize discomfort, pain, injury

   Describe methods for euthanasia consistent with Panel
    on Euthanasia of the American Veterinary Medical
    Association (AVMA)
   Must match your research plan

   Must use NIH budget forms and justify all expenses (OSP can
       Personnel
       Consultants
       Supplies
       Travel
       Human subject payments

   For multi-institutional applications, must be separate
    budgets for each subcontractor

   Justification: no length requirement, but be succinct and
   Describe in detail the core facilities (not personnel)
    used in the study
       Physical resources—departmental offices, labs, etc.
       Equipment—describe those used, those needed
       Other university resources—MRI facilities, testing labs, etc.
       Provide space description (sq. ft., # offices, labs, etc).
       Be specific

       Be sure this section is consistent with budget/justification
   About 3-4 pages

   Use specified forms
   Color illustrations from the grant must be included in all

   Manuscripts (10 max) from your lab supporting the

   Protocols and Procedures used in your research

   Large tables & Figures supporting the application

   Don‘t include critical information — appendices are not required to
    be read by reviewers

   Don‘t include consultant letters (they are in ―Section 16‖)
   Always discuss potential problem areas and alternative

   Never assume that reviewers will know what you mean.

   Be explicit about what you want the reviewers to know and
    what they need to know.

   READ the application instructions carefully.

   Stay within page limits.
   Secure collaborators for areas you lack experience and

   There are no competitors in science, only potential

   ―Independent Researcher‖ does not mean that you work in

   ―Independent Researcher‖ does mean that you set the direction of
    the research.

   Don‘t give the impression of being intellectually ―Isolated‖.
   If your application is a renewal or supplement request,
    know that study section members will not have the
    benefit of your previous application but rather only the
    previous summary statement.

   Be sure to explain your progress carefully in the current

   Publish, Publish, Publish - be productive.

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