WRITING A GRANT AS A YOUNG INVESTIGATOR

Kay RyanDirector, Clinical Research OperationsMGH Clinical Research Program

January 29, 2008

1. Resources for Clinical Investigators

2. Tips

3. Grants for starting Investigators

NIH Training Grants

NIH Career Development Awards

Foundations

Today’s Goals

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_Contacts_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

T35

T32or F32

K08or K23

K22 R01 K02 K24 R37

MD FacultyPosition

MedicalStudent

ClinicalTraining

IndependentPI

T35 - short-term, health prof studentsT32 - Institutional Training GrantF32 - Individual Postdoctoral FellowshipK08 - Mentored Clinical Scientist Dev’t AwardK23 - Mentored Clinical Research Dev’t AwardK22 - Research Scholar Dev’t Award*R03 – Small Grant *R21 – Exploratory Grant

K02 - Independent ScientistAward

K24 - Mid-Career Investigator Award Clinical Research

R37 - Merit Award

R03 R21

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 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 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/redbook/k08model.htm

• K23: http://www.nhlbi.nih.gov/funding/training/redbook/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, MDWriting your first investigator initiated grant as a Young Investigator

Available on CRP website.

End