WRITING A GRANT AS A YOUNG INVESTIGATOR Kay Ryan Director, Clinical Research

WRITING A GRANT AS A YOUNG
INVESTIGATOR
Kay Ryan
Director, Clinical Research
Operations
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
Foundations
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@partners.org)
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_ResearchMgmt/RM_Conta
cts_MGH.asp
Tips
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:
MD
R03
T35
Medical
Student MD
T32
or
F32
Clinical
Training
K08
or
K23
K22
R21
R01 K02 K24 R37
Faculty
Position
T35 - short-term, health prof students
T32 - Institutional Training Grant
F32 - Individual Postdoctoral Fellowship
K08 - Mentored Clinical Scientist Dev’t Award
K23 - Mentored Clinical Research Dev’t Award
K22 - Research Scholar Dev’t Award
*R03 – Small Grant *R21 – Exploratory Grant
Independent
PI
K02 - Independent Scientist
Award
K24 - Mid-Career Investigator
Award Clinical Research
R37 - Merit Award
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
Know your NIH Institute!
• Look at NIH Institute-specific websites
(for example www.niddk.nih.gov )
• Learn Institute’s research priorities
• Look at Institute’s application success
rates (# applications; # awards):
http://grants1.nih.gov/grants/award/success.htm
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
“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
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 Patientoriented 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
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
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
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
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
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
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
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@LIST.NIH.GOV
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
LOIs
They’re Not Easy !
If I had more time, I would have written
you a shorter letter.
Mark Twain
Acknowledgements
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.
End