CTSI R Workshop: A Tactical Approach to Writing Your Grant Application
William Parks, PhD
Professor of Medicine at Cedars-Sinai Medical Center and UCLA
Associate Dean for Graduate Research Education
Scientific Director, Women’s Guild Lung Institute
A Tactical Approach to Writing Your Grant Application - 2023
1. William Parks, PhD
Department of Medicine
Cedars-Sinai Medical Center
A Tactical Approach to
Preparing Your Grant Application
2. Topics
• Emphasis on an NIH R01 Submission
• Preparation and Timelines
• Reviewers and Review Criteria
• Investigator Criterion – Preparing Your Biosketch
• Presentation Tips
Institute Assignment
Study Section
Assignment
You ➜ ➜ ➜ CSR ➜ ➜ Reviewers ➜ Back to You
OCGA
ORA
Grant
Admin
3. My Central Recommendations
• Read other grants – both successful and unsuccessful
• Become familiar with the grant-submission process, rules, and deadlines
Both NIH and Your Institution’s Rules
• Give yourself plenty of time
• Get as much admin stuff – letters, budget, forms etc. – done or lined up early
• Get feedback from your mentor, committee, other faculty, your peers, and
this and other workshops
5. How to Submit your Application
1. Be familiar with NIH forms, etc.
2. Identify your group’s grant administrator
3. Tell this person that you plan to submit an R01 for Feb 2024
•Do this 2-3 months – if not longer – ahead of the due date
•Important: You are not the only one submitting a grant
4. Email your documents to your grant admin person
• Get the easy stuff done early (coming up)
5. Grant admin uploads components and builds application
6. Institution uploads to grants.gov
6. Grant Preparation: NIH Things to do Well in Advance
• Familiarize yourself with NIH grants, forms, instructions, and due dates
• All grants: https://grants.nih.gov/grants/guide/parent_announcements.htm
• NIH Forms: http://grants.nih.gov/grants/forms.htm
• Page Limits: http://enhancing-peer-review.nih.gov/page_limits.html
• Due Dates: http://grants1.nih.gov/grants/funding/submissionschedule.htm
• Instructions and more: https://grants.nih.gov/grants/how-to-apply-application-guide.html
• Know what Institute to target and what they are in interested in
• RFA, Program announcements, etc.: https://grants.nih.gov/funding/searchguide/index.html#/
• By Institutes: http://www.nih.gov/icd/
• Know your competition
• RePORT (Research Portfolio Online Reporting Tools): http://report.nih.gov/
• Database of all NIH grants, success rates, and much more
Good video on some grant preparation tips:
http://www.youtube.com/watch?v=lAOGtr0pM6Q
8. Instructions
Download Research Instructions
Go here: https://grants.nih.gov/grants/how-to-apply-application-guide.html
Other Useful Sites
• How to apply videos: https://grants.nih.gov/grants/how-to-apply-application-guide/video/index.htm
• Portal to lots of info: https://www.nih.gov/grants-funding
• Fellowship kiosk: https://researchtraining.nih.gov/programs/career-development
10. Current Forms, PA, Review Criteria, etc. – A Useful Site
https://grants.nih.gov/grants/guide/parent_announcements.htm
All Grants:
11. NIH Dates for New (A0) R01s in 2024
Feb 5 Jan 29 June Sept Dec
June 5 May 29 Oct Jan Apr
Oct 5(7) Sept 30 Feb May July
• OCGA* (UCLA) or ORA** (CS) submits your application to Grants.gov
• Your submission deadline to them is 5 (UCLA) or 3 (CS) business days
before the NIH due date.
*Office of Contract and Grant Administration
**Office of Research Administration
NIH Due Dates
NIH
Submission
Due Date
UCLA
Due Date#
Study
Section
Review
Council
Review
Funding
Begins
UCLA Due Dates #Estimates; actual dates
are posted quarterly
12. Timeline for a Feb 5, 2024, Deadline
Dec
2024
Funded!
Good
Score
Submit Reviewed
Think
Plan
Data
Write
Feedback
Re-write
Admin Stuff
Feb (Jan)
2024
Summer/Fall
2023
Oct to Jan
2023/24
Jun
2024
13. Timeline for a Feb 5, 2024, Deadline
Oct
2024
Feb
2025
Jul
2025
Funded!
Fair
Score
Resubmit
Re-
reviewed
Realistically a 2-year + Process
Good
Score
Submit
Think
Plan
Data
Write
Feedback
Re-write
Admin Stuff
Critique
2-3 weeks later
Reviewed
Feb (Jan)
2024
Summer/Fall
2023
Oct to Jan
2023/24
Jun
2024
14. Grant Preparation - Things to do Well in Advance
• Give yourself plenty of time
• Formulate your ideas and think
• Testable hypothesis that advances a field
• Present your ideas and aims to your colleagues
• Do this more than once
• Know the literature & be critical
• Issues and controversies
• What gaps will your work fill
• Generate preliminary data
• Support all hypotheses
• Confirms feasibility
• Publish
• The importance of this cannot be stressed enough
• Read successful applications!
• Seek advice
• Enlist collaborators, consultants
• Special reagents, techniques, advice
• Obtain letters
• Take care of the administrative stuff
• Budgets
• Human subjects, animals, biohazards, etc.
15. R01 Grant Sections
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
16. R01 Grant Sections You Prepare or Obtain
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
17. R01 Grant Sections That are Easy
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
18. R01 Sections That Do Not Differ That Much Among Applications
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
19. R01 Grant Sections That Require the Most Effort
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
20. NIH Grant Review Process
How Your Application is Evaluated
What Matters to the Reviewers
Institute Assignment
Study Section
Assignment
You ➜ ➜ ➜ CSR ➜ ➜ Reviewers ➜ Back to You
OCGA
ORA
Grant
Admin
22. NIH Institutes and Year Established
http://www.nih.gov/icd/
Office of the Director
AIDS Research
Women’s Health
National Institute
on Alcohol Abuse
and Alcoholism
1970
National Inst of
Arthritis, Musculo-
skeletal & Skin Dis
1986
National
Cancer
Institute
1937
National Institute
of Diabetes and
Digestive and
Kidney Diseases
1950
National Institute
of Dental and
Craniofacial
Research
1948
National Institute
on Drug Abuse
1974
National Institute
of Environmental
Health Sciences
1969
National Institute
on Aging
1974
National Institute
of Child Health
and Human
Development
1962
National Institute
on Deafness and
Other Communi-
cation Disorders
1988
National Eye
Institute
1968
National Human
Genome Research
Institute
1989
National Heart,
Lung, and Blood
Institute
1948
National Institute
of Mental Health
1949
National Institute
of Neurological
Disorders and
Stroke
1950
National Institute
of General
Medical Sciences
1962
National Institute
of Nursing
Research
1986
National Library
of Medicine
1956
Center for
Information
Technology
1964
Center for
Scientific Review
1946
National Center
for Complementary
& Integrative Health
1999
National Institute
of Allergy and
Infectious Diseases
1948
Fogarty
International
Center
1968
National Center
for Advancing
Translational
Sciences
2011
Clinical Center
1953
National Institute
of Biomedical
Imaging
& Bioengineering
2000
National Center
on Minority
Health and Health
Disparities
2010
23. Who’s Responsible for Review of Your Application?
F Series
CSR
K Series
Institutes
RPGs
(R01s, R21s)
CSR
Big Grants
Centers, T32,
Program Projects
Institutes
• All use the same mechanism and structure
• Peer-review at a Study Section
Training/Career Grants
Institute Specific Councils $$
24. The Fate and Evaluation of Your Proposal
Pretty dull and needlessly long video of this topic
http://www.youtube.com/watch?v=DuuAGROm_1Q&feature=relmfu
Your can influence this process
Institute Assignment
Study Section
Assignment
You ➜ ➜ ➜ CSR ➜ ➜ Reviewers ➜ Back to You
• Suggest Institute assignment
• Suggest Study Section
• Identify conflicts
• Identify areas of needed expertise
• Do not recommend specific reviewers
PHS
Assignment
Form
OCGA
ORA
Grant
Admin
25. Who Do You Call?
• Institute based
• Before submission
• After initial (study section)
review
• Has influence on funding
• Tracks progress
Program Officer (PO) Scientific Review Officer (SRO)
• CSR (mostly) or institute based
• During initial review stage
• Has no influence on funding
PO SRO
Submit
to NIH
Grant Preparation
Resubmit
to NIH
2nd
Review
Funded
1st
Review
PO
26. Study Sections
• CSR: Center for Scientific Review
• ~50,000 applications per year (77% of all applications)
• Study Sections (>200)
Organ or disease focused
• ~24 members per study section essentially
all from academia
• 40-90 applications per Study Section meeting
• 3 reviewers per applications
• 10-12 applications per member (>240 pages)
• Information at the CSR web site
• Study section scope and policies
• Roster of reviewers
• Schedules
• Study sections are advisory - they do not fund applications.
• More videos: https://public.csr.nih.gov/NewsAndPolicy/PeerReviewVideos
28. How Your Application is Scored and Ranked
1. Criterion Scores
2. Overall Impact Score – this is the one that matters
Two Components
29. Scored Review Criteria
Individual Training
F-series Grants
• Candidate
• Career development plan
Career goals and objectives
Plan to provide mentoring
• Research Plan
• Mentor(s), consultants, collaborators
• Environment &
Institutional commitment
Career Development
K-series Grants
Investigator Initiated
R-series Grants
• Significance*
• Investigator*
• Approach*
• Innovation
• Environment
Focus on training potential Focus on the science and you
*Most important
• Candidate
• Training Potential
• Research Plan
• Mentor(s), consultants, collaborators
• Environment &
Institutional commitment
30. Scored Review Criteria – R Proposals
Overall Impact or
Criterion Strength
Score Descriptor
High
1 Exceptional
2 Outstanding
3 Excellent
Moderate
4 Very Good
5 Good
6 Satisfactory
Low
7 Fair
8 Marginal
9 Poor
• Criterion Score
• Whole numbers: 1-9
• 1 (exceptional); 9 (um, well let’s just hope you never get a 9)
• Significance
• Investigator
• Approach
• Innovation
• Environment
31. Scored Review Criteria – R Proposals
Overall
Impact
Overall Impact or
Criterion Strength
Score Descriptor
High
1 Exceptional
2 Outstanding
3 Excellent
Moderate
4 Very Good
5 Good
6 Satisfactory
Low
7 Fair
8 Marginal
9 Poor
• Criterion Score
• Whole numbers: 1-9
• 1 (exceptional); 9 (um, well let’s just hope you never get a 9)
• Overall Impact Score
• Not the mean of the criteria scores – but within their range
• Different criteria are weighted by each reviewer
• Significance
• Investigator
• Approach
• Innovation
• Environment
32. Scored Review Criteria – R Proposals
Overall
Impact
Overall Impact or
Criterion Strength
Score Descriptor
High
1 Exceptional
2 Outstanding
3 Excellent
Moderate
4 Very Good
5 Good
6 Satisfactory
Low
7 Fair
8 Marginal
9 Poor
• Criterion Score
• Whole numbers: 1-9
• 1 (exceptional); 9 (um, well let’s just hope you never get a 9)
• Overall Impact Score
• Not the mean of the criteria scores – but within their range
• Different criteria are weighted by each reviewer
• Significance
• Investigator
• Approach
• Innovation
• Environment
4
2
4
6
2
2-6
33. Scored Review Criteria – R Proposals
Overall
Impact
Overall Impact or
Criterion Strength
Score Descriptor
High
1 Exceptional
2 Outstanding
3 Excellent
Moderate
4 Very Good
5 Good
6 Satisfactory
Low
7 Fair
8 Marginal
9 Poor
• Criterion Score
• Whole numbers: 1-9
• 1 (exceptional); 9 (um, well let’s just hope you never get a 9)
• Overall Impact Score
• Not the mean of the criteria scores – but within their range
• Different criteria are weighted by each reviewer
• Final Impact Score, Percentile
• Mean of all scores x 10 ➤ 10 – 90
• Percentiled against all applications across 3 meetings
• Significance
• Investigator
• Approach
• Innovation
• Environment
35. Review Process - Before the Meeting
• Applications available about 6 weeks before meeting (all via web)
• Scores and critiques are uploaded 1 week before study section
• Each criterion is given a score: 1, 2, 3…9 (outstanding to really bad)
• These are not discussed at the Study Section
• But they are included in the Summary Statement you will get
• Each reviewer gives each application an overall Impact Score (1-9)
• Impact Score is not the mean of the criteria scores
• Impact Score is key, and the only score discussed
• Initial scores and critiques become available to all committee members
• Based on the initial impact scores by the 3 reviewers, bottom 50% are not discussed
36. The Review Process - at the Meeting
Good video of a mock Study Section
https://www.youtube.com/watch?v=fBDxI6l4dOA
• Review Grants - random order
• Assigned reviewers state their initial impact scores: 1, 2, 3…9
• 1˚ reviewer, 2˚, 3˚, then open for discussion
• Human subj, vertebrate animals, etc.
• All members vote (score)
• Budget, others
• Final Impact Score = (Mean of all scores) x 10
• Expressed as a % of all scores over 3 meetings
• 15-20 min per application
• Begin at 8 am EST (i.e., 5 am PST)
• Cramped room full of laptops and several
jet-lagged reviewers
38. Review Criteria – Useful Links
https://grants.nih.gov/policy/peer/reviewer-guidelines.htm
https://grants.nih.gov/grants/guide/parent_announcements.htm
All Grants
Rigor & Reproducibility
https://grants.nih.gov/policy/reproducibility/index.htm
https://grants.nih.gov/grants/peer/guidelines_general/R
eviewer_Guidance_on_Rigor_and_Transparency.pdf
Documents and Instructions for Reviewers
39. Current Forms, PA, Review Criteria, etc. – A Useful Site
https://grants.nih.gov/grants/guide/parent_announcements.htm
All Grants:
Read these sections
R01
40. R01 Grant Sections
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
41. R01 Grant Sections Reviewers Care About
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
42. R01 Grant Sections Reviewers Really Care About
• Face Page
• Table of Contents
• Performance Site
• Project Description: Abstract
• Project Narrative: 2 sentences
• References Cited
• Facilities and Other Resources
• Equipment
• Key Personnel
• Biosketches
• Budget (all years)
• Budget Justification
• Introduction
(resubmission only)
• Specific Aims
• Research Strategy
• Significance
• Innovation
• Approach
• Protection of Human Subjects
• Women & Minorities
• Planned Enrollment Table
• Children
• Vertebrate Animals
• Select Agents
• Multiple PI Plan
• Letters of Support
• Resource Sharing
• Authentication of Key
Biological and/or Chemical
Resources
• PHS Assignment Form
43. Review Criteria - Investigator
• Early Stage Investigators (ESI)
• More emphasis on experience and training
• Publications are important but not critically so
• ESIs get a bit of break with productivity
– but just a bit
• Quality and relevance of publications are important criteria
• Reality: Numbers and quality do matter.
Your competition may have more.
• Pay line handicap varies by institute
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-101.html
https://grants.nih.gov/policy/early-investigators/index.htm
44. ESI Success Rates – a Bit Lower?
New
Established
No difference by gender
46. Review Criteria - Investigator
• Not a review criterion
• Does not affect scoring
• Cannot even be discussed
NIH/CSR Rules
Independence
Reality
• However, it is in the reviewer’s mind
• If you remain associated with your mentor, include a letter
from him/her confirming your independence
• My Advice: Do not include your mentor as key personnel
• Do not say your lab space is in their lab space
• Get a letter from your chair indicating commitment to you
48. Formatting
• For all sections you prepare
• MS Word.docx
• 0.5-in margins
• 11 pt Arial
• No header or footer
• Submit to grant admin as PDFs
Guide: https://grants.nih.gov/grants/how-to-apply-application-guide.html#format
Fonts: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm
Page Limits: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm
• Facilities and Other Resources
• Budget Justification
• Introduction (resubmission only)
• Specific Aims
• Research Strategy
• Human Subjects pages
• Vertebrate Animals
• References Cited
• Multiple PI Plan
• Resource Sharing
• Authentication of Key Biological and/or
Chemical Resources
49. Presentation and Style
• Zero tolerance for tpyos
• Avoid excessive use of abbreviations
• Avoid vague terms: e.g., ‘affects’, ‘influences’
• Avoid pleonasms: “…has been shown to…”
• Clean, concise English
• Active voice is better than the passive voice
• Simple, clear language
50. Presentation and Style
• Paragraphs and spaces
• Don’t make it look dense or cluttered
• Zero tolerance for tpyos
• Avoid excessive use of abbreviations
• Avoid vague terms: e.g., ‘affects’, ‘influences’
• Avoid pleonasms: “…has been shown to…”
• Clean, concise English
• Active voice is better than the passive voice
52. Presentation and Style
• Paragraphs and spaces
• Don’t make it look dense or cluttered
• Flow
• Logical transitions from sentence to sentence, paragraph to paragraph
• Do the work for your reader
• Use some system (bold, numbers) to outline sections and
subsections
•Again, read successful applications
• Zero tolerance for tpyos
• Avoid excessive use of abbreviations
• Avoid vague terms: e.g., ‘affects’, ‘influences’
• Avoid pleonasms: “…has been shown to…”
• Clean, concise English
• Active voice is better than the passive voice