NIH Grant Proposals and the Study Section Process

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NIH Grant Proposals and the Study Section Process

• W. Conrad Liles, MD, PhD
• Professor and Vice-Chair of Medicine
• Director, Division of Infectious Diseases
• University of Toronto

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NIH Grant Proposals and the Study Section Process

• NIH Organizational Structure
• NIH Grant Categories
• Time Lines
• Study Sections
• Scoring
• Putting Together the Research Plan
• Revised Applications

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NIH Study Section

• Scientific Review Administrator
• NIH administrative official
• Chairman
• Committee
• Meets for 2 day sessions 3x/yr
• 70-110 grant applications/session
• 20-25 members
• Approx 15-20 regular members (4-5 yr term)
• 5-10 ad hoc reviewers/cycle
• Each member is assigned 6-10 grants to
  review/cycle
• Primary reviewer
• Secondary reviewer
• Reader

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NIH Study Section

• Each of the 3 reviewers writes a written review
  and assigns a preliminary priority score
  (range1.0-5.0)
• Mean priority scores are calculated prior to
  meeting and lower 50 of scored applications are
  triaged
• No priority score assigned
• Written critiques (pink sheets) provided
• Primary reviewer responsible for a scored grant
  presents the grant and leads the discussion
  (w/Chairman) 10-30 minutes
• Priority score range established
• Other committee members vote
• Final priority score determined

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NIH Grant Proposals and the Study Section Process

• NIH Organizational Structure
• NIH Grant Categories
• Time Lines
• Study Sections
• Scoring
• Putting Together a Career Development Award
• Revised Applications

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NIH Study Section

• Priority Score 100-500
• Percentile rank the important score
• Payline (funding level)
• Varies according to grant type
• Varies according to Institute
• Varies according to Congressional budget

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NIH Grant Proposals and the Study Section Process

• NIH Organizational Structure
• NIH Grant Categories
• Time Lines
• Study Sections
• Scoring
• Putting Together a Career Development Award
• Revised Applications

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Research Plan25 pages total

• Specific Aims 1 page
• State scientific goal
• 3-4 specific aims
• Divide each into 2-4 distinct sub-aims
• State long-term objective
• Background and Significance - 4-5 pages
• Be concise and logical
• Include diagrams, etc. as appropriate
• Divide into discrete concepts with subheadings
• Supportive reference documentation
• Preliminary Studies 5-6 pages
• Extremely important
• Provide rationale and feasibility for your
  research plan
• Divide into discrete concepts with subheadings
• Include figures, graphs, etc.

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Research Plan25 pages total

• Research Design and Methods 10-12 pages
• Divide into Specific Aims and Sub-aims
• Each Sub-aim
• Hypothesis
• Rationale
• Experimental Approach
• Data Analysis
• Anticipated Results, Potential Problems, and
  Alternative Approaches
• Research Methods and Protocols
• Summary of Research Program
• Include Timeline in tabular format
• Emphasize significance and importance of
  results/findings
• Future directions
• Translational Research

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Research Plannot included in 25 pages total

• Human Subjects
• Vertebrate Animals
• References
• List of consultants

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Research PlanTips

• Text must be logical, easy-to-read, and
  well-written
• Grant must appeal to reviewer within the first
  page
• Use diagrams and tables
• Avoid page after page of text only and unbroken
  paragraphs
• Do not fill up every space on every page
• Use Arial font 11
• Include letters from all consultants and
  individuals who supply needed reagents, animals,
  etc
• Justify numbers of human subjects/animals for
  each aim (power analysis)

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NIH Grant Proposals and the Study Section Process

• NIH Organizational Structure
• NIH Grant Categories
• Time Lines
• Study Sections
• Scoring
• Putting Together the Research Plan
• Revised Applications

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Revised Applications

• Should I re-submit?
• Role of Program Officer and/or Scientific Review
  Administrator (SRA)
• Dont take criticism on the pin sheets
  personally
• In revision, address the critiques in a
  point-by-point fashion
• Be specific in how the grant application has been
  revised in response to the critiques
• Highlight the changes in the text of the revised
  application
• Do not express disgust directed towards previous
  review

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Revised Applications

• Usually a properly revised application will be
  scored more favorably
• However, your revised grant may or may not
  receive a higher score
• Your revised application may or may not be
  reviewed by the same individuals
• Discretion of Chair and SRA
• Maximum of 2 revisions (3 submissions) allowed
  for R grants

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Other Issues

• Direct costs vs. indirect costs?
• What is an RFA?
• Equipment?
• Secretarial/administrative support?