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    Kay Ryan
    Director, Clinical Research
    MGH Clinical Research Program

    January 29, 2008
              Today‟s Goals
1. Resources for Clinical Investigators

2. Tips

3. Grants for starting Investigators
     NIH Training Grants
     NIH Career Development Awards
    Resources for Clinical Investigators
MGH Clinical Research Program
• CRP faculty mentors (Genomic/Genetic research;
  Outcomes/Epidemiology research; Biostatistical &
  study design issues)

•    IRB submission consultation and advice

• Implementing clinical studies; budgeting clinical
  studies; locating funding sources

•    Help with NIH and other federal submissions

Contact: Kay Ryan (
              More Resources
• PHS Human Research Committee (HRC)
 Guidelines, Forms, Certification, etc
 Advice: Maria Sundquist, PHS HRC
          Denise McCauley, MGH Clinical Research Program

• Research Management
 Staff contacts, Forms, Policies, Deadline
1. Identify at least 2 potential funding
   sources for every project idea

2. Don‟t rely on federal funding; check
   foundation databases

3. Anticipate a re-submission

3.   Prepare a Letter of Intent (LOI)
     LOIs – used by foundations & feds

4. Start writing early, identify mentors/reviewers
      Federal Grants for Different Career Stages:
                                         R03       R21

                      T32    K08
                      or     or
     T35              F32    K23                R01 K02 K24 R37

 Medical         Clinical                             Independent
 Student MD      Training               Faculty            PI
                                                K02 - Independent Scientist
T35 - short-term, health prof students
T32 - Institutional Training Grant
                                                K24 - Mid-Career Investigator
F32 - Individual Postdoctoral Fellowship
                                                         Award Clinical Research
K08 - Mentored Clinical Scientist Dev‟t Award
                                                R37 - Merit Award
K23 - Mentored Clinical Research Dev‟t Award
K22 - Research Scholar Dev‟t Award
*R03 – Small Grant *R21 – Exploratory Grant
         NIH Career Development
          Programs (“K” Awards)

• 14 Different Mechanisms
• articulate with Career Stage:
    Mentored, Mid-career, Senior
• interact with other NIH Awards
• use “K Kiosk” or “Career Award Wizard”:

Note: Not every NIH institute offers K awards
    Know your NIH Institute!

• Look at NIH Institute-specific websites
  (for example )
• Learn Institute‟s research priorities
• Look at Institute‟s application success
  rates (# applications; # awards):
       NIH Career Development
        Programs (“K” Awards)

• 14 Different Mechanisms
• articulate with Career Stage:
    Mentored, Mid-career, Senior
• interact with other NIH Awards
• use “K Kiosk” or “Career Award Wizard”:
        “Career” or K-series Awards

• designed to “protect” time, i.e., free up time
  currently spent in clinic or on administrative
  or teaching duties
• most are for early career development
• provide „salary‟ not „stipend‟
• meant to train U.S. citizens/permanent
  – K99 is an exception to this policy
• limited to U.S. research/clinical institutions
   Career Development (K-series) Awards

• K01 – Mentored Research Scientist Development
  Award (Ph.D.)- usually basic research
• K08 – Mentored Clinical Scientist Development
  Award (M.D. or other clinical degree)- usually basic
• K99/R00 – Pathway to Independence (PI) Awards
• K23 – Mentored Patient-oriented Research Career
  Development Award (M.D. or other clinical degree)
• K22- Transition Award- 2-3 years at NIH; 2-3 years
  at extramural academic institution in U.S.
• K24 – Mid-Career Investigator Award in Patient-
  oriented Research (M.D.)
    Career Development Mechanisms Aimed
         Primarily at Clinical Scientists

• Mentored Clinical Scientist Career Development
  Award (K08)
  – usually apply toward the end of fellowship
  – 2-5 years of training in research
  – up to $75,000 per year in salary, up to $25,000
    per year in research-related costs
  – 3-5 year award
  – traditionally, not necessarily, basic research
      Career Development Mechanisms
     Primarily Aimed at Clinical Scientists

• Mentored Patient-Oriented Career Development
  Award (K23)
  – encourage career development of physician
    scientists in clinical research
  – Senior Postdoctoral fellows
  – up to $75,000 per year in salary, and $25,000-
    $50,000 per year in research-related costs
  – 3-5 year award
   Mentored Clinical Scientist Development
               Awards (K08/K23)

• mentor-based, bridge to independence
• discrete research plan with plan for
• this is NOT Post-Doctoral training
• should have finished clinical training
• Institutional support (promotion to Instructor?)
• minimum 75% effort
• 3-5 years of support
• may also apply for (and receive!) R01 grant
  while holding a K award
         NIH Application Resources

• Sample K award applications:
• K08:
• K23:
             NIH Pathway to
    Independence (PI) Awards (K99/R00)

– provides up to 5 years of support in two
– K99: Provides an intensive, mentored
  research experience for up to 2 years
– R00: Independent scientist phase; transition
  to research independence as junior faculty
  (up to 3 years of support)
  • move to different Institution is generally the goal
     Mentored Clinical Scientist Career
     Development Award (K08/K23/K99)

• Essential components of grant application:
  – career development plan must be carefully
     • may include coursework
     • may work toward a graduate degree
  – mentorship must be strong and appropriate
  – Institutional commitment to career
    development must be clear
                   R-series grants

• R01s – Research project grants unsolicited and in
  response to Funding Opportunity Announcements
  (e.g. PAs and RFAs)
• R21s – Exploratory/Developmental grants usually
  only in response to FOAs
• R03s – Small grants only in response to FOAs

Subscribe to NIH Guide – weekly announcement of
  NIH funding opportunities:
    The Letter of Intent (LOI)
Used by federal agencies/foundations
  – Filter applications to their interest area
  – Appoint appropriate reviewers

Specific to the agency, typically ask for
 - Abstract
 - NIH CV /Biosketch
 - Nomination letter (some, but not all)
Writing an LOI- Start Early
• Limited to 2 to 3 pages
  – Title of proposal
  – Abstract ( ~ 200 words)
  – Background of applicant (or NIH Biosketch)
  – Objectives
  – Methodology
  – Statistical analysis plan
  – Key references
LOI can help you
• crystallize the essence of the project
• organize key references
• get “spring loaded” to submit well
  thought out project in short time frame

Scope of work can be adjusted to funding
They‟re Not Easy !

If I had more time, I would have written
you a shorter letter.
                           Mark Twain
Recent Extensive Presentations by
• William F. Crowley, Jr. , MD
  How to write a $ucce$$ful NIH grant

• Janet E. Hall, MD
  Writing your first investigator initiated grant as a
  Young Investigator

Available on CRP website.

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