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					K30 Module 1:
 NIH Grant
Preparation
         Goals of this Module

• Familiarize you with the grant writing
  and submission process
  Logistics of preparing an application
  Submitting it through the institution
  The review process at the NIH
  Considering non-NIH funding sources
   Preparing an NIH Grant:
       An Introduction


Leslie J. Raffel, MD
Associate Director
Common Disease Genetics Program
Cedars-Sinai Medical Center
Program Director
Cedars-Sinai General Clinical Research Center
http://report.nih.gov/index.aspx
Funding and the Young Investigator in
the Current Era
The problem:
• Most academic faculty are expected to bring
  in their own research support within 2-3 years
  of appointment as an Assistant Professor

• Obtaining funding is hard, especially for new
  investigators without a funding track record

• In a tight fiscal environment (NIH funding
  levels are approaching single digits at some
  institutes) funding is harder than ever
The Money
                          Type                               FY 2008 Actual
                          Research Project Grants       $15,654,000,000
                          Research Centers                 $2,944,000,000
                          Other Research Grants            $1,780,000,000
                          Research Training                      $770,000,000
                          R&D Contracts                    $3,270,000,000
                          Intramural Research              $3,074,000,000
                          Research Mgmt & Support          $1,373,000,000
                          All Other                        $1,520,000,000

                                                      $30,385,000,000

NIH Extramural Data Book – last update May 2008     Data provided by the Division of Information Services, Reporting Branch   NEDB 7
                                                                  Total NIH budget authority




                                FY 2008 actual          FY 2009 enacted




NIH Extramural Data Book – last update May 2008   Data provided by the Division of Information Services, Reporting Branch   NEDB 8
                                     NIH Budget Authority FY 1977 – FY 2007
                      (Current vs. Constant 1977 Dollars Using BRDPI as the Inflation Factor)
                                               (Dollars in Billions)
$30


$25
                                                Current Dollars
                                                Constant Dollars
$20


$15


$10


 $5


 $0




                                                                                                                                                                                                                        2007 Est.
      1977
             1978
                    1979
                           1980
                                  1981
                                         1982
                                                1983
                                                       1984
                                                              1985
                                                                     1986
                                                                            1987
                                                                                   1988
                                                                                          1989
                                                                                                 1990
                                                                                                        1991
                                                                                                               1992
                                                                                                                      1993
                                                                                                                             1994
                                                                                                                                    1995
                                                                                                                                           1996
                                                                                                                                                  1997
                                                                                                                                                         1998
                                                                                                                                                                1999
                                                                                                                                                                       2000
                                                                                                                                                                              2001
                                                                                                                                                                                     2002
                                                                                                                                                                                            2003
                                                                                                                                                                                                   2004
                                                                                                                                                                                                          2005
                                                                                                                                                                                                                 2006
                                                                                                                                                                       NIH Statistics 2006
                                                                             R01-Equivalent grants
                                                                                     Average size




NIH Extramural Data Book – last update May 2008   Data provided by the Division of Information Services, Reporting Branch   NEDB 10
The Chance of Getting
      Funded
                                                                                      R01-Equivalent grants
                                                                     Applications, awards, and success rates




                                                  26%
                                                                                                                   19%




                             * R01-Equivalent Grants include R01, R23, R29, and R37 mechanisms
NIH Extramural Data Book – last update May 2008                          Data provided by the Division of Information Services, Reporting Branch   NEDB 12
                                                          R01-Equivalent grants, New (Type 1)
                                                  Success rates, by career stage of investigator




NIH Extramural Data Book – last update May 2008             Data provided by the Division of Information Services, Reporting Branch   NEDB 13
FY         New Applications &        Success Rate
           Amendment Status
2008   First (Original) Submission              8.4%
2008      First Amendment (A1)                 31.7%
2008    Second Amendment (A2)                  55.0%
2008     Third Amendment (A3)                  33.3%
2008              TOTAL                        19.0%
2007   First (Original) Submission              8.4%
2007      First Amendment (A1)                 30.4%
2007    Second Amendment (A2)                  55.4%
2007     Third Amendment (A3)                  44.4%
2007              TOTAL                        19.2%
2006   First (Original) Submission              7.9%
2006      First Amendment (A1)                 27.8%
2006    Second Amendment (A2)                  46.9%
2006     Third Amendment (A3)                  43.8%
2006              TOTAL                        16.3%
2005   First (Original) Submission             10.1%
2005      First Amendment (A1)                 30.6%
2005    Second Amendment (A2)                  48.3%
2005     Third Amendment (A3)                  50.0%
2005              TOTAL                        17.9%
2004   First (Original) Submission             13.1%
2004      First Amendment (A1)                 35.5%
2004    Second Amendment (A2)                  48.8%
2004     Third Amendment (A3)                 100.0%
2004              TOTAL                        20.0%
Fate of unamended (unsolicited) R01
     research grant applications
Fiscal    Number     Number         Total $    Success
Year     submitted   awarded       awarded       rate
                                   (millions)     (%)
         Type-1 grants: new submissions
1999       8957         1761         456         19.7
2000       8626         1736         503         20.1
2001       8284         1590         501         19.2
2002       8560         1556         510         18.2
2003       9605         1477         493         15.4
2004      10624         1288         438         12.1
2005      10605          970         351           9.1
 Type-2 grants: c ontinuation (rene wal) submissions
1999       3214         1772         554         55.1
2000       3233         1708         563         52.8
2001       3100         1637         583         52.8
2002       3153         1555         559         49.3
2003       3767         1697         627         45.0
2004       3773         1530         580         40.6
2005       3896         1262         496         32.49
                        Mandel & Vesell, Science 313: 1387 - 1388, 2006
                                                                      R01-Equivalent investigators
                                                  Number supported, by career stage of investigator




NIH Extramural Data Book – last update May 2008                  Data provided by the Division of Information Services, Reporting Branch   NEDB 16
                                                Average Age




                  32
                       33
                            34
                                 35
                                      36
                                           37
                                                  38
                                                        39
                                                               40
                                                                       41
                                                                                 42
                                                                                      43
                                                                                           44
                                                                                                45
              19 70
              19 71
              19 72
              19 73




                                                              MD-PhD
              19 74
              19 75
              19 76
              19 77
              19 78
              19 79
              19 80
              19 81
              19 82
              19 83
              19 84
              19 85
              19 86
              19 87
              19 88
              19 89
                                                                                                                                    Award




Fiscal Year
              19 90
              19 91
              19 92
                                                                            MD




              19 93
                                                  PhD




              19 94
              19 95
              19 96
              19 97
              19 98
              19 99
              20 00
              20 01
              20 02
                                                                                                     Average Age of New Investigators at the Time of Intial R01 Equivalent




              20 03
              20 04
              20 05
              20 06
                                     Age Distribution of NIH RPG Investigators
                                           and Medical School Faculty
                                                        1980
                               7%




                               6%




                               5%
    Percent of PIs / Faculty




                               4%




                               3%                                                           NIH RPG PIs
                                                                                            Med School Faculty (AAMC)

                               2%




                               1%




                               0%
                                    25   30   35   40   45   50       55         60   65   70     75      80      85      90

                                                                           Age
Sources: IMPAC II Current and History Files and AAMC Faculty Roster        NIH OFFICE OF EXTRAMURAL RESEARCH
                                                                                                                   September 2007
                                           Age Distribution of NIH RPG Investigators
                                                 and Medical School Faculty
                                                              2006
                                 7%




                                 6%
                                                  1980

                                 5%
      Percent of PIs / Faculty




                                 4%




                                 3%                                                           NIH RPG PIs
                                                                                              Med School Faculty (AAMC)

                                 2%




                                 1%




                                 0%
                                      25     30   35     40   45   50   55         60   65   70     75      80      85      90

                                                                             Age
Sources: IMPAC II Current and History Files and AAMC Faculty Roster           NIH OFFICE OF EXTRAMURAL RESEARCH
                                                                                                                      September 2007
Funding and the Young Investigator

The good news:
• The NIH is aware of the problem and is
  committed to improving the situation
• There are new funding programs specifically
  for young investigators
• There are institute commitments to support
  success rates for young investigators
New Extramural Principal Investigators




                   FIRST
                                                                       Check box




Note: As of December 3, 2007 the FY 2007 New Investigator Numbers are Preliminary
Career Development
    (K) Awards
Number of NIH K Awards
  Fiscal Years 1996 - 2006
Average NIH Individual K Award Size
                 Fiscal Years 1996 - 2006




Excludes program Awards: K12 and K16
      Distribution by Average Number of NIH K
                   Awards by Activity
                                Fiscal Years 1996 - 2006
4,500                                                                                                                        KL2
                                                                                                                             KL1
                                                                                                                             K99
4,000                                                                                                                        K30
                                                                                                                             K26
3,500                                                                                                                        K25
                                                                                                                             K24
3,000                                                                                                                        K23
                                                                                                                             K22
2,500                                                                                                                        K21
                                                                                                                             K20
                                                                                                                             K18
2,000                                                                                                                        K17
                                                                                                                             K16
1,500                                                                                                                        K15
                                                                                                                             K14
1,000                                                                                                                        K12
                                                                                                                             K11
                                                                                                                             K08
  500                                                                                                                        K07
                                                                                                                             K06
  -                                                                                                                          K05
                                                                                                                             K04
          96 997 998 999 000 001 002 003 004 005 006 007                                                                     K02
        19 1     1   1   2   2   2   2   2   2   2   2                                                                       K01



 Competing applications for K04, K11, K14, K15, K16, K17, K20 and K21 were discontinued in FY 1995. Information on current
 K awards can be found at: http://grants.nih.gov/training/careerdevelopmentawards.htm .
                                                  Research Career Development Awards
                                                         Number of entry-level awards




NIH Extramural Data Book – last update May 2008      Data provided by the Division of Information Services, Reporting Branch   NEDB 26
Trends in Number of Individual NIH K Awards
            by Institute or Center
           Fiscal Years 1998 - 2007
       For Individuals with Research Degrees
      Distribution by Average Number of NIH K
                   Awards by Activity
                                Fiscal Years 1996 - 2006
4,500
4,000                                                                                                                        K30
                                                                                                                             K26
                                                                                                                             K25
3,500                                                                                                                        K24
                                                                                                                             K23
3,000                                                                                                                        K22
                                                                                                                             K21
2,500                                                                                                                        K20
                                                                                                                             K17
                                                                                                                             K16
2,000                                                                                                                        K15
                                                                                                                             K14
1,500                                                                                                                        K12
                                                                                                                             K11
1,000                                                                                                                        K08
                                                                                                                             K07
                                                                                                                             K06
 500                                                                                                                         K05
                                                                                                                             K04
  -                                                                                                                          K02
                                                                                                                             K01
         96

         97

         98

         99

         00

         01

         02

         03

         04

         05

         06
      19

      19

      19

      19

      20

      20

      20

      20

      20

      20

      20
 Competing applications for K04, K11, K14, K15, K16, K17, K20 and K21 were discontinued in FY 1995. Information on current
 K awards can be found at: http://grants.nih.gov/training/careerdevelopmentawards.htm
Research Degree
K02   Provides support for newly independent scientists who
      need a period of intensive research focus as a means of
      enhancing their research careers
K01   For scientists switching to a substantially new health-
      related research field:
      • background in bio-medicine, OR
      • had a hiatus in career because of illness or family care
        responsibilities, OR
      • delayed completion of training to serve as faculty at a minority
        serving university
K25   Scientist switching to a biomedically-related research field
      AND whose background is in a quantitative science (e.g.
      mathematics or statistics)
F32   Scientist continuing with similar postdoctoral training
                  Health Professional Degree
      Distribution by Average Number of NIH K
                   Awards by Activity
                                Fiscal Years 1996 - 2006
4,500
4,000                                                                                                                        K30
                                                                                                                             K26
                                                                                                                             K25
3,500                                                                                                                        K24
                                                                                                                             K23
3,000                                                                                                                        K22
                                                                                                                             K21
2,500                                                                                                                        K20
                                                                                                                             K17
                                                                                                                             K16
2,000                                                                                                                        K15
                                                                                                                             K14
1,500                                                                                                                        K12
                                                                                                                             K11
1,000                                                                                                                        K08
                                                                                                                             K07
                                                                                                                             K06
 500                                                                                                                         K05
                                                                                                                             K04
  -                                                                                                                          K02
                                                                                                                             K01
         96

         97

         98

         99

         00

         01

         02

         03

         04

         05

         06
      19

      19

      19

      19

      20

      20

      20

      20

      20

      20

      20
 Competing applications for K04, K11, K14, K15, K16, K17, K20 and K21 were discontinued in FY 1995. Information on current
 K awards can be found at: http://grants.nih.gov/training/careerdevelopmentawards.htm .
Health Professional Degree

K23 Professional has completed specialty or sub-
    specialty training and is seeking salary and
    research support for a full-time supervised
    career development experience in patient-
    oriented research (POR)

K08 Professional seeking salary and research
    support for a full-time supervised career
    development experience in area of health-
    related research that does not involve patients
NIH Success Rates for Selected K
           Activities
       Fiscal Years 1996 - 2008
NIH Success Rates for Selected K
           Activities
       Fiscal Years 1996 - 2008
Applications and Awards by Institute or Center, FY 2007

                                               NIH K08




                                                NIH K23
NIH is attempting to assist new investigators

New Investigator: An NIH research grant
Program Director/Principal Investigator (PD/PI)
who has not yet competed successfully for a
substantial, competing NIH research grant is
considered a New Investigator.

A PD/PI who has received a Small Grant (R03)
or an Exploratory/Developmental Research
Grant Award (R21) retains his or her status as
a New Investigator.

http://grants1.nih.gov/grants/new_investigators/index.htm
Examples of current NIH Institute and Center
practices to foster new investigator independence:

   Practices vary by Institute, but may include:
   • First-time R01 investigators given an
     extended percentile payline
     (generally 5% greater than regular payline)
   • Additional funds are being allocated to pay
     eligible applications beyond this extended
     payline as exceptions
   • Funding new investigators for all years
     requested
Early Stage Investigator (ESI): An
individual who is classified as a New or
First-Time Investigator and is within 10
years of completing his/her terminal
research degree or is within 10 years of
completing medical residency (or the
equivalent) is considered an Early Stage
Investigator (ESI).
New Investigators as well as ESIs will be eligible
for the “Full Implementation to Shorten the
Review Cycle for New Investigator R01
Applications Reviewed in Center for Scientific
Review (CSR) Recurring Study Sections”


       http://grants.nih.gov/grants/guide/notice-
       files/NOT-OD-07-083.html
• Study Sections participating will schedule meetings
  so that new investigators receive their summary
  statements no later than March 1, July 1, or
  November 1.
• The Summary Statements for qualifying applications
  will have an explicit note indicating eligibility for next
  cycle submission.
• Resubmission applications for consideration at the
  next cycle must be submitted by March 20, July 20,
  or November 20.
• New Investigators who do not choose the next cycle
  option will use the standard resubmission dates for
  subsequent cycle submission (March 5, July 5, or
  November 5).
                                January 27, 2006
     NIH Announces Program to Foster the
     Independence of New Investigators

     National Institutes of Health Director Elias
     A. Zerhouni, M.D. announced today the NIH
     Pathway to Independence Award Program.

     The program features a new opportunity for
     promising postdoctoral scientists to receive
     both mentored and independent research
     support from the same award.


http://grants.nih.gov/grants/new_investigators/index.htm
NIH Pathway to Independence Award Program
                    K99
   • NIH will issue between 150 and 200 awards for this
     program in its initial year, beginning in Fall 2006
       183 awards given out in 2007
      180 awards given out in 2008
   • The agency expects to issue the same number of
     awards each of the following five years.
   • During this time, the NIH will provide almost $400
     million in support of the program.
   • All NIH Institutes and Centers are participating in
     this award program.
NIH Pathway to Independence Award Program
                    K99

  Eligibility:
     – Outstanding postdoctoral candidates who
       have a clinical or research doctorate
       (including Ph.D., M.D., D.O., D.C., N.D.,
       D.D.S., D.V.M., Sc.D., D.N.S., Pharm.D. or
       equivalent doctoral degrees)
     – No more than 5 years of postdoctoral
       research training at the time of application
NIH Pathway to Independence Award Program
                    K99
The award will work as follows:
The initial 1-2 year mentored phase will allow
investigators to complete their supervised research
work, publish results, and search for an independent
research position. $90,000/year
The second, independent phase, years 3-5, will allow
awardees who secure an assistant professorship, or
equivalent position, to establish their own research
program and successfully apply for an NIH
Investigator-Initiated (R01) grant. $250,000/year
http://grants.nih.gov/grants/new_investigators/index.htm
         NIH Loan Repayment Programs

In exchange for a two or three-year (for Intramural
General Research) commitment to your research
career, NIH will repay up to $35,000 per year of your
qualified educational debt.
In addition, the NIH will make corresponding Federal
tax payments for credit to your Internal Revenue
Service tax account at the rate of 39% of each loan
repayment to cover your increased Federal taxes.
The NIH may also reimburse any increased state or
local taxes and/or additional increased Federal taxes
(where the Federal tax payments were not sufficient to
fully cover your increased Federal taxes) that you incur
as a result of your LRP benefits.
        The 5 Loan Repayment Programs

   • Clinical Research
   • Pediatric Research
   • Health Disparities Research
   • Clinical Researchers from Disadvantaged Backgrounds
   • Contraception and Infertility Research


DEADLINES: Extramural LRP Applications: December 1, 2009

                    http://www.lrp.nih.gov/
The Basic Eligibility Requirements for NIH
      Loan Repayment Programs:

 • Doctoral-level degree
 • Government research funding (Federal, state or
   local) or domestic nonprofit research funding
 • Student loan debt equal to at least 20% of annual
   salary
 • U.S. citizenship or permanent residency
 • Non-Federal government job
                                         September 24, 2008

Elias A. Zerhouni stepped down as NIH Director

                                             August 17, 2009

Francis S. Collins, M.D., Ph.D., sworn as the 16th NIH director




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