Crafting An Outstanding NIH Grant Application An insider

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Crafting An Outstanding NIH Grant ApplicationAn
insiders perspective

• Martin Padarathsingh, Ph.D.
• Referral Officer Scientific Review
  Administrator
• Center for Scientific Review/NIH
• Research Proposal Consultant, H. Lee Moffitt
  Cancer Center Research Institute

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Outline

• NIH Peer Review Process
• Grantsmanship Guidelines
• Study Section Actions
• Application - Revision

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REVIEW PROCESS FOR A RESEARCH GRANT
Review Process for a Research Grant
National Institutes of Health

• Principal
• Investigator

School or Other Research Center
Center for Scientific Review

Assign to
IC and IRG
Scientific Review Group
Initiates Research Idea
Submits application
Review for
Scientific Merit
Institute
Evaluate for
Relevance
Advisory Council or Board
Recommend
Action
Allocates Funds
Institute Director
Conducts Research
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Receipt DeadlinesR01 Applications
Receipt Deadlines R01/Fellowship Applications

• NEW
• February 5
• June 5
• October 5

• REVISED
• (Competing)
• March 5
• July 5
• November 5

• FELLOWSHIP
• April 8
• August 8
• December 8

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Applications Submitted to NIH
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Duties of Referral Officers
Applications
Funding Institutes
SRA/Study Section CSR, Institutes

1. Assignment to Funding Institutes
2. Assignments to Study Sections

Reviewers Study Section Meeting
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Assignment of Applications

• The applications are first examined by Asst.
  Chiefs in the Division of Referral and Review
  they are forwarded to the appropriate Referral
  Officer based on the area of proposed research.
  Referral Officers ensure that the applications
  are assigned to the appropriate Initial Review
  Groups (IRGs).
• There are about 23 IRGs, specializing in
  Oncology, Cell Biology, Immunology, Neurology
  etc. Each IRG has multiple study sections

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Applications Related to Cancer

• There are 17 study sections within the ONC IRG.
  They cover a wide spectrum of cancer research
  ranging from basic biology, drug discovery,
  translational sciences and clinical trials.
• Each application is assigned to a specific study
  section based on the type of studies proposed.
  This assignment is determined by the Referral
  Officers and the SRAs of the ONC IRG.
• Some applications will be assigned to a Special
  Emphasis Panel based on certain criteria.

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Presubmission Preparation

• Interact with NIH staff Colleagues
• Scientific Review Administrator
• - Identify study session
• Program Director
• - Specific research areas
• - RFAs, PAs, special initiatives
• Seek the advice of colleagues at your home
  institution

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Other Types of Awards

• MERIT Awards
• Provides extended funding period for outstanding
  competing renewal RO1 applications
• Shannon Awards
• Provides funding for grants from new
  investigators who are marginally outside the
  payline applications
• Minority Supplements

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When Preparing Your Application

• Read Instructions PHS 398/SF424
• Attention to Administrative Details
• Font Size Font Size
• Animal and Human Studies
• Letters from Collaborators
• Appendices Manuscripts
• Mentor (Fellowship)

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When Preparing Your Application Cont.

• Never assume that the reviewers will know what
  you mean - CLARITY
• Refer to the literature thoroughly
• State rationale of proposed investigation
• Present an organized, lucid write-up
• Include well-designed tables and figures
• Obtain pre-view from colleagues - in essence an
  internal pre-review before submission to the NIH

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Review Criteria

• Significance
• Approach
• Innovation
• Investigator
• Environment
• Budget is not considered in the scientific
  evaluation

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Significance

• Important area of research
• Target sites breast, lung, prostate, skin
• Carcinogenesis mechanisms
• Development of new reagents, methodology,
  treatment
• Convince the reviewers that the proposed work is
  important

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Approach

• Hypothesis and Mechanism
• Preliminary Data - should be strong and
  convincing
• Specific Aims
• Experimental Design - questions
• Results, impact, future directions
• Potential Pitfalls and Alternatives

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Potential Pitfalls and Alternatives

• A substantial weakness is a serious lack of
  potential problems and alternative possible
  results, and consequent alternative approaches
  which will be utilized. This imparts the
  impression that the success of the proposal is
  absolutely dependent on achieving the expected
  results.

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Innovation

• Novel concepts and approaches
• Project challenges existing paradigms and/or
  introduces new paradigms
• Original and innovative aims
• Innovative use of existing technologies
• Development of new reagents, models,
  methodologies and technologies

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Investigator

• Appropriate training and expertise
• Productivity track record
• Collaborators and consultants
• Network

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New Investigator

• A person who has never been a pi on a NIH RO1
  grant
• Check new investigator box (2) on PHS 398 face
  page
• Productivity
• Independence, resources
• Letters of support from collaborators and
  chairperson
• Period of award
• Paylines special treatment (?)

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Environment

• Intellectual and physical environment
• Unique features facilities, resident experts
• Does the scientific environment contribute to the
  probability of success?

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Streamlining Pre-study Section Action

• Divide applications into upper and lower halves
• Unscore applications in lower half
• Decision to unscore MUST BE UNANIMOUS
• Unscored applications are not discussed.
  Applicants receive unedited critiques from the
  reviewers in their Summary Statements

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Scientific Review Group or Study Section Actions

• Scored, Scientific Merit Rating priority scores
• Unscored unanimous decision
• Deferred

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Priority Scores

• Outstanding 1.0 1.5
• Excellent 1.5 2.0
• Very Good 2.0 2.5
• Good 2.5 3.5
• Acceptable 3.5 5.0
• Unscored applications fall in the range of 3.0
  -5.0 they are not without scientific merit!

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Outstanding Application

• Proposed studies are highly significant
• Addresses important questions
• Potential for providing valuable insights
• Solid foundation for proposed studies
• Novel concepts

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Options If Not Funded

• Revise and Resubmit (2 Chances)
• Funding Outside the Payline
• Exception, Shannon, Private Foundations,
  Supplementary Support (Competing Renewal)
• Program Directors Advice
• Scientific Review Administrators Advice
• Give up (I hope not!)

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Revision

• Introduction 3 pages
• Diplomacy thank the reviewers
• State concerns fully and provide response

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Introduction Format

• Concerns by Reviewers and Response
• Reviewer 1
• - Concern 1
• - Response 1
• Reviewer 2
• - Concern 1
• - Response 1

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Other Funding Organizations

• Other Government Agencies Cancer Research
• Department of Defense Funding Initiatives
• Office of Orphan Products Development (FDA)
• Veterans Health Administration

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Private Foundations

• American Cancer Society
• Burroughs Wellcome Fund
• The Charlotte Geyer Foundation
• Damon Runyon Cancer Research Foundation
• Robert Wood Johnson Foundation

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Summary

• NIH/NCI Grant Funding is becoming highly
  competitive
• Applications should be prepared with utmost
  diligence and insight
• The help and advice of SRAS at CSR, program
  officers at the institutes, and colleagues at
  your institution who have been successful will
  provide an added advantage in crafting an
  outstanding application

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Questions Answers
Martin Padarathsingh, Ph.D. Referral Officer
Scientific Review Administrator Center for
Scientific Review/NIH Research Proposal
Consultant, H. Lee Moffitt Cancer Center
Research Institute