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)

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

Part II

• Ten commandments of grant writing

• Your resubmission

– Analyzing your summary statement

– Writing your “Introduction”

– “Dos” and “Don’t’s”

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”

5

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: hk11b@nih.gov or

NIHTrain@mail.nih.gov

Marcia Hahn: hahnm@mail.nih.gov or

GrantsPolicy@od.nih.gov

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

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

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

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

10

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

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%

Success Rate for K Grants Still High (last 14 years; up to 2011)

13

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)

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

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

Success Rate of K08 Awards

16

K08 Awardees’ Subsequent Application for and Receipt of NIH

RPGs*

17

Success Rate of K23 Awards

18

K23 Awardees’ Subsequent Application for and Receipt of NIH RPGs

19

Success Rate of K99 Awards

20

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

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

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.

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

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

26

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

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”

Ten Commandments

For Writing Sections 5.1-5.3

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)

“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

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)

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

• 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:

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

�

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