Writing NIH Career Development (K) Awards

1. Writing NIH Career Development (K) Awards Overview Breaking Down the K Award Task List Additional Resources Ardis Hanson PhD College of Behavioral and Community Sciences 2013

2. What is a K Award • Career Development Awards (K awards) are one of the most successful NIH programs. • Over the past 5 years, K award funding has steadily increased NIH-wide, and in 2011, overall K award success rates were 35% across all institutes. • 3 – 5 years in length • Provide substantial salary support but limited research funding. • Contains both a training plan and a research plan. • Includes a team of mentors, co-mentors, advisors, etc. • Goal: Transition to research “independence”.

3. Mentored K awards • Intent is to help promising new investigators achieve research independence and compete successfully for R01 funding. • The K award is the preparation for the R01 grant application you will submit at the end of the K award. • If you already have substantial formal training in research, emphasize the importance of ‘hands-on’ research experience. • Reviewers expect you to fully exploit the training resources available to you.

4. Mentored K awards (continued) • Craft a compelling argument why you need a K award • Explain exactly how additional training and mentored research experience will enable you to compete successfully for R01 funding. • Be specific: give concrete examples of areas where • you need additional training or experience in order to conduct the proposed research or • areas where you are deficient that are directly related to your research career goals.

5. Mentored K awards (continued) • The career development training plan should be uniquely suited to you. • Propose a mix of didactic training and “hands- on” research experience that make perfect sense for you (and only you) based on your previous training and research experience, and your short- and long-term career goals • If you are considering degree-granting programs to acquire formal training in research, remember to customize the program whenever possible.

6. Review Criteria • Quality of the candidate’s academic and clinical record. • Potential to develop as an outstanding independent researcher. • Likelihood that the career development plan will contribute substantially to the scientific development of the candidate. • Appropriateness of the content and duration of the proposed didactic and research phases of the award. • Consistency of the career development plan with the candidate’s career goals and prior research experience.

7. Breaking Down the K Award The Candidate Section Statements by Mentors, Co-Mentors, and Collaborators Environment and Institutional Commitment Research Plan Human Subjects Budgets Biosketch Abstract & Project Narrative Cover Letter and Letters of Reference

8. 4 Main Sections • The Candidate (Sections 2 – 5) • Statements by Mentors, Co-Mentors, and Collaborators (Section 7; limited to 6 pages) • Description of Institutional Environment (Section 8; limited to 1 page) • Institutional Commitment to Candidate’s Research Career Development (Section 9: limited to 1 page) • Research Plan (Sections 10 and 11)

9. The Candidate Section

10. The Candidate • Section 2: Candidate’s background • Section 3: Career goals and objectives • Section 4: Career development activities during award period • Section 5: Training in the responsible conduct of research • Be brief and concise • Sections 2 -5 + the Research Strategy (Section 11) combined cannot exceed 12 pages.

11. 2. Candidate’s Background • Suggested length: Less than 1 page. • Use your NIH biosketch as a guide for the personal narrative of your professional career. • Explain why you made key career choices, such as training opportunities or research projects). • OK to use 1st person. • Examples of the opportunities you’ve had to engage in research (basic or clinical) shows evidence of your long-standing commitment to research. • Highlight early evidence of productivity (e.g., pursuing a specific question, analyzing data, presenting or publishing your results). • Describe any formal research training (e.g., TICR, MPH).

12. How to Start • Begin this section with a summary statement regarding your long-term research career goals. • Example: NEED GOOD EXAMPLE

13. Section 3: Career Goals and Objectives • Suggested length: 1 - 2 paragraphs • Your proposed research plan should include specific ‘challenges’ that requires additional training and/or experience for you to accomplish successfully. • These challenges (deficits) in your training/experience then become the focus of your career development training plan. • Example: NEED GOOD EXAMPLE

14. Section 4: Career Development Activities During Award Period • Suggested length: 1 - 2 pages. • List the specific training areas you will pursue to acquire the set of skills you need. • Explain why additional training and mentored research experience in these areas are critical to accomplish your short-term and long-term career development • Describe in detailhow you will gain this training • specific courses, individualized tutorials, or practical experience from conducting the research • Example: NEED GOOD EXAMPLE

15. Section 5: Training in the Responsible Conduct of Research • Format: To ensure general proficiency, I will take the following Courses [titles] designed to address the requirements of NIH for education of investigators about ethical issues in human subject research. • Subject matter: I will have an understanding of the regulations that govern human subjects research, as well as training modules of the Health Insurance Portability and Accountability Act as it applies to research. In additional modules I will learn how to identify and resolve common ethical dilemmas that arise in clinical research, how research on human subjects is regulated by the federal government, and what constitutes research misconduct. • Faculty participation: • Duration of instruction: • Frequency of instruction: I will receive my most intensive instruction in responsible conduct of research during the first two years of this proposal. However, I will continue to receive guidance from my mentors and scientific advisors throughout all five years of this proposal.

16. Statements by Mentors, Co-Mentors, and Collaborators

17. Assembling a Team • Establish a relatively small (3-4) mentoring committee. • Each member of your “team” must play a role in your training or research plan. • Primary mentor should be a USF senior investigator with a track-record of NIH funding • Co-mentors should complement the primary mentor’s strengths and be located within the Tampa Bay area. • If you need to add additional members, call them scientific or technical advisors/collaborators with a relatively narrow focal area and area of responsibility.

18. Considerations • This section is limited to 6 pages. • Each member of your team must submit a signed letter. • The primary mentor’s letter should be at least 2 pages. • The rest of the team has only 4 pages. • Make sure that the letters are consistent with the text in the grant application • Frequency of meetings • Evaluation measures/benchmarks • Resources and tools

19. Letters of Collaboration • Should also address the candidate’s • Potential for conducting original research • Evidence of originality • Adequacy of research background • Quality of research endeavors/publications to date • Commitment to research • Need for further research experience and training

20. Primary Mentor Letter • Appropriateness of mentor’s research qualifications. • Quality and extent of mentor’s role. • Previous experience in fostering junior researchers. • History of productivity and support. • Adequacy of support for the research project • Should also re-frame any potential weaknesses in the application. • Candidate productivity (few publications). • Feasibility of conducting research plan with K award monies. • Primary mentor’s limited mentoring experience. • Limited resources of primary mentor.

21. Letters of Collaboration • Letters from co-mentors et al. can be much shorter. • Include description of their role as co-mentor etc. • Describe qualifications specific to the proposed research area. • Include previous experience as a research supervisor and the nature and extent of supervision they will provide. • Describe how they will evaluate your progress. • Include specific benchmarks (e.g., manuscripts submitted). • Include specific resources that will support you during your training and/or research with them.

22. Environment and Institutional Commitment

23. Description of Institutional Environment • Evaluation criteria • Adequacy of research facilities • Availability of appropriate educational opportunities. • Quality and relevance of the environment for scientific and professional development of the candidate. • This section is limited to 1 page.

24. Institutional Commitment • Evaluation criteria • Scientific development of the candidate • Candidate will be “an integral part of its research program.” • At least 75% of the candidate’s effort for proposed career development activities. • These assurances are stated in a letter from your department chair or dean. • This section is limited to 1 page.

25. Letters of Recommendation • 3 - 5 letters are required from any period in your career. • Cannot be from your primary mentor or co-mentors. • From senior investigators with history of NIH funding and training of junior investigators. • Should address the candidate’s potential for a research career. • Potential for conducting research • Evidence of originality • Adequacy of scientific background • Quality of research endeavors or publications to date • Commitment to research • Need for further research experience and training

26. Research Plan: Specific Aims

27. The research plan is • A training vehicle which should be well integrated with your career development training plan. • A means to achieve independence (goal is an R01). • Modest in scope, feasible, and appropriate. • Think modular: secondary analyses of existing data, leverage ongoing studies, or conduct a small pilot study. • Address a clearly defined problem where each specific aim contributes to addressing that problem. • These applications are easier to write and easier to understand • Minimize your vulnerability in review • Maximize your ability to successfully conduct your proposed research.

28. Evaluation Criteria • Does your topic fit the mission of the NIH and match a funding priority of your NIH institute? • Is your research grounded in cure, prevention, or intervention? • What impact will your research have on public health?

29. Effective Strategies • Build a team • Seek opportunities for collaboration and identify collaborators to fill gaps in your expertise. • Consider multidisciplinary approaches. • Recruit senior colleagues who can provide advice and periodic peer-review of your grant application • Develop a good idea • Concentrate on ideas that impact practice and/or research. • Conduct a thorough, and systematic, review of the existing literature. • Pose interesting, important, and testable hypotheses.

30. Effective Strategies (continued) • Focus on grant writing fundamentals • Address a clearly defined problem. • Extend NIH knowledge by proposing interesting, important, and testable hypotheses that build on previous research. • Propose a scope of work that is appropriate to the track record of the principal investigator. • Don’t procrastinate • Get started at least 4-6 months before the application is due. • Arrange a dedicated time each week for grant-writing. • Build in time for a good and thorough peer review before you submit. • ‘Good enough’ is not good enough.

31. Specific Aims • Length: 1 page • Style: Non-technical. Write this section for the naïve reader. All study section members will all read it. • This section must include everything that is important and exciting about your project. • Keep it linear and upper level. Don’t get bogged down in details. • This section, together with the Significance and Innovation subsections, are the most important parts of the application to receive an affirmative vote of the majority of reviewers.

32. Specific Aims: Introductory Paragraphs • Start with an sentence that captures the reader, immediately establishes the relevance of your proposal, and starts a compelling argument for funding. • Describe the scope of the problem (e.g., number of people affected, morbidity/mortality, costs to society). • Describe the gap in knowledge that your project will address (builds the project rationale) • Reflect your “niche” area of research expertise. • State your long-term goal: Relevance to public health and its part of a larger research plan (to get an R01).

33. Specific Aims: Introductory Paragraphs (continued) • State the objective of this application • Each aim should consist of one concrete and concise sentence. • Emphasize “product” over “process.” • Keep the number of aims to a minimum (2-4). • Aims should be able to “stand alone”; related but independent. • Include rationales, when needed. • Link this to your long-term goal (i.e., next logical step along a continuum of research). • End with a rationale that tells reviewers why the expected outcomes from your study will clearly advance the field.

34. Research Plan: Research Strategy SECTIONS Specific Aims Research Strategy Significance Innovation Approach

35. Definitions • Length: 1 page, inclusive of both sub-sections • Style: Non-technical. • Justification for the need to research this area. • Significance: The positive effect that successful completion of your research project is likely to have by solving an important, NIH-relevant problem. • Innovation: A new and substantially different way of addressing an important, NIH-relevant problem, which enables departure from the status quo.

36. Significance • Increases the level of detail that will extend and validate what was written in the Specific Aims section. • Provide a critical analysis of the primary literature that describes the existence of a critical gap in knowledge. • Use some of the material from the “Background” section to substantiate and validates this as an important problem. • Explain why this problem must be resolved. • Describe the contribution you expect to make. [EXAMPLE] • Write a simple, direct statement why the expected contribution is important. [EXAMPLE] • Describe the positive impact your contribution will have (e.g., new ways of conducting research, decreased mortality/morbidity, QoL or Tx outcomes, reduction in cost of medical care, etc.)

37. Innovation • Emphasis on a new and substantially different way of addressing a critical NIH-relevant problem • Provide the context (with citations from the literature) so reviewers can understand how your project is innovative. • Again, borrow from the Background section with discussion of previous approaches and why they were unsatisfactory. [EXAMPLE] • “The proposed research is innovative because…..” states what objectively sets your project apart (approach or technology) compared to past investigators. [EXAMPLE] • Describe the positive impact that will result from your innovative approach that ties it as a concrete benefit to the NIH mission. [EXAMPLE]

38. Approach • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. • Discuss potential problems, alternative approaches, and benchmarks for success anticipated to achieve the aims. • If the project is in the early stages of development, describe strategy(ies) to establish feasibility and address management of any high-risk aspects of the proposed work. • If this is a new application, include information on Preliminary Studies as part of this section.

39. Organising this Section

40. Human Subjects

41. Human Subjects Research • A part of the peer review process will include careful consideration of protections from research risks for study participants, as well as the appropriate inclusion of women, minorities, and children. [Example] • The Study Section assesses the adequacy of the safeguards of the rights and welfare of research participants and the appropriate inclusion of women, minorities, and children. • Evaluation of the inclusion plans arefactored into the overall score for scientific and technical merit.

42. Budget

43. Budgets • Mentored K awards provide salary support for the candidate (@ $75,000/year) plus $25,000 to $50,000/year to cover the costs of the proposed training and research. • Amount of salary support and funds for research/training differ by institute. • A detailed, itemized budget is not required by NIH but it is required by USF. • You are required to provide to NIH a detailed description and justification for specific items in the budget. [Example]

44. Biosketch

45. Biosketches • This section must include the biographical sketches of all Key Personnel and Other Significant Contributors. • All biosketches must include a “Personal Statement” [EXAMPLE] • The section on publications should be limited to 15 (include only the most relevant, recent, and important). • For the candidate only, the section on Publications must be divided into the following categories: • Original research • Non-experimental articles (e.g., literature reviews, book chapters) • Books, pamphlets, etc.

46. Facilities and Other Resources

47. Facilities and Other Resources • Describe the Facilities and Other Resources used to conduct the research. [EXAMPLE] • Describe capacities, pertinent capabilities, relative proximity, and extent of availability to the project. [EXAMPLE]

48. Abstract & Project Narrative

49. Abstract & Project Narrative • Abstract • Limited to 30 lines of text (size 11 font, .5” margins). • Describes both the career development plan and the research plan. [EXAMPLE] • Project Narrative • Only 2 or 3 sentences long. • Explain the relevance of the proposed research to public health. • Plain language, think naïve reader. [EXAMPLE]

50. Cover Letter & Letters of Reference