1. WRITING A GRANT AS A YOUNG INVESTIGATOR Kay Ryan Director, Clinical Research Operations MGH Clinical Research Program January 29, 2008

2. 1. Resources for Clinical Investigators 2. Tips 3. Grants for starting Investigators NIH Training Grants NIH Career Development Awards Foundations Today’s Goals

3. 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)

4. 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

5. 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

6. Federal Grants for Different Career Stages: MD T35 T32 or F32 K08 or K23 K22 R01 K02K24R37 MD Faculty Position Medical Student Clinical Training Independent PI 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 K02 - Independent Scientist Award K24 - Mid-Career Investigator Award Clinical Research R37 - Merit Award R03R21

7. 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

8. Know your NIH Institute! Look at NIH Institute-specific websites (for example www.niddk.nih.gov )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

9. 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 http://grants.nih.gov/training

10. “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

11. 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.)

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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)

20. 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

21. 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

22. LOIs They’re Not Easy ! If I had more time, I would have written you a shorter letter. Mark Twain

23. 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.

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