NRSA Fellowships (F) & Training (T) Grants

1. Overview of NIH Research Training and Career Development ProgramsHenry Khachaturian, Ph.D.NIH Extramural Program Policy OfficerActing NIH Research Training OfficerOffice of Extramural Research, NIHEmail: hk11b@nih.gov

2. NRSA Fellowships (F) & Training (T) Grants Individual Dual Degree Fellowship (F30) Individual Postdoc Fellowship (F32) Individual Predoc Fellowship (F31) Individual Senior Fellowship (F33) • Principal Investigator • Team Scientist Undergraduate Grad or Med School Postdoc or Residency Institutional Training Grant (T32) Short-Term Institutional Training Grant (T35)

3. NRSA Eligibility and Regulations • Must be Citizen, non-citizen national, or lawfully admitted for permanent residence. • NRSA Fellows: Individual Fellowships (F) • NRSA Trainees: Institutional Training (T) Grants. • Predoctoral Fellows and Trainees: Must have a baccalaureate degree & be enrolled in doctoral program leading to Ph.D., comparable research doctoral degree or dual research/clinical doctorate like the M.D./Ph.D. • Postdoctoral Fellows and Trainees: Must have a Ph.D. or M.D. or comparable doctoral degree from an accredited domestic or foreign institution. • Duration of Support: 5 years (Predoc) and 3 Years (Postdoc) in aggregate.

4. Individual NRSA Fellowships: Overview • Individual Fellow applies through University/Institution. • Up to 5 years (Predoctoral) and 3 years (Postdoctoral) of support; service payback obligation for Postdoctoral Fellows and Trainees. • Research & training plans; potential to become an independent investigator. • Annual progress reports • Stipend: Not salary; subsistence allowance to help defray living expenses. • Fellow not an employees of either Government or University.

5. Individual NRSA Fellowships: Mechanisms • F30: Individual predoctoral fellowship for MD/PhD or other dual-degree training. Applicants must show potential to become productive, independent physician-scientists. • F31: Individual predoctoral fellowship. Provide support for promising doctoral candidates (dissertation phase) in research fields relevant to the missions of the NIH. • F31: Individual predoctoral fellowship to promote diversity in research. Provide support for training leading to the PhD or MD/PhD degree (or equivalent). • F32: Individual postdoctoral fellowship. Provide support to applicants with potential to become productive, independent research investigators. • F33: Individual senior fellowship. Provide support to experienced scientists who wish change research direction or broaden their research capabilities.

6. NRSA Fellowship Review Criteria • Candidate: Academic and research record; potential for, and commitment to, a productive scientific research career. • Sponsor/Mentor and Training Environment: Experience and qualifications of mentor for proposed research training and successful competition for research support; Quality of training environment and institutional commitment to training; Availability of facilities/resources; and funding. • Research Training Proposal: Merit of the proposal; Quality of research training plan; Training as foundation for candidate’s productive career. • Training Potential: Value of the proposed fellowship experience as it relates to the candidate's needs in preparation for a career as an independent researcher. • Training in the Responsible Conduct of Research: Applicants are encouraged to creatively tailor a plan to meet own needs in relation to proposed research training.

7. Helpful Hints for Fellowships • Read the Program Announcement and Contact NIH staff. • Read the Instructions in the application kit. • Give yourself and your sponsor enough time. • Give references enough time. • Training should be appropriate considering previous experience. • Project should have merit as research and as training mechanism. • Capable and experienced Sponsor(s)? Collaborator(s)? Consultant(s) • Same training site? • Observe application limitations. • Arrange for pre-review.

8. Fellowship Application • Use PHS 416-1: Paper Application. • Transition to electronic application: Anticipated for August 2009. • Application Submission Dates: April 8, August 8, and December 8 • Two-level review: • Evaluation by Study Section (Peer Review). • Evaluation by Institute Program Staff. • Generally 5-6 month period from receipt to earliest possible award. • Check Program Announcements for variations.

9. NRSA Stipends: FY 2008

10. Tuition and Health Insurance: Policy *Help defray costs such as research supplies, equipment, Health Insurance, fellow’s travel to scientific meetings and appropriate administrative costs.

11. Fellowship Review Criteria • Candidate: Previous and current academic and research performance; Potential, and commitment to biomedical research career. • Sponsor/Mentor and Training Environment: Qualifications of mentor for proposed research training, and successful competition for research support; Quality of environment and institutional commitment to training; Availability of facilities/resources; and funding. • Research Training Proposal: Merit of the proposal; Quality of research training plan; Training as foundation for candidate’s productive career. • Training Potential: Value of the proposed fellowship experience as it relates to the candidate's needs in preparation for a career as an independent researcher. • Training in the Responsible Conduct of Research: Applicants are encouraged to creatively tailor a plan to meet own needs in relation to proposed research training.

12. Helpful Hints for Fellowships • Read the Program Announcement and Contact NIH staff. • Read the Instructions in the application kit. • Give yourself and your sponsor enough time. • Give references enough time. • Training should be appropriate considering previous experience. • Project should have merit as research and as training mechanism. • Capable and experienced sponsor? Co-sponsor? • Same training site? • Observe application limitations • Arrange for pre-review.

13. Research Career Development Awards Mentored Scientist Career (K01) Mentored Patient-Oriented Career (K23) Mentored Clinical Scientist Career (K08) Quantitative Career Award (K25) Pathway to Independence (K99/R00) • Principal Investigator • Team Scientist Undergraduate Grad or Med School Postdoc or Residency Independent Scientist (K02) Midcareer Patient-Oriented (K24) Senior Scientist Award (K05)

14. Common Features: Eligibility • Read Program Announcements carefully and contact NIH staff. • Research doctoral degree (K01, K02), but some require clinical doctoral degree (K08, K23). • US Citizens, Non-Citizen Nationals, Permanent Residents (except K99/R00). • Previous NIH Principal Investigators may be Ineligible • Usually Principal Investigator on R03 or R21 is OK (except K99/R00). • Principal Investigator on R01 or subproject Principal Investigators on a P01 is not OK.

15. Common Features: Duration • Three, Four, or Five years depending on mechanism and justification of need. • Extensions in time – award terms remain in effect (i.e. minimum effort, no salary from other federal funding source). • Entry level awards require a mentor, multiple mentors are encouraged. • Mentored K awardees are encouraged to apply for independent support during the K award.

16. Common Features: Effort • At least 75% effort committed to research and the rest on other career development activities. • Policy:Awardee must have a full-time appointment (12 person months) at applicant institution, and the minimum effort requirement must be covered by that appointment. • Policy Update:Mentored K awardees in final 2 years may reduce effort (to minimum of 50%) on K if replaced by effort as Principal Investigator on research project or subproject of Center grant, provided they remain in mentored situation. • Temporary reduction permissible in unusual and pressing circumstances.

17. Common Features: Costs • Vary across NIH Institutes and Centers, so read specific announcements carefully and contact NIH staff. • Salaries capped between $75,000 and legislated cap ($191,300 for FY 2008). • Fringe benefits are in addition to any cap, plus 8% F&A costs. • Salary supplementation OK, but must be from non-Federal sources and must not require extra duties that would interfere with K activities. • Research costs: Generally $25,000 to $50,000 and commonly used for supplies, equipment, technical personnel, travel to research meetings or training, tuition/fees, computational services. • Ancillary personnel support is not allowed, such as salary for administrative/secretarial support, support for mentors.

18. Common Features: Application • Use PHS Form 398: Career Award Section. • Transition to electronic application: Anticipated for February 2009. • Application Submission Dates: February 12, June 12, and October 12 • See also special instruction in a particular Funding Opportunity Announcement. • Institutes and Centers use of career awards is highly variable! So, read the announcement carefully and call the NIH staff! • In K announcements, see contact web-table in for participating Institutes and Centers.

19. Mentored Career Awards: Which One? • K01: Mentored Research Scientist Development Award. • K08: Mentored Clinical Scientist Development Award. • K23: Mentored Patient-Oriented Research Development Award. • K25: Mentored Quantitative Research Development Award. • K99/R00: NIH Pathway to Independence (PI) Award. • K02: Independent Scientist Award. • K24: Mid-Career Patient-Oriented Research Development Award. • K12: Institutional Mentored Research Scientist Development Program.

20. K01: Option for Research Doctorates • Provides an intensive, mentored research experience for a period of up to 5 years. • Minimum of 75% full-time professional effort is required (based on 12 person months appointment). • Candidates must have a research doctorate and postdoctoral experience. • Caution: Not an extension of postdoctoral training! • Varied and limited NIH Institute and Center (IC) participation: • Some ICs use for re-entry. • Some ICs use to pursue new research area. • Requires plan for independence.

21. K08: Option for Health Prof. Doctorates • Supervised research experience for individuals who are committed to a career in laboratory or field-based research. • Minimum of 75% full-time professional effort is required (based on 12 person months appointment). • Candidates must have a health professional doctorate, but may or may not have postdoctoral experience. • Potential for phased award periods: • Didactic experience. • “Hands-on” research experience. • Usually supports non-patient-oriented research.

22. K23: Option for Patient-oriented Research • Supervised study and research career development for clinically trained professionals with a commitment to patient-oriented research. • Minimum of 75% full-time professional effort is required (based on 12 person months appointment). • Candidates must have a health professional doctorate, but may or may not have postdoctoral experience. • Must have completed clinical training, (including specialty and sub-specialty if applicable) prior to award. • May submit application prior to completion of clinical training. • Patient-Oriented defined as research conducted with human subjects, or material of human origin such as tissues, specimens.

23. K25: Option for Quantitative Scientists • Mentored experiences for scientists from quantitative and engineering backgrounds interested in pursuing health-related research. • Minimum of 75% full-time professional effort is required (based on 12 person months appointment). • Candidates must have a research doctorate and ideally some postdoctoral experience. • Unique among NIH K awards in that eligibility spans the postdoctoral to senior faculty levels, although some Institutes have exceptions to this general rule.

24. K99/R00: Option for Career Transition • Provides up to 5 years of support in two distinct phases: Mentored and Non-Mentored. • K99 phase: Mentored research experience for up to 2 years. • R00 phase: Independent scientist phase for transition to independence as junior faculty (up to 3 years). • Applicants may have no more than 5 years of postdoctoral training at the time of initial application or any resubmissions. • K99 is unique among NIH K awards in that both U.S. citizens and non-U.S. citizens may apply. • Domestic institutions only (both phases). • Transition to R00 phase requires offer and acceptance of tenure-track, full-time assistant professor position, or equivalent.

25. K02: Option for Independent Researchers • For newly independent scientists who demonstrate a need for a period of intensive research focus in order to enhance their research careers. • Minimum of 75% full-time professional effort is required (based on 12 person months appointment) • Limited NIH Institute and Center participation, and some require NIH support. • May be renewable if continued support is justified. • Provides only salary and fringe benefit support, and thus requires other research support exists. • Salary is pro-rated up to legislated maximum rate.

26. K24: Option for Patient-Oriented Researchers • Provides clinician investigators protected time to devote to patient-oriented research & to serve as research mentors for junior patient-oriented researchers. • Protects between 25% and 50% of full-time professional effort (based on 12 person-months appointment). • Candidate must engage in patient-oriented research. • In addition, candidate must propose a plan to provide mentoring to more junior patient-oriented investigators. • Salary is pro-rated (up to legislated maximum rate). • Salary from other Federal sources OK for non-K effort • Nearly all Institutes and Centers participate.

27. Common “K” Review Criteria (1 of 3) • Candidate: • Potential to develop as an independent and productive researcher. • Quality of research, academic and/or clinical record. • Commitment to become an independent researcher. • Quality of the letters of reference. • Mentor(s) Statement. • Career Development Plan: • Likelihood that plan will contribute substantially to the scientific development of candidate leading to scientific independence. • Content, scope, phasing, and duration of the career development plan in the context of prior experience and stated training objectives. • Plans for monitoring and evaluating the candidate's research and career development progress.

28. Common “K” Review Criteria (2 of 3) • Research Plan: • Scientific and technical merit of the research question, design and methodology. • Relevance of the proposed research to the candidate's career objectives. • Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan. • Training in the Responsible Conduct of Research: • Quality and appropriateness of the proposed training in the responsible conduct of research.

29. Common “K” Review Criteria (3 of 3) • Statements by Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s): • Appropriateness of mentor's qualifications in proposed research; Extent of mentor's role in providing guidance to the candidate; Previous experience in fostering development of independent investigators. • History of research productivity and peer-reviewed support; Adequacy of active/pending research support. • Environment and Institutional Commitment to the Candidate: • Commitment of institution to ensure that a minimum of 75% of the candidate's effort will be devoted directly to research. • Adequacy of research facilities and training opportunities, including capable faculty. • Assurance that institution intends for the candidate to be an integral part of its research program.

30. Helpful Hints for “K” Applicants • Read the Program Announcement carefully and contact NIH Program staff. • Read the Instructions in the application kit. • Give yourself and your mentor(s) enough time. • Give your references enough time. • Training or career development plan should be appropriate considering previous experience. • Project should have merit as research and as training or career development vehicle. • Capable and experienced mentor/sponsor? Co-sponsor? • Arrange for pre-review.

31. NIH New Investigators Programs • Pathways to Independence Award (K99/R00): facilitate receiving an R01 award earlier in an investigator's research career. • NIH Director's New Innovator Award. • NRSA Individual and Institutional Training Awards. • Career Development Awards. • Research Project Grants. • Institute and Center Practices. • Resources for New Investigators. • NIH Loan Repayment Programs.

32. NIH New Investigator Policy • Goal is to encourage funding for scientists new to NIH and those who are at an early stage in their careers. • New investigators are considered essential to the vitality of health-related research, thus several NIH initiatives to nurture promising scientists. • New policy intended to level the playing field to allow new investigators to achieve success rates comparable to those of established scientists. • Early Stage Investigator (ESI): New or First-time investigator within 10 yrs of completing last research degree or within 10 yrs of completing medical residency. • The ESI policy is an important part of NIH initiative to enhance the peer review process with a goal to “fund the best science, by the best scientists, with the least amount of administrative burden.”

33. New Investigator Initiative • New Investigators receive special attention at Council as high program priority or equivalent. • Increased payline for scored R01 applications from New Investigators. • No imposed reductions in duration and amount of awards (beyond the recommendations of the initial review group) for New Investigators. • Fund applications to achieve a designated success rate rather than setting a specific payline for New Investigators applying for R01s. • R01 New Investigators whose applications score below the payline can submit 5-page letters responding to critiques in the summary statement for Advisory Council review. If these letters respond satisfactorily to the concerns raised by the study sections, the Council can decide to fund these applications, avoiding the need for resubmission. • http://grants1.nih.gov/grants/new_investigators/index.htm

34. New Innovator Award (DP2): Purpose • New Innovator awards are designed to support unusually creative new investigators with highly innovative research ideas at early stage of their career when they may lack preliminary data required for an R01 grant. • New Innovator award program complements ongoing efforts by NIH to fund new investigators through R01 grants. • Competition in FY09 will proceed in two phases: Pre-Application, evaluated by external reviewers, followed by Full Application. • Peer review emphasizes the potential of the project, if successful, to have a significant impact on an important biomedical or behavioral research problem.

35. New Innovator Award (DP2): Eligibility • Applicants must hold an independent research position at a domestic institution, and received doctoral degree or completed internship/residency within past 10 years. • Definition of “new investigator” – Not awarded an R01 or equivalent NIH grant. Current/past mentored K awardees eligible. • Must commit at least 25% of research effort each year to activities supported by the New Innovator Award. • There are no citizenship or residency requirements. • Awards will be for up to $300,000 in direct costs each year for five years, plus applicable F&A costs. Up to 24 awards will be made in 2009.

36. NIH Small Grant Program (R03) • Provides limited funding for a short period of time to support a variety of types of projects, including: • Pilot or feasibility studies; • Collection of preliminary data; • Secondary analysis of existing data; • Small, self-contained research projects; • Development of new technology, etc. • Limited to two years of funding. • Direct costs generally up to $50,000 per year. • Not renewable. • Utilized by more than half of the NIH Institutes and Centers. • See parent FOA at: http://grants2.nih.gov/grants/guide/pa-files/PA-06-180.html

37. Exploratory/Developmental Research (R21) • Encourages new, exploratory and developmental research projects by providing support for the early stages of project development. • Sometimes used for pilot and feasibility studies. • Preliminary data are not required but may be included if available. • Limited to up to two years of funding. • Combined budget for direct costs for the two year project period usually may not exceed $275,000. • No preliminary data is generally required. • Most Institutes and Centers utilize the R21 program. • See parent FOA at: http://grants2.nih.gov/grants/guide/pa-files/PA-06-181.html

38. Pioneer Award (DP1): Purpose • Pioneer Awards are designed to support individual scientists of exceptional creativity who propose pioneering – and possibly transforming approaches – to major challenges in biomedical and behavioral research. • The term “pioneering” is used to describe highly innovative approaches that have the potential to produce an unusually high impact on a broad area of biomedical or behavioral research. • The proposed research must reflect ideas substantially different from those already being pursued in the investigator’s laboratory or elsewhere.

39. Pioneer Award (DP1): Eligibility • Investigators at all career levels are eligible, and those at early to middle stages of their careers especially encouraged to apply. • Awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Pioneer Award. • There are no citizenship or residency requirements. • Awards will be for up to $500,000 in direct costs each year for five years. • It is anticipated that at least 5-10 awards will be made in 2009.

40. Transition to Electronic Applications E-Submission using the SF424 (R&R) http://era.nih.gov/ElectronicReceipt/ Career (“K”) Applications Fellowship (“F”) Applications Training (“T”) Applications 01 02 06 08 09 11 12 03 04 05 07 10 2009

41. Useful NIH Websites • NIH Institutes and Centers: http://www.nih.gov/icd/ • Grants and Funding Opportunities: http://grants1.nih.gov/grants/ • Research Training Opportunities: http://grants1.nih.gov/training/index.htm • Forms and Applications: http://grants1.nih.gov/grants/forms.htm • Electronic Submission of Applications: http://era.nih.gov/ElectronicReceipt/ • Grants Policy and Guidelines: http://grants1.nih.gov/grants/policy/policy.htm • NIH Guide for Grants and Contracts (the NIH Guide)http://www.nih.gov/grants/guide/index.html