NIH and New and Early Stage Investigators

1. NIH and New and Early Stage Investigators Michael A. Sesma, Ph.D. National Institute of General Medical Sciences

2. Let’s review… the first steps in developing a competitive application • Get to know the NIH Program Director for your scientific area • Contact them about your research ideas • Fit with institute mission and priorities • Best grant mechanism or program for you • Best study section for review • Technical assistance with the application process • Are you a New or Early Stage Investigator? • Programs for transition to independence and for NI/ESI

3. Who is a New Investigator or An Early Stage Investigator? • A New Investigatoris a Principal Investigator who has not previously competed successfully as a PD/PI for a“significant independent” NIH research grant. • Significant Independent NIH research grant = R01 • An Early Stage Investigatoris a PD/PI within 10 years of their terminal degree or clinical residency training and has not yet previously competed successfully as PD/PI for a “significant independent” NIH research grant. http://grants.nih.gov/grants/new_investigators/index.htm

4. Who are the NIH New Investigators?

5. Grant Programs for Career Transitions and Newly Independent Investigators • Career Transition Award Programs: • K22; K99/R00; K12 • Mentored Career Development Awards: • K01; K08; K23; K25 • Programs for Newly Independent Faculty: • R03; R21 • High Risk, High Reward Programs: • NIH Director’s New Innovator Award • NIH Director’s Early Independence Award • NIH Research Project Grant: R01 • New Investigator Initiatives • And the Loan Repayment Program

6. Career Transition Award – K22 • K22: NCI, NHLBI, NIAID, NIDCR, NIMH, NINDS, NIEHS • To support mentored, non-independent investigators in transitioning to their first independent tenure-track faculty research position (or equivalent) • For Postdoctoral investigators in the NIH Intramural Program or at domestic institutions • Support for 3-5 years • NCI: Transition Career Development Award – within 2 years of first independent cancer research position (PAR-12-121; Diversity PAR-12-062) • NIAID: Research Scholar Development – no more than 5 years of postdoctoral training – apply as a postdoctorate – grant awarded when in a tenure-track position (PAR-12-156)

7. Career Transition Awards – K99/R00 K99/R00 NIH Pathway to Independence (PI) Award To facilitate timely transition from mentored postdoctoral research position to stable independent research position with independent NIH or other research support at an earlier stage than is currently the norm. • K99-Mentored phase- support to obtain additional mentored training, complete research, publish results, and bridge to an independent research position.  • R00 Independent phase- research grant to establish an independent research program and prepare application for regular research grant support (R01).  PA-14-042:http://grants.nih.gov/grants/guide/pa-files/PA-14-042.html • For individuals with less than 4 years postdoctoral training • Project Period: K99 - up to 2 years; R00 - up to 3 years • Budget and Duration: see specific NIH Institute and Center • Non-citizens are eligible

8. Institutional Career Development - K12 Mentored Clinical Scientist Development Program Awards (K12) grant to an institution for the development of independent clinical scientists: NCI: Paul Calabresi Career Development Award for Clinical Oncology (K12) (PAR-13-201) NEI: The NEI Mentored Clinical Scientist Development Program Award (K12) (PAR-12-002) NIDA: NIDA Mentored Clinical Scientists Development Program Award in Drug Abuse and Addiction (K12) (PAR-13-163) NINDS: Neurological Sciences Academic Development Award (K12) (PAR-13-362) NIGMS: Institutional Research and Academic Career Development Awards (IRACDA) (K12) (PAR-13-290)

9. Mentored Career Development Awards Grants provide support for “protected time” (3-5 years) for an intensive, mentored career development experience to facilitate launch of independent research careers and enhance competitiveness for new research project grant (R01) • K01 Mentored Research Scientist Development Award • For investigators in the biomedical, behavioral or clinical sciences to supports intensive research career development under the mentorship of an established researcher. • K08 Mentored Clinical Scientist Research Career Development Award • for individuals with a clinical doctoral degree to support an intensive, mentored research career development experience in the fields of biomedical and behavioral research, including translational research.  • K23Mentored Patient-Oriented Research Career Development Award • For investigators seeking to focus on Patient-Oriented research, i.e., “research conducted with human subjects (or on material of human origin including cognitive phenomena) for which an investigator directly interacts with human subjects.” • K25 Mentored Quantitative Research Development Award • For investigators from quantitative science and engineering research backgrounds seeking to to integrate their expertise with NIH-relevant research.  http://grants.nih.gov/training/careerdevelopmentawards.htm

10. Review Criteria for Career Development Awards Candidate Career Development Plan Goals and Objectives Research Plan Mentor(s), Co-mentor(s), Consultants, Collaborators Environment & Institutional Commitment to Candidate Review Criteria compared: http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf

11. Non-Mentored Career Development Awards Career Development Grants used by some ICs to advance investigators early in their independent careers • K02 (PA-14-045) • FIC: Independent Scientist in Global Health Award – within 7 years of last doctoral degree or fellowship • NINDS: Independent Scientist Award – years 1-3, salary, fringe, and supplies – years 4-5: if the applicant obtains an R01 or equivalent grant, salary and fringe • K07 (PA-11-192) • NCCAM and NIAAA: Academic Career Award (Development Award) – for more junior investigators who are interested in developing academic and research expertise

12. Small Grants (R03) for New Investigators NIAMS: Small Grant Program For New Investigators NIDCD: Small Grant Program – within 7 years of degree or fellowship NIDCR: Small Grant Program for New Investigators NIDDK: Small Grant Program for NIDDK K01/K08/K23 Recipients NIDA: Behavioral Science Track Award for Rapid Transition (B/START)(I/START) $50K per year, 2 years, non-renewable

13. Research Grant Programs to Consider • NIDCR:Small Research Grants for Data Analysis and Statistical Methodology applied to Genome-wide Data (R03) • “Investigators who have not previously received funding from NIDCR as a Principal Investigator are encouraged to apply.” • NIDA: Early Career Award in Drug Abuse & Addiction (ECHEM) - R21/R33 • A Phased Innovation grant for new-to-NIH, newly independent investigators and investigators without previous NIH funding to conduct basic chemistry research applied to drug abuse and addiction and relevant to the NIDA’s Mission. • The R21 is a research grant mechanism, but not a new investigator grant • NIAID:“New investigators who feel unready to compete for an R01 are using the R21 successfully to gather preliminary data for their R01 applications.” • NIAMS:“Projects that will be considered a lower priority include new investigator starter grants.” • NIDDK:“R21s should NOT be used by new investigators to gather preliminary data for a standard R01.” • NINDS:“FY 2009 success rates for NINDS R21 New Investigators: 11% vs. NINDS R01 New Investigators: 19%”

14. NIH Director’s High Risk High Impact Awards for New Investigators • New Innovator Award • Early Stage Investigators proposing high potential, impact research • Unusual flexibility in pursuing research objectives • Up to $1.5M for 5 years • Early Independence Award • Junior Investigators within 12 months of doctoral degree and ready for research independence • Up to $1.25M for 5 years • Institutions may actively recruit eligible EIA candidates http://commonfund.nih.gov/highrisk

15. NIH Director’s Early Independence Award (EIA) What’s Novel? Institution may actively recruit eligible EIA candidates New PhD or MD locates an institution willing to host • Must be within 12 months before or after graduation • Must demonstrate exceptional creativity, maturity, management skills • Research relevant to NIH mission • Strong letters of recommendation • Institution ensures independent lab space/supplies/staff space/staff/equipment • Appointment up to 5 years • Protected research time for development as researcher • Proposed research complements and enhances institution’s programs • Institution may choose to retain candidate

16. Age of Early Stage Investigators at first major independent research award, and Awardees of programs to facilitate transition to independence

17. NIH R01 Grant – The Gold Standard The NIH Research Project Grant (R01): • The original and historically oldest grant mechanism used by NIH. • Support for research relevant to the mission of the NIH. • Investigator-initiated or response to a specific Funding Opportunity Announcement (FOA). • Support for a discrete, specified, circumscribed project conducted by the named investigator(s) in an area representing the investigator's specific interest and competencies. • R01 grants awarded to organizations of all types. The Principal Investigator/Project Director writes application, is responsible for conducting the research. The applicant is the research organization. • Awarded for 1-5 years with a budget justified by the proposed work.

18. Implementation of NI/ESI policies • At Study Section, NI/ESI R01 applications are identified to reviewers so that appropriate consideration of their career stage can be applied during review.  • NI/ESI applications are “clustered” during review to enable evaluation as a group and distinguish from Established Investigators. • Multi-PI projects are identified for consideration of NI/ESI status only if ALL of the listed PIs qualify as NI/ESI. • Staff in the NIH institutes and centers are apprised of NI/ESI status, which may be considered when applications are selected for award.  • NI/ESI applicants are eligible for the “Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections”. • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html • Update notice: NOT-OD-11-057.html

19. New Investigator R01 Initiatives • New Investigators/Early Stage Investigators (NI/ESI) R01 applicationsreceive special attention at Council as high program priority or equivalent. • Flexible paylinefor NI/ESI scored R01 applications. • No imposed reductions in duration and amount of awards (beyond the recommendations of the initial review group) for NI/ESI. • Fund NI/ESI R01 applications to achieve a designated success rate rather than setting a specific payline. • Supporting ESI R01s for five years (many Institutes fund R01 for 4 years for established PIs) • Partial “bridge” funding http://grants.nih.gov/grants/new_investigators/

20. IC specific Strategies for NI/ESI Applications • NHLBI: priority funding for the first competitive renewal. (1) The individual cannot be a principal investigator on an Independent Scientist and/or other non-mentored career award or on another R01 or a sub-project director on a multi-project award, and (2) must be currently holding a position at a domestic institution with a faculty rank up to and including an Associate Professor or equivalent. • NIAAA: ESIs just beyond the nominal payline are invited to submit a letter to respond to the summary statement critiques. Responses reviewed by Program staff, and when deemed appropriate, the application may be recommended to Institute Director for award. • NICHD: Special funding consideration will be given to research project grant applications submitted by new investigators supported by NICHD Career Development Awards (Ks).

21. Let’s review… the first steps in developing an competitive application • Get to know the NIH Program Director for your scientific area • Contact them about your research ideas • Fit with institute mission and priorities • Best grant mechanism or program • Best study section for review • Technical assistance with the application process • Are you a New/Early Stage Investigator? • Consider the R01 Grant

22. Loan Repayment Program • Commit to perform research for 2 years, and the NIH repays up to $35,000 per year of your qualified educational debt and covers the resulting taxes. • You must be conducting research in of the following 5 areas: • Clinical Research • Pediatric Research • Contraception & Infertility Research • Health Disparities Research • Clinical Research for Individuals from Disadvantaged Backgrounds http://www.lrp.nih.gov/

23. To Reiterate… Get to know the Program Director for your scientific area!

24. Grant Writing for Success Writing the Application • Start early and develop good ideas • Seek advice and critical input from colleagues • Talk to your NIH Program Official(s) • Use the NIH and OER webpage resources • http://grants.nih.gov • Follow instructions carefully, remember review criteria • Submit your application

25. Questions? msesma@nigms.nih.gov