Things You Need to Know When You Prepare Your...
Transcript of Things You Need to Know When You Prepare Your...
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Things You Need to Know When You Prepare Your NIH Grant Application: S
Focus on K Awards Part III
John S. Adams, M.D.
Director, Orthopaedic Hospital Research Center
Associate Director, Clinical and Translational Research Institute
Departments of Orthopaedic Surgery, Medicine and Molecular, Cell & Developmental Biology
UCLA
Regenerative Musculoskeletal Medicine
Training Program (T32)
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Part I
• Getting to know the NIH
– Funding trends
• The submission process
– Timeline
– New page and formatting rules
• The NIH peer-review process
• Ten commandments of grant writing
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Part II
• Ten commandments of grant writing
• Your resubmission
– Analyzing your summary statement
– Writing your “Introduction”
– “Dos” and “Don’t’s”
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Part III Agenda
• Getting to know the NIH
– Funding trends: emphasis on K grants
• The submission process
– Timeline
– New page and formatting rules
– K grant-specific guidelines
• Ten commandments of grant writing
• Resubmission “Dos” and “Don’t’s”
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On-line Resources for Trainees • Applying Electronically:
http://grants.nih.gov/grants/ElectronicReceipt/index.htm • Career Development Chapter of NIH GPS:
http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch12.htm#_Toc271265177
• K Kiosk – NIH Career Development Awards (includes links
to all K FOAs): http://grants1.nih.gov/training/careerdevelopmentawards.htm
• Career Award Wizard: http://grants1.nih.gov/training/kwizard/index.htm • Questions:
Henry Khachaturian: [email protected] or
Marcia Hahn: [email protected] or
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The Current Timelines “What to expect and when to expect it”
Months 0 1 5 4 3 2 8 7 6 9
OCT NOV MAR FEB JAN DEC JUN MAY APR JUL
Submission to OER
CSR gives SRG, I/C
and PD assignment
SRG review
supplementary material to SRO
score resubmission
Council
revision
summary
statement
K
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Restructured Applications as of 2/2010
• 5.1. Introduction (1 page max)
• 5.2. Specific Aims (1 page max)
• 5.3. Research Strategy (6 or 12 pages)
– Significance
– Investigator(s)
– Innovation
– Approach
• Preliminary Studies/Progress Report
• Experiments
– Environment
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K Grant Applications as of 2/2010
• Biosketch (4 pages max)
• Introduction (1 page max)
• Specific Aims (1 page max)
• Research Strategy (6 pages)
– Significance
– Investigator(s)
– Innovation
– Approach
• Preliminary Studies/Progress Report/Experiments
– Environment
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K Grant Applications (cont’d)
• Training in the responsible conduct of research (1 page max)
• Mentoring plan (6 pages max)
– Includes didactic training (CTSI)
• Mentor statements (6 pages max)
• Institutional environment (1 page)
• Institutional and mentor commitment to candidates research career development (1 page)
• Appended reference letters
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FY 2012 Budget: $31.987 Billion
Research Project Grants:53.0%
Intramural Research:
10.0%
R&D Contracts:11.0%
Research Centers:
10.0%
Career Dev. 2.1%
Other Research:3.5%
All Other:2.0%
Research Mgmt & Support:
5.0%
Research Training:
2.5%
~$794 M Training
~$652 M Career
~$1.43 Billion
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21%
22%
25%
26%27%
26%27%
27%
25%
21%
19%
17%
18%
19%
17%
17%19%
21%
24%
25%25%
26%26%
25%24%
20%
18%
16%
19%
19%
18%19%
19%
21%
23% 22% 22% 22%21% 21%
17%
16%15%
19%
18%
18%
17%
0%
5%
10%
15%
20%
25%
30%
35%
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Su
cc
ess
Ra
te
Success Rates for New (Type 1) Applications,Including First-time R01 Award
Research Project Grants (Type 1)
R01 Equivalent (Type 1) Awards
First-time R01 Equivalent Award
Success Rates
17%
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Success Rate for K Grants Still High (last 14 years; up to 2011)
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Research Training and Career Development Timeframe
Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30)
Postdoctoral Institutional Training (T32) Postdoctoral Individual NRSA (F32)
Independent Scientist Award (K02)
Senior Scientist Award (K05)
Career Stage ‘Formal’ Training/Career Awards
GRADUATE/ MEDICAL STUDENT
POST DOCTORAL
EARLY
MIDDLE
SENIOR
CA
RE
ER
Predoctoral Institutional Training Grant (T32)
NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25)
Midcareer Investigator Award in Patient-Oriented Research (K24)
PRE-BAC Pre-Bac Institutional Training Grant (T34)
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Mentored K Awards
• KO1: Mentored Research Scientist Development Award
• KO8: Mentored Clinical Scientist Development Award for Laboratory Research
• K22: Research Career Award for Transition to Independence
• K23: Mentored Patient-Oriented Research Development Award
• K99/R00: NIH Pathway to Independence Award
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Success Rate of K01 Awards
0
100
200
300
400
500
600
700
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Fiscal Year
App
licat
ions
and
Aw
ards
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Succ
ess
Rat
e
Reviewed Awarded Success Rate
15
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Success Rate of K08 Awards
16
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K08 Awardees’ Subsequent Application for and Receipt of NIH
RPGs*
17
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Success Rate of K23 Awards
18
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K23 Awardees’ Subsequent Application for and Receipt of NIH RPGs
19
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Success Rate of K99 Awards
20
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Mentored K Grant Common Features Eligibility
• Requires doctoral degree
• Some require clinical degree (e.g., Ko8, K23)
• Previous NIH PD/PI on an Ro3/R21 okay
• Must be US citizen or permanent resident (except for K99/R00) at the time of award
• Must have a full-time appointment
• Must commit 75% effort to grant
– Can be 50% for some, many surgical specialties
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Mentored K Grant Common Features Duration
• 3-5 years
– K99 phase of K99/Roo generally 2 years
• Mentor team best
• Encouraged to apply for R grants during K
• With approval from NIH, can reduce effort to 50% for maximum of 12 months
• With approval from NIH, are transferrable to another institution as long as mentor plan intact
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Mentored K Grant Common Features Costs
• Can vary across NIH I/Cs (review I/C PAs)
• Salaries
– $75,000 to $XXX,XXX depending on award and specialty
– salary supplements are okay but must come from non-federal source and cannot be compensation for work that infringes on 75%
– Fringe benefits are over and above salary
– Indirects limited to 8%
• Research and development costs
– $25,000-$50,000 for supplies, equipment, travel, etc.
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Mentored K Grant Common Features Application
• Electronically submitted using SF424
• Check Funding Opportunity Announcement (FOA)
– I/Cs vary in their use of K awards
• Submission dates
– New: February, June, October 12
– Resub/Renewal: March, July, November 12
• Goes directly from OER to I/C, not CSR, for review
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The NIH Peer Review Process
CSR I/C
OER
most R grants SBIRs
some PAs some RFAs
PPGs training (T & F) grants
K grants some PAs and RFAs
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Mentored K Awards: Review Criteria in order of priority
• Candidate
• Career development plan
• Research plan
• Mentor(s), consultant(s) and collaborator(s)
• Environment and institutional commitment to the candidate
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Today’s Agenda
• Getting to know the NIH
– Funding trends: emphasis on K grants
• The submission process
– Timeline
– New page and formatting rules
– K grant-specific guidelines
• Ten commandments of grant writing
• “Dos” and “Don’t’s”
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Ten Commandments
For Writing Sections 5.1-5.3
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Tablet 1 Tablet 2
I. Thou shall have a testable hypothesis in a “hot” area
II. Thou shall have short and concise specific aims
III. Thou shall be an expert in the literature of your topic
IV. Thou shall not “cut-and paste”
I. Thou shall acknowledge
pitfalls and alternative plans
VI. Thou shall use pictures to tell your story
VII. Thou shall provide a reasonable timeline
VIII. Thou shall have “zero tolerance” for errors
IX. Thou shall put yourself in the
shoes of the reviewer
X. Thou shall use your grant writing mentor or advisor(s)
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“One Picture Can Be Worth a Thousand Words”
mitochondria
CYP27B1
1,25-D
25-D
DBP
24,25-D
CYP24
1 2 3
5
4
6
VDR
7
serum macrophage
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Tablet 1 Tablet 2
I. Thou shall have a testable hypothesis in a “hot” area
II. Thou shall have short and concise specific aims
III. Thou shall be an expert in the literature of your topic
IV. Thou shall not “cut-and paste”
I. Thou shall acknowledge
pitfalls and alternative plans
VI. Thou shall use pictures to tell your story
VII. Thou shall provide a reasonable timeline
VIII. Thou shall have “zero tolerance” for errors
IX. Thou shall put yourself in the
shoes of the reviewer
X. Thou shall use your grant writing mentor or advisor(s)
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Your Resubmission Do:
• Follow SF424 instructions precisely.
• Assume all of the initial study section comments were correct.
• Respond to all criticisms.
• Assume the same reviewer(s) will be seeing your revised application. – try to identify “your reviewer(s)” from the summary
statement roster
– write the resubmission with your reviewers’ research/expertise in mind
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• assume you’re smarter than your reviewers
• argue with the reviewers in your response
• leave out a consideration of any criticism, regardless of how “minor” it might seem to you
• fail to have your colleague and/or mentor review your revision before resubmission
• fight with your: – grants and contract officer
– IRB office
– IACUC representative
Your Resubmission Do Not:
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Your Resubmission Fatal Flaws
• Not marking points of revision in your resubmission
• Writing a “non-responsive” Introduction
• Writing an antagonistic (i.e. condescending) Introduction
• Resubmitting before you have the additional preliminary data requested
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�
This series of presentations will be available on the UCLA
Orthopaedic Surgery Regenerative Musculoskeletal Medicine
Training Program Website
http://ortho.ucla.edu/body.cfm?id=243