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