WRITING A GRANT AS A YOUNG INVESTIGATOR

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WRITING A GRANT AS A YOUNG INVESTIGATOR
Kay Ryan Director, Clinical Research
Operations MGH Clinical Research Program January
29, 2008
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Todays Goals
1. Resources for Clinical Investigators 2.
Tips 3. Grants for starting Investigators NIH
Training Grants NIH Career Development
Awards Foundations
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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 (kryan10_at_partners.org)

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More Resources

• PHS Human Research Committee (HRC)
• Guidelines, Forms, Certification, etc
• http//healthcare.partners.org/phsirb/home.htm
• Advice Maria Sundquist, PHS HRC
• Denise McCauley, MGH Clinical
  Research Program
• Research Management
• Staff contacts, Forms, Policies, Deadline
• http//phsresearchintranet.partners.org/PHS_Resea
  rchMgmt/RM_Contacts_MGH.asp

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Tips

• Identify at least 2 potential funding
• sources for every project idea
• 2. Dont 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

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Federal Grants for Different Career Stages MD
T32 or F32
K08 or K23
K22
K02
K24
R37
T35
R01
Independent PI
Medical Student
Clinical Training
Faculty Position
MD
K02 - Independent Scientist Award K24 -
Mid-Career Investigator Award Clinical
Research R37 - Merit Award
T35 - short-term, health prof students T32 -
Institutional Training Grant F32 - Individual
Postdoctoral Fellowship K08 - Mentored Clinical
Scientist Devt Award K23 - Mentored Clinical
Research Devt Award K22 - Research Scholar Devt
Award R03 Small Grant R21 Exploratory
Grant
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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
• http//grants.nih.gov/training
• Note Not every NIH institute offers K awards

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Know your NIH Institute!

• Look at NIH Institute-specific websites (for
  example www.niddk.nih.gov )
• Learn Institutes research priorities
• Look at Institutes application success rates (
  applications awards)
• http//grants1.nih.gov/grants/award/success.ht
  m

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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
  http//grants.nih.gov/training

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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 residents
• K99 is an exception to this policy
• limited to U.S. research/clinical institutions

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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 research
• 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.)

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Career Development Mechanisms Aimed Primarily at
Clinical Scientists

• Mentored Clinical Scientist Career Development
  Award (K08)
• usually apply toward the end of fellowship
  training
• 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

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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

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Mentored Clinical Scientist Development Awards
(K08/K23)

• mentor-based, bridge to independence
• discrete research plan with plan for independence
  
• 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

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NIH Application Resources

• Sample K award applications
• K08 http//www.nhlbi.nih.gov/funding/training/red
  book/k08model.htm
• K23 http//www.nhlbi.nih.gov/funding/training/red
  book/k23models.htm

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NIH Pathway to Independence (PI) Awards
(K99/R00)

• provides up to 5 years of support in two phases
• 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

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Mentored Clinical Scientist Career Development
Award (K08/K23/K99)

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

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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
• email NIHTOC-L_at_LIST.NIH.GOV

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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)

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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

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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

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LOIs

• Theyre Not Easy !
• If I had more time, I would have written
• you a shorter letter.
• Mark Twain

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Acknowledgements

• Recent Extensive Presentations by
• William F. Crowley, Jr. , MD
• How to write a ucceful NIH grant
• Janet E. Hall, MD
• Writing your first investigator initiated grant
  as a Young Investigator
• Available on CRP website.

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End