1. NIH Career Development Programs and Early-Stage Investigators NIH Career Development Programs and Early-Stage Investigators Henry Khachaturian, Ph.D. NIH Extramural Program Policy Officer Director of Policy, NIH Loan Repayment Programs Office of Extramural Research, NIH Email: hk11b@nih.govhk11b@nih.gov 1 NIH Office of Extramural Research EB2013/FASEB – April 2013

2. National Institutes of Health Our mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.  World’s largest source of funding for biomedical research  Support more than 300,000 research personnel at over 3,000 universities and research institutions  27 Institutes and Centers (ICs) with specific research agendas

3. $767,132 Training $626,778 Career $1,393,910 $767,132 Training $626,778 Career $1,393,910 NIH Budget Office: http://officeofbudget.od.nih.gov/index.htmhttp://officeofbudget.od.nih.gov/index.htm 3 FY 2015 President’s Budget: $30,361,653

4.  NRSA Individual and Institutional Training Awards  Career Development Awards  Pathways to Independence Award (K99/R00)  Career Award Review Criteria  New and Early-Stage Investigators  NIH Loan Repayment Programs 4 NIH New Investigators Programs

5. Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training (T32) Postdoctoral Individual NRSA (F32) Small Grant (R03) Research Project Grant (R01) Independent Scientist Award (K02) Independent Scientist Award (K02) Senior Scientist Award (K05 ) Senior Scientist Award (K05 ) Career Stage ‘Formal’ Training/Career Awards GRADUATE/MEDICALSTUDENT POSTDOCTORAL EARLY MIDDLE SENIOR CAREER Predoctoral Institutional Training Grant (T32) Predoctoral Institutional Training Grant (T32) NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) Midcareer Investigator Award in Patient-Oriented Research (K24) Patient-Oriented Research (K24) Exploratory/Develop -ment Grant (R21) Pre-Bac Pre-Bac Institutional Training Grant (T34) Pre-Bac Institutional Training Grant (T34) Training & Career Development Support 2014 5 ‘Informal’ Training and Career Development on RPGs and Supplements Research Awards $767M $627M

6. Advice for Mapping Your Career With NIH  Review Institute/Center (IC) priorities and goals. Each IC has a research training and career development program.  Learn the NIH application and review process  Identify the grant programs offered by each IC  Make early contact with program officers  Find innovative, well-respected mentors and collaborators  Study successful grant applications- talk to your mentor  Propose your best and most creative ideas

9.  Authorized by Sections 301 and 405 of PHS Act.  42 U.S.C. 241 and 284; Regulations at 45 CFR 74 & 92  K-Awards provide “protected time” to engage in research and enhance research capabilities.  Early, mid, & senior level awards.  Majority require 75% of full time research effort.  Applicants must hold a research or health professional doctoral degree.  U.S. citizenship or permanent residency required.  2 types of awards:  Individual, e.g. K01, K02, K08, K18, K22, K23, K24, K25, K99/R00  Institutional, e.g. K12, CTSA (KL2) Research Career Development Authority 9

10.  U.S. Citizens, Non-Citizen Nationals, Permanent Residents (except K99/R00).  Research doctoral degree (K01, K02), but some require clinical doctoral degree (K08, K23, K24).  Must devote a minimum of 75% effort to research and career development activities. There are exceptions.  Previous NIH Principal Investigators may be Ineligible.  Principal Investigators on R03 or R21 are eligible to apply (except K99/R00).  Principal Investigators on R01 or subproject Principal Investigators on a P01 are not eligible to apply. 10 Career Development Award Eligibility

11. Individual Mentored:  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 Institutional Mentored:  K12: Institutional Mentored Research Scientist Development Program Individual Non-Mentored (Independent):  K02: Independent Scientist Research Development Award  K24: Mid-Career Patient-Oriented Research Development Award 11 Selected Career Development Awards

12.  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 participation:  Some ICs use for Re-Entry  Some ICs use to pursue new research area  Requires plan for independence. 12 Mentored Research Scientist Career (K01)

13.  Supervised research experience for individuals with health professional degree who are committed to a career in laboratory research.  Phased award periods: didactic experience followed by hands-on research experience.  Provides up to five years of salary and Research support and protected time.  Must demonstrate need for a period of intensive research focus to enhance career.  Must commit a minimum of 9 person-months (75% of full- time professional effort) to award. 13 Mentored Clinical Scientist Career (K08)

14.  Supervised research for clinically trained professionals with a commitment to focus on patient-oriented research (POR).  Must have completed clinical training, including specialty/sub-specialty, if applicable, prior to award.  Provides up to five years of salary and Research support and protected time.  Must demonstrate need for a period of intensive research focus to enhance career.  Must commit a minimum of 9 person-months (75% of full- time professional effort) to award. 14 Mentored Patient-Oriented Research (K23)

15.  Patient-Oriented Research (POR) is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes:  Mechanisms of human disease;  Therapeutic interventions;  Clinical trials, and;  The development of new technologies. 15 Qualifying Research for K23

16.  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. 16 Mentored Quantitative Scientist (K25)

17.  K99: Mentored research experience for up to 2 years.  R00: Transition to research independence as junior faculty for up to 3 years.  Applicants: no more than 5 years of postdoctoral research training at the time of initial application or resubmission.  Non-U.S. citizens may apply, but institution must be domestic.  Transition to R00 phase requires offer and acceptance of tenure-track, full-time assistant professor position (or equivalent). 17 Pathway to Independence Award (K99/R00)

18.  Institutional Mentored Research Scientist Development Program—Award is made to the institution.  Enhance research career development for individuals, selected by the institution, who are training for careers in specified research areas.  Provides institutions with a greater capacity and flexibility for mentoring junior investigators.  All other provisions of individual K awards apply to the award recipient.  Not transferable to another institution.  Usually solicited by a Funding Opportunity Announcement. 18 Institutional Career Development Program (K12)

19.  Foster development of outstanding scientists who can make significant contributions to their field of research.  Provides up to five years of salary support and “protected time” for newly independent scientists.  Must demonstrate need for a period of intensive research focus to enhance career.  Must have independent peer-reviewed research support at the time of award.  Must commit a minimum of 9 person-months (75% of full- time professional effort) to award. 19 Independent Scientist Award (K02)

20.  Attract and retain talented individuals to the challenges of patient-oriented research (POR).  Provides up to five years of salary support and “protected time” for mid-career scientists.  Enable mid-career clinician scientists to devote more time to POR, and sever as mentors to new clinical investigators.  Provides protected time to investigators who have their own independent peer-reviewed research support.  Must commit between 3 and 6 person-months (25% to 50% of full-time professional effort) to award. 20 Midcareer Investigator Award in POR (K24)

21.  Use SF 424 – Part I, Section 7: Supplemental Instructions for Preparing an Individual Research Career Development Award (CDA) Application. February 12, June 12, October 12.  Submission dates for new applications: February 12, June 12, October 12. March 12, July 12, November 12.  For resubmissions: March 12, July 12, November 12.  Institutes and Centers use of career awards is highly variable. Read announcement and instructions carefully and call the NIH staff!  In K announcements, see contact Webtable for participating Institutes and Centers. 21 Career Award Application and Due Dates

22. Mentored K Awards Independent K Awards Number of individuals appointed to institutional career award positions is an estimate. Number of Positions Individual & Institutional Positions on Ks: FY 2014 22

23. Success Rate of K01 Awards 23

24. Success Rate of K08 Awards 24

25. One Award Only Success Rate of K23 Awards 25

26. Success Rate of K99 Awards 26

27. My Application xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxx $$$ Center for Scientific Review Assigns IRG in CSR or IC Scientific Review Group Evaluates Scientific Merit Institute or Center (IC) Evaluates Relevance Advisory Council Recommends Action IC Director Allocates Funds PI / Institution Submits application Conduct Research Revision / Resubmission The NIH Review Process

28. Candidate:  Potential to develop as an independent and productive researcher.  Candidate’s academic, clinical (if relevant), and research record.  Evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator.  Letters of reference from well-established scientists: Evidence that the candidate has a high potential for becoming an independent investigator. Career Award Review Criteria (1 of 5)

29. Career Development Plan/Career Goals & Objectives:  Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence.  Appropriateness of contents, scope, phasing, and duration of the career development plan in the context of prior training/research experience and the stated training and research objectives for achieving research independence.  Adequacy of plans for monitoring and evaluating the candidate’s research and career development progress. Career Award Review Criteria (2 of 5)

30. Research Plan:  Significant and scientific/technical merit of the proposed research question, design, and methodology.  Relevance of the research plan to the candidate’s research 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. Career Award Review Criteria (3 of 5)

31. Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s):  Qualifications of the mentor(s) in the area of the proposed research, and previous experience in fostering the development of independent investigators.  Mentor(s) Statement: Candidate’s potential and his/her strengths and areas needing improvement.  Quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate.  Mentor’s description of the elements of the research career development activities, including formal course work adequate.  Mentor’s research productivity and peer-reviewed support. Career Award Review Criteria (4 of 5)

32. Environment and Institutional Commitment to the Candidate:  Adequacy and appropriateness of research facilities and resources including faculty capable of productive collaboration with the candidate.  High quality, research-intensive environment for scientific and professional development of the candidate.  Strength of the sponsoring institution’s commitment to the candidate including devoting a minimum of 9 person- months (75% of full-time professional effort) to research and career development activities.  Assurance that the institution intends the candidate to be an integral part of its research program. Career Award Review Criteria (5 of 5)

33. Resources:  NIH Extramural Training Mechanisms: http://grants1.nih.gov/training/extramural.htm http://grants1.nih.gov/training/extramural.htm  Ruth L. Kirschstein National Research Service Award (NRSA): http://grants1.nih.gov/training/nrsa.htm http://grants1.nih.gov/training/nrsa.htm  NIH Career Development Awards: http://grants1.nih.gov/training/careerdevelopmentawards.htm http://grants1.nih.gov/training/careerdevelopmentawards.htm 33 NIH Office of Extramural Research

34. Small Grant Program (R03) Overview:  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. Program Features:  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  Institute and Center contacts and policies: See Funding Opportunity Announcement

35. Exploratory/Developmental Research (R21) Overview:  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. Program Features:  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  Institute and Center contacts and policies: See Funding Opportunity Announcement

36. Academic Research Enhancement Award (R15) Overview:  Supports small-scale research projects in the biomedical and behavioral sciences conducted by faculty and students at educational institutions that have not been major recipients of NIH research grant funds. Goals of the Program:  Support meritorious research  Expose students to research  Strengthen the research environment of the institution Program Features:  Project period is limited to 3 years.  Direct costs are limited to $300,000 over the entire project period.  Grants are renewable.  Preliminary data are not required.  Institute and Center contacts and policies: See Funding Opportunity Announcement  R151@mail.nih.gov R151@mail.nih.gov 36

37. New and Early-Stage Investigators Concerns have been raised for decades about scientists spending long periods of time as postdoctoral appointees, unable to set their own direction Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research (2005) Becoming an independent research is taking longer and longer Age at First R01 Equivalent Award from NIH: FY 1980-2009

38. Revised New and Early Stage Investigator Policies (NOT-OD-09- 013) NIH is finding new methods to encourage funding (and hiring) of early-stage investigators Goal of funding new investigators at same rate as established investigators submitting new projects Support outstanding early- stage Investigators as they pursue high risk/high reward research New and Early-Stage Investigators A new program to allow exceptional young investigators to “skip” the post-doc!

39. Definition of New Investigator  A PD/PI who has not previously competed successfully for a significant NIH independent research award, other than the following awards:  Research Project Grants: R00, R03, R15, R21, R25, R90, (RL9, RL5), R34, R36, (R41, R43), R55, R56, SC2, SC3  All training Grants: T32, T34, T35, T90, D43  All Fellowships: F awards  Mentored Career Awards: All individual and institutional mentored K awards  Loan repayment contracts: L30, L32, L40, L50, L60  Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting Awards: G07, G08, G11, G13, G20, R13, S10, S15, S21, S22

40. Definition of Early Stage Investigator  A PD/PI who qualifies as a New Investigator is considered an Early Stage Investigator if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).  Implementing the Early Stage Investigator Policy: eRA Commons profiles include degree and residency completion dates  Encouraging early transition to research independence: Modifying the NIH New Investigator policy to identify Early Stage Investigators  Can request an extension of the Early Stage Investigator Period

41.  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. New Investigator Initiatives

42.  Support creative new investigators with highly innovative research ideas at early career stages.  No preliminary data required.  Evaluate pre-application—Invite full application.  Potential for significant impact on an important biomedical or behavioral research problem.  Applicants must hold independent research position at a domestic institution.  Doctoral degree or completed internship/residency within past 10 years.  Must commit at least 25% of research effort.  There are no citizenship or residency requirements. NIH Director’s New Innovator Award

43. Inspired in some respects by programs at Carnegie, Whitehead, UCSF, and other institutions showing that exceptional individuals do not require a post- doc to undertake pioneering research. Solicited and incorporated input from research community. First year will be a pilot (~10 awards) to test ideas and process, but may be scaled up in subsequent years. A new program to allow exceptional young investigators to “skip” the post-doc! “For the most creative of young scientists, nothing can equal the chance to have a lab of one's own.” Francis Collins, Nature, 2010 NIH Director’s Early Independence Award Program Features:  An institution may submit up to two applications  Awards will be up to $250K per year (direct costs) for up to 5 years

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

45. Extramural Loan Repayment Programs  Clinical Research  Pediatric Research  Health Disparities Research  Contraception and Infertility Research  Clinical Research for Individuals from Disadvantaged Backgrounds

46.  In exchange for a two-year research commitment, NIH repays qualified educational debt up to $35,000 per year. Payments made to lenders.  Research must be funded by a domestic nonprofit, university or U.S. federal, state or local government entity.  Recipients conduct research for an average of at least 20 hours per week over a quarter.  Tax liability on the loan payments is partially offset.  Apply September 1 – November 15.  1,600 researchers funded each year. Success rate is 40 percent for new applicants and 70 percent for renewals.  Additional Information: http://www.lrp.nih.gov/http://www.lrp.nih.gov/ Extramural Loan Repayment Programs