Writing an Effective K Application

1. Writing an Effective K Application P. Kay Lund, PhD, kay.lund@nih.gov Henry Khachaturian, PhD, hk11b@nih.gov Division of Biomedical Research Workforce Office of the Director National Institutes of Health

2. NIH includes 27 Institutes and Centers National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of General Medical Sciences National Center for Complementary and Integrative Health National Institute on Minority Health and Health Disparities Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering Clinical Center Center for Information Technology Center for Scientific Review Office of the Director Office of Extramural Research Division of Biomed Research Workforce (DBRW) Office for Scientific Workforce Diversity Office Intramural Training and Education

3. FY 2017 Operating Budget: $33,187,696M Training: $841,246 Career: $688,702 Total: $1,529.948 NIH Budget Office: http://officeofbudget.od.nih.gov/index.htm

4. Postdoctoral and Early Research Career Training Postdoctoral Training/Clinical Residency Early Research Career Graduate/ Clinical Training Established Investigator K01, K07, K25 K08, K23 K22, R00 K22, K99 Loan Repayment Programs Diversity Supplements

5. NIH Research Training Website https://researchtraining.nih.gov • Launched in 2015, one stop for funding opportunities • Useful resource for trainees and early stage faculty • Modifications and integration with new DBRW website in progress

6. Career (K) Kioskhttps://researchtraining.nih.gov/programs/fellowships

7. Timeline for K Applications • Receipt Date: • Feb 12 (Mar 12) • Jun 12 (Jul 12) • Oct 12 (Nov 12) • Review: • Jun/July • Oct/Nov • Feb/Mar • Council: • October • January • May • Award Date: • December • April • July

8. Tips for Writing an Effective K Application • Start Early • Develop a Strategy • Plan Your Application • Application Requirement • Review Criteria

9. Clinical Trials in K Awards • Funding Opportunity Announcements (FOA) will eitherpermit PD/PI to conduct independent clinical trials or will not permit independent clinical trials but encourage, where relevant, clinical trials research experience under mentor guidance • Independent Clinical Trial: Led and funded by the PD/PI of the K application, may be an independent ancillary trial to a larger trial, may be a feasibility study. Will require completion of the human subjects/clinical trial form. • Clinical Trials Research Experience: K applicant will gain experience, participate in a clinical trial led by a mentor (responsible for funding and documentation) Learn more at https://grants.nih.gov/policy/clinical-trials/specific-funding-opportunities.htm

10. Start Early • Start at least 6 months prior to the application due date (or begin planning even sooner) • Get an NIH Commons account at least a month before the application deadline • Know your organization's AuthorizedOrganizational Representative (AOR) to assist with the application • Notify your referees early and give them plenty of time to submit letters of reference (ensure they have current CV and aims of grant)

11. Develop a Strategy (1 of 2) • Assess your career situation and needs. Is there added value to a K award? Why not another funding mechanism? • Check which NIH Institute or Center (IC) funds K awards in your research area • Schedule a phone call with anNIH Program Officer to discuss your research area, training needs and career development plans • Assess the field and the competition. See what is being funded by NIH: ResearchPortfolioOnlineReporting Tools (RePORT: https://report.nih.gov)

12. Develop a Strategy (2 of 2) • Identify mentor(s) and collaborators- discuss your plans, project and career development needs early to be sure they are on board • Consider your strengths and areas for growth? • Can you fill any gaps and gain essential experiences with proposed mentor, collaborators or consultants? • Identify essential resources and support needed and consider if this is available within your organization – or must be obtained elsewhere

13. Plan Your Application • Coordinate with your mentor(s) – a K application is a collaboration between you and your mentor(s) • Put together a review committee to assist planning and provide critical feedback • Draft a short description of your specific aims and discuss these with the committee – chalk talk, diagrams, central hypotheses, scope • Be sure the project is distinct from your mentor’s research and that the mentor is supportive of future independence

14. Don't Propose Too Much • Avoid an “over-ambitious” project – but it should be novel and significant! • Your hypothesis should be testable and aims doable with the resources you are requesting (and mentor support) • The scope of your hypothesis and aims should match available time and resources • Your research and career development objectives should be related/matched EXAMPLES New Research Directions Career Development • RNA Sequencing • Novel imaging approaches • Bioinformatics workshop & courses • Expert collaborator + core facility

15. Application Requirements • Candidate Qualifications, Career Goals and Objectives • Mentor(s), Collaborators, and Consultants • Institution’s Environment and Commitment to the Candidate • Specific Aims • Research Strategy

16. A Few Tips as You Write Make Life Easy for Reviewers: • Write clearly and concisely • Label all components clearly • Make sure figures and legends are readable • Avoid TMI – a figure is worth a thousand words! • Guide the reviewers with graphics as much as possible • Edit and proofread Know These Review Problems and Solutions: • Write a compelling argument for why your career will be advanced to independence and enhanced by receiving a K award • Write for both experts and non-experts in your field • Cite the work of experts as reading articles in the field

17. Candidate’s Qualifications Biographical Sketch: • Education/training • Contributions to science – background, findings, influence/impact, your specific role, cite publications or research products • Personal statement – your research experience and other qualifications for this K award • Research support – ongoing and completed research projects, accomplishments of you and your mentor(s)/colleague(s) attesting to qualifications of the research team

18. Candidate’s Background • Can coordinate with information in the biosketch, but make sure key information is provided here, even if it repeats biosketch • Commitment to an academic research career • Interactions, collaborations • Research achievements experience and potential • Other relevant experience (leadership, teaching, mentoring)

19. Career Goals and Objectives of the K Award • New or enhanced research skills you will gain • Other activities to enhance your research career, e.g., courses, workshops, techniques, teaching, mentoring (including ‘soft skills’ management, leadership) • If you have changed research direction, discuss the reasons and justify how it will help you to develop your research career • Provide a career development timeline, including plans to apply for subsequent grant support • Career development can include a visit to another laboratory, to learn new technologies or approaches (network for the future!)

20. Sponsor/Mentor(s), Collaborators, Consultants • Primary/Key Sponsor/Mentor(s)must explain how they will tangibly contribute to the development of the applicant • Discuss research and career development activities: • Regular interactions with applicant, how interactions and proposed activities advance applicant’s research and career • Document sources/amounts of anticipated support for the applicant’s research project • Mentor(s) should discuss the plans for transitioning the candidate to independence by the end of the K award- and convey clear support for the pathway to independence • Provide details of previous experience as a mentor and outcomes of mentees

21. Institutional Environment & Commitment • Document a strong, well-established research program related to the candidate's interests • Experienced faculty, facilities and resources • Opportunities for intellectual interactions, e.g., journal clubs, seminars, and presentations • Research Centers or Program Projects which may provide resources and interactions to promote your success • Commitment to the candidate’s career development independent of the K award • Adequate office and lab space, time and support to the candidate for the period of K award

22. Specific Aims of the Project • Test a central hypothesis & sub-hypotheses • Solve a specific problem & address a critical barrier to progress in the field • Challenge an existing paradigm or develop new technology • All members of the review panel may read this page • State the problem, why you can solve it, what’s new & the hypothesis and sub-hypotheses related to each aim • A summary figure helps! • End with why completing the aims will be a major contribution to the biomedical field or clinical practice and to your career development

23. A Few Tips on the Hypothesis • Strong, testable hypotheses rather than advance in technology or ‘collecting’ information • Aim 2 should still be doable/meaningful if aim 1 does not pan out • Ask questions that prove or disprove a hypothesis rather than use a method to search for a problem or simply collect information • Methods are the means to perform your experiments. Your experimental results and appropriate statistical analyses will prove or disprove your hypothesis • The hypothesis must be testable during the the K award and with the level of available resources

24. Research Strategy (1 of 3) Significance: • The importance of the problem you are trying to solve • How your study and anticipated results will improve scientific knowledge, technical capability, or clinical practice in one or more fields • How existing concepts, methods, technologies, treatments, or interventions may be impacted if the proposed aims are achieved

25. Research Strategy (2 of 3) Innovation: • How your proposed research will challenge or improve current research or clinical practice paradigms • Novel theoretical concepts, approaches, methodologies, or interventions that may be developed or used • Advantages over existing approaches, methodologies, instrumentation, or interventions

26. Research Strategy (3 of 3) Approach: • Methods and analyses to test the hypotheses and accomplish the specific aims (attention to positive and negative controls or randomization where appropriate). • Benchmarks for success anticipated to achieve the aims. • Potential problems and alternative strategies. • For early stages of development, describe strategies to establish feasibility and manage high-risk aspects of the proposed work. • Rigorous experimental design – power calculations, sufficient N, biological variables, appropriate statistical tests and authentication of reagents.

27. Career Award Review Criteria Scored Review Criteria: • Candidate • Career Development Plan, Goals and Objectives • Research Plan (Includes review of Scientific Premise, rigorous experimental design, biological variables) • Mentor(s), Consultants(s), Collaborator(s) • Environment and Institutional Commitment to the Candidate

28. Career Award Review Criteria (1 of 4) Candidate: • Research, academic and/or clinical record • Commitment and potential to develop as an independent and productive researcher • Quality of letters of reference (referees know you!) Career Development Plan, Goals and Objectives: • Contribute substantially to the scientific development of candidate • Content, scope, phasing, and duration of the plan in the context of prior experience

29. Career Award Review Criteria (2 of 4) Research Plan: • Scientific and technical merit of the research question, design and methodology • Strong premise, rigorous experimental design and statistical analyses, unbiased approach, addresses relevant biological variables • Relevance of the proposed research to the candidate‘s career objectives • Is the research plan appropriate to the stage of research development and developing the research skills described in the career development plan?

30. Career Award Review Criteria (3 of 4) Mentor(s), Consultants(s), Collaborator(s): • Qualifications, funding, and statement by Mentor(s), collaborators, and/or Consultants • Clear commitment and plan for career development and pathway to independence • Mentors and collaborators must have real roles – i.e. be clearly involved and have the time to commit Environment and Institutional Commitment to the Candidate: • Assurance that minimum 75% effort will be devoted to research and related activities • Capable faculty and research facilities • Assurance that the candidate is considered an integral part of the institutional research program

31. Career Award Review Criteria (4 of 4) Additional Review Criteria: • Protection of Human Subjects • Inclusion of Women, Minorities, and Children • Care and Use of Vertebrate Animals • Biohazards Additional Review Considerations: • Responsible Conduct of Research • Select Agents • Authentication of key biological or chemical resources • Resource Sharing Plans • Budget and Period of Support

32. Rigor in K Award Application and Review

33. About Grants http://grants.nih.gov/grants/about_grants.htm Receipt & Referral Grants Basics Peer Review Grants Process Overview Plan Your Application Pre-Award Process How to Apply Post-Award Monitoring and Reporting

34. Keep the Joy in Research Writing a Grant is Fun Trainees and Mentees Provide a Scientific Family Forever THANK YOU ! QUESTIONS ?

35. Research Career Development Awards (K-Awards – Goals & Types) • Goal: Develop a diverse pool of highly trained scientists, in appropriate scientific disciplines, to address the Nation's biomedical, behavioral, and clinical research needs • Institutional Career Development Programs: • Awards to an institution to support career development activities for appointees (scholars) selected by the institution • Requires a program director and experienced faculty to serve as mentors • Individual Career Development Programs: • Applicants must identify a mentor at a domestic (U.S.) institution • Mentor must be well-funded and have significant experience and commitment to advancing the career of the scholar • Significant institutional commitment is critical to success of application

36. K-Awardees or Appointees • Must be citizens, non-citizen nationals, or lawfully admitted for permanent residence in the U.S. at the time of award/appointment • Must have a research or clinical doctoral degree from an accredited domestic (U.S.) or foreign institution • Must have a full-time appointment at the institution, and commit a minimum of 9 person-months (75% of full-time professional effort) to research career development • Cannot be former PD/PIs on major NIH research grants (e.g. R01 equivalent), or other individual career development (K) awards. • Appointees to institutional K12/KL2 awardees are eligible to apply for individual K K-Kiosk: https://researchtraining.nih.gov/programs/career-development

37. Individual Mentored K Awards • Support protected time for intensive, mentored career development experience : expectation for transition to an independent Research Intensive position • K01 Research Scientist: Biomedical or behavioral sciences • K08 Clinical Scientist:Individuals with clinical doctoral degrees pursuing translational research—application of basic research discoveries toward the diagnosis, management, and prevention of human disease • K23 Patient Oriented: Investigators committed to Patient-Oriented Research (POR – direct interaction with human subjects; research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies) • K22 Transition:Facilitates transition from the mentored stage to the independent stage, typically transition from postdoctoral training to independent (e.g., assistant professor) position • K99/R00 Pathway to Independence: Facilitates rapid transition from a mentored postdoctoral position to independent research position (No more than 4 years from doctorate or residency at the time of application)

38. Brief Overview of Grant Process Brief Overview of Grant Process Department of Health and Human Services Part 1. Overview Information National Institutes of Health (NIH) Funding Opportunity Title NIH Pathway to Independence Award (Parent K99/R00) PA-16-193 FOA Program Staff Application Feedback & Revision NIH Award CSR Institute/Center Study Section and Council Review

39. Responsible Conduct of Research • Discuss the five components outlined in the NIH Policy: • (1) Format, (1) Subject Matter, (3) Faculty Participation, (4) Duration, and (5) Frequency • Is the plan appropriate for your career stage, and will it enhance your understanding of ethical issues related to research? • Document any prior participation in RCR training and/or propose plans to receive additional instruction

40. Diversity Supplement Administrative supplement to an existing, actively funded research grant Designed to: • Support candidates from underrepresented groups who “wish to develop research capabilities…participate in…career development experiences” • Support many career stages from undergraduate to faculty • Could be a bridge to a K for postdoctoral researchers or early stage faculty • Add to ongoing research and career development • Expectation of a subsequent application for NIH support • Diversity workforce PA-16-288:https://grants.nih.gov/grants/guide/pa-files/PA-16-288.html • Administratively reviewed by the Institute or Center (IC) funding the original grant • Note: different ICs have different deadlines and policies