THE NIH GRANT WRITING AND PEER REVIEW TOOLBOX

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THE NIH GRANT WRITING AND PEER REVIEW TOOLBOX

• Adolphus Toliver, Ph.D.
• Division of Minority Opportunities in Research,
• National Institute of General Medical Sciences

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Contents of the Toolbox

• The toolbox contains tips and tools about
• Research Grants
• Peer Review
• People
• Resources
• Databases

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National Institutes of Health

• The pursuit of science to uncover new
  knowledge that will lead to better health for
  everyone.
• NIH works toward this mission by
• Conducting research in our own labs (1K PIs)
• Supporting research at various institutions (212K
  PIs)
• Fostering communication of medical health info
• Training research investigators

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Review Process for a Research Grant Application
Center for Scientific Review
Initiates Research Idea
Assign to IRG/ Study Section
Submits Application to NIH
Study Section
Review for Scientific Merit
Institute
Evaluate for Relevance
Advisory Councils and Boards
Allocates Funds
Recommends Action
Institute Director
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LIFE CYCLE OF A RESEARCH GRANT

• Develop a critical idea for a research proposal
• Respond to
• Program Announcement (PA)
• Request for Applications (RFA)
• Investigator Initiated Grant

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LIFE CYCLE OF A RESEARCH GRANT

• Submit the grant application to the
• funding agency
• Submission dates October 1, February 1, June 1
• Reviewed in Feb/March, June/July, Oct/Nov
• Goes to Institute advisory Council May/June,
  Sept/Oct, Jan/Feb
• Earliest award July, December, April

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PREPARING AN APPLICATION

• read the instructions
• Read the Instructions
• READ THE INSTRUCTIONS
• Read the CORRECT instructions, i.e., those
  pertaining to the grant for which you are
  applying
• Read all of the instructions and follow the most
  current instructions

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THE WRITTEN PRESENTATION

• Information is interpreted more easily if it is
  placed where most readers expect to find it.
• For clarity, use simple declarative sentences.
• Avoid complicated words, unusual abbreviations,
  and poor syntax
• The application should be easy to read and
  comprehensible

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TYPICAL PROPOSAL SEQUENCE FOR READING

• Title page and abstract
• Introduction and the problem (need)
• Specific aims or measurable objectives
• Significance (literature review and background)
• Progress report
• Research plans (research design and methodology
• Budget and Biographic sketch

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CONCEPTUAL STRUCTURE OF A GRANT APPLICATION

• IDEA
• SUPPORTING IDEAS
• DETAILS OF THE PLAN
• APPENDICDES

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TYPICAL SEQUENCE FOR PROPOSAL DEVELOPMENT

• The problem or need
• Significance
• Specific aims
• Research plan
• Budget
• Biographical sketch
• Abstract

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REQUIREMENTS FOR A COMPETITIVE RESEARCH
APPLICATION

• Brief introduction including the long range goal
  of the project
• Background to establish a solid foundation on
  which to build your proposal
• The goal of this particular application
• The central hypothesis to be examined
• Rationale for the project
• Specific Aims
• Anticipated results

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BRIEF INTRODUCTION

• Underscores the importance of the proposed
  studies
• Should convey the important findings in the field
  of study
• Should highlight the problem that proposed
  studies will address

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LONG-RANGE GOAL

• It is the goal of the overall program of which
  the current application is a part.
• It is NOT the goal of the current application.

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CENTRAL HYPOTHESIS

• If possible,the proposed research should be
  hypothesis driven!
• The hypothesis must be testable and should select
  an experimental outcome from among various
  possiblities.
• The hypothesis should NOTpresent a predetermined
  conclusion.

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RATIONALE

• This is the underlying reason for the studies
  proposed
• The rationale must be relevant to the problem
  that has been presented in the introduction.

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SPECIFIC AIMS

• They should be brief, focused, and limited in
  scope.
• Each aim should logically flow into the next aim.
• Each aim should be briefly expanded upon.
• Be realistic do not overestimate your abilities
  or capabilities for completing the work proposed
  in your application in the time requested.

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BACKGROUND

• The purpose of the Background
• To establish a solid foundation on which to build
  your proposal.
• Is NOT to impress reviewers with your
  comprehensive knowledge of the field.

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PREPARATION OF THE APPLICATION
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PROBLEM OR NEEDS STATEMENT

• What Exists Now
• What Is
• Present level of knowledge

• What Should Be
• What Ought to Be
• Desired State of Knowledge

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PROBLEM OR NEEDS STATEMENT

• The problem or needs statement is the
• disparity between what is and what
• should be, that created the GAP which
• your proposed project will attempt to
• close of make smaller.

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PRELIMINARY STUDIES

• Describe published studies in limited detail and
  include the most important figures and/or tables.
• Describe unpublished studies in more complete
  detail, including newer data.
• Do not duplicate the preliminary studies with the
  proposed studies.

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PRELIMINARY STUDIES

• Include the results of your recent work that have
  direct relevance to the studies proposed in your
  grant application.
• Exclude any studies in which the relationship to
  your proposed study is not relevant.

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EDITORIAL CONSIDERATIONS FOR PRELIMINARY STUDIES

• All figures/graphs and tables should be clearly
  legible.
• Provide original photographs of gels xerox
  copies are not easily interpreted.
• Methodology should be placed in the figure/table
  legends, not in the text.

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TECHNICAL CONSIDERATIONS FOR PRELIMINARY STUDIES

• Graphs should be uncomplicated the simpler, the
  better.
• Each table or figure should be designed to convey
  a single point or idea.
• Extraneous or irrelevant data should be avoided.

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THE RESEARCH DESIGN

• This is the heart and soul of the
• application. In this section, state precisely
• What you propose to do
• How you plan to do it
• What the results will mean in terms of the
  overall project
• What pitfalls you might consider
• Alternative approaches to cope with the
  anticipated problems or pitfalls

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RESEARCH DESIGN continued

• Restate each Specific Aim and for
• each, provide
• Introduction
• A methods of approach
• Anticipated findings or results
• Potential pitfalls/alternative approaches

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RESEARCH DESIGN continued

• INTRODUCTION
• Each section of the research design should
• restate the hypothesis to be tested, the
• rationale for the study, overall approaches
• to be taken, and the anticipated results.

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RESEARCH DESIGN, continued

• METHODS OF APPROACH
• Separate sections on the specific aims should be
  used to develop each of the planned studies.
• This section is not intended to be a materials
  and methods manual therefore avoid emphasis on
  routine methods.
• Use detailed methods only for unfamiliar
  technology

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RESEARCH DESIGN, continued

• ANTICIPATED RESULTS
• Summarize your results.
• Emphasize only the most important results.
• Do not over-inflate or under-inflate the results.
• If limitations exist, they should not be ignored,
  but should be discussed in a positive manner.

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RESEARCH DESIGN, continued

• POTENTIAL PROBLEMS
• Anticipate potential problems, and discuss them,
  but do not overemphasize them.
• Offer alternative strategies.
• Reconcile the results of differing approaches.

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SOME COMMON REASONS FOR FAILURE

• Lack of an innovative or good original idea
• Unimportant or unresponsive problem
• Inadequately developed methodology
• Unacceptable rationale
• Lack of expertise, experience or resources
• Superficial or unfocused approach
• Unrealistic amount of work proposed
• Uncertain outcomes and/or lack of future
  directions.

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BIOGRAPHICAL SKETCH

• Document your credentials accurately
• Provide aspects of your training and expertise
  that are relevant to the application.
• Do not misrepresent your publication record
• Do not include unimportant or non-relevant entries

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THE BUDGET

• The budget should never drive the proposal.
• Justify all personnel with respect to effort and
  expertise.
• The equipment request must be congruent with the
  resource statement and stem from the proposed
  methodology
• Dont ask for a Mercedes when a Saturn will do.
• Strongly justify all equipment requested
• Supply request should match your research design,
  and be strongly justified.

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THE ABSTRACT

• It should be written after the project has been
  completed because the writer will have a clear
  idea of exactly what information is to be
  distilled and summarized.
• It should be succinct and motivating because is
  the most often read section of a grant
  application.
• It is a summary of the proposal it does not list
  objectives, it summarizes them.

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TIPS FOR WRITING PROPOSALS

• Write with reader in mind because readers do not
  simply read, they interpret.
• Most readers may make his/her most interpretative
  decisions about the substance or prose based on
  the clues they receive from the structure of the
  presentation.
• Remember that information is interpreted more
  easily and uniformly if it is placed where most
  readers expect to find it.

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REVIEW PROCESS FOR RESEARCH GRANT APPLICATIONS

• Application is submitted to CSR
• Assigned to an Initial Review Group (IRG)
• IRG reviews application for scientific merit
• Advisory Council for Institutes/Centers (IC)
  recommends action
• ICs take final action and allocates funds

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CENTER FOR SCIENTIFIC REVIEW (CSR)

• Serves as central receipt point for NIH grant
  applications
• Assigns applications to CSR IRGs or IC IRGs for
  review
• Assigns applications to NIH ICs as potential
  funding components
• Conducts initial scientific review o grant
  applications submitted to NIH

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PEER REVIEW in CSR

• CSR IRGs are managed by a Scientific Review
  Administrator (SRA) who is a Ph.D. professional
  with a scientific background close to the
  expertise of the IRG.
• Each CSR standing IRG has 12-24 members who are
  primarily from academia
• As many as 60-100 applications are reviewed at
  each IRG meeting

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RESPONSIBILITIES OF THE SRA

• Performs administrative and technical review of
  applications
• Selects the reviewers for an application
• Manages the IRG
• Prepares the Summary Statement
• Provides requested information about IRG
  recommendations to the ICs National Advisory
  Councils/Boards

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CRITERIA for SELECTION OF REVIEWERS

• Demonstrated scientific expertise
• Doctoral degree or equivalent
• Mature judgment
• Work effectively in a group context
• Breadth of perspective
• Impartiality
• Interested in serving
• Adequate representation of women and individuals
  from groups underrepresented in the biomedical
  research arena of the nation.

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REVIEW CRITERIA

• Significance
• Approach
• Innovation
• Investigator
• Environment

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SCORING OF APPLICATIONS

• 1 Exceptional
• 2 Outstanding
• 3 Excellent
• 4 Very Good
• 5 Good
• 6 Satisfactory
• 7 Fair
• 8 Marginal
• 9 Poor

NFRC Not recommended for further
consideration UN Unscored
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Scoring Descriptions
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RESEARCH GRANT APPLICATIONS

• People To Know and Why You Need To Know Them
• Institute and Center Directors
• Institute Division Directors
• Institute Branch Chiefs and Program Directors
  (Administrators)
• Scientific Review Administrators

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RESEARCH GRANT APPLICATIONS

• Responsibilities of Branch Chiefs
• and Program Directors
• Primary contact and information link
• Post-review discussions
• Pre-award discussions

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BRANCH CHIEFS AND PROGRAM DIRECTORS

• Primary Contact and Information Link
• Program Announcements (PAs)
• Requests for Applications (RFAs)
• Requests for Proposals (RFPs)
• Upcoming initiatives
• Opportunities for new initiatives
• Information about NIH Program Policies

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BRANCH CHIEFS AND PROGRAM DIRECTORS

• Post-review Discussions
• Responding to summary statements
• No action needed
• Informational letters
• Appeal letters
• Resubmission
• Deferrals

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COMPUTERIZED DATABASES

• A tool for knowing what NIH has funded
• http//www-commons.cit.nih.gov/crisp
• A tool for knowing what NIH is funding
• and the latest requests for applications
• (RFA) or Program Announcements (PA)
• http//www.nih.gov/grants/guide/index.html

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COMPUTERIZED DATABASES

• Selected Sites of Interest
• CSR (http//csr.nih.gov)
• Referral and Review
• (http//www.csr.nih.gov/refrev.htm)
• Overview of Peer Review
• (http//www.csr.nih.gov/review/peerev.htm)
• CSR Study Sections
• (http//www.csr.nih.gov/committes/rosterindes.asp
  )

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Dual Review System for Grant Applications

• First Level of Review
• Scientific Review Group (SRG)
• - Provides Initial Scientific Merit
  Review of Applications
• - Rates Apps and Makes Recommendations
• for Appropriate level of support duration
  of award

• Second Level of Review
• Council
• - Assesses quality of SRG review of apps
• - Makes recommendations to staff for funding
• - Evaluates program priorities and relevance
• - Advices on policy

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Council Actions

• Concurrence with study section action
• Modification of study section action
• Deferral for re-review