1. NIH Mentored Career Development Awards (K Series) Part 4 Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco

2. Research Plan A.Specific Aims B.Background and Significance C.Preliminary Studies D.Research Design and Methods

3. C. Preliminary Studies This section may consist of your own publications, publications of others (on your team), as well as unpublished data of yours or others. When using results from others, make sure it is clear which data are yours and which emanated from others. Length: + 6 pages.

4. Preliminary Studies (cont’d) Style: This section can be more detailed and technical than the Specific Aims and Background & Significance sections. However, it may be read by all reviewers, so technical jargon and acronyms should be avoided. Function: Demonstrates technical competence of research team (i.e., you have the expertise and competence to accomplish the specific aims you have proposed).

5. Preliminary Studies (cont’d) By providing preliminary data, this extremely important section helps build confidence that you can handle the technologies understand the methods interpret the results and, thus, achieve the aims you propose.

6. Preliminary Studies (cont’d) Interpret preliminary results critically. Give alternative meanings to the data to show you’ve thought the problem through and will be able to meet future challenges. If you don’t do this, the reviewers will! Tell them how your early work is relevant to and prepares you for the new project. See Examples 1, 2, and 3.

7. D. Research Design and Methods Length: +10 pages ( or approximately one-half the length of the research plan ). Organization and common subsections See Examples 4 and 4a. Overview of study design Describe the experimental design and procedures in detail and give a rationale for their use, if needed.

8. Research Design and Methods (cont’d) In many instances, you may have struggled with a crucial design question and arrived at a satisfactory solution. Don’t just present your solution. The reviewers may wonder why you chose a particular route. Therefore, you should provide a rationale for your decision and discuss the rejected alternatives.

9. Research Design and Methods (cont’d) Study population Eligibility criteria Provide rationales for inclusion and exclusion criteria (see Example 5). Provide rationales for control groups. Subject recruitment, enrollment, and retention. Describe sources of eligible subjects. Describe methods for identifying; contacting; and enrolling subjects, including obtaining informed consent.

10. Research Design and Methods (cont’d) Study procedures: provide an overview of the following: Number of study visits Where study visits will take place Types of data that will be collected Who will collect data or perform procedures Where specimens will be stored/analyzed

11. Research Design and Methods (cont’d) Study measurements Organize and categorize them by Specific Aim, or How they will be used analytically: predictor variables outcome variables confounding variables Provide rationales for your choice if several options are available. Limit the amount of technical detail.

12. Research Design and Methods (cont’d) Data quality and management Issues that could be included: Staff training Quality audits Missing data Data analysis Hypothesis testing Sample size calculations Expected findings Data interpretation

13. Research Design and Methods (cont’d) Potential problems and alternative approaches Openly recognizing any inherent holes or pitfalls in your research plan can “show maturity.” It is entirely appropriate to acknowledge weaknesses and to present alternative plans. It is a common and costly mistake to leave this kind of information out of your research plan. Timeline: Indicate when each specific aim will be implemented and completed. Emphasize feasibility of accomplishing all specific aims within timeframe and resources requested (see Example 6).

14. Abstract Project Summary and Relevance Provide an abstract of the whole application (candidate, environment, and research). Include the candidate’s immediate and long-term career goals, research career development plan, and a description of the research project. Using no more than 2 or 3 sentences, describe the relevance of this research to public health. Be succinct and use plain language that can be understood by a general, lay audience. See Example 7.

15. 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 ( see Example 8 ). The study section will assess 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 will be factored into the overall score for scientific and technical merit.

16. Budget Issues Mentored K awards provide salary support for the candidate (usually $75,000/year) plus $25,000 to $50,000/year to cover the costs of the proposed training and research. The amount of salary support and funds for research/training may differ by institute. You may not receive salary support from federally funded sources in Years 1 – 3 of the K award, although you may be a principal investigator on your own R01, R03, or R21 in Years 4 and 5.

17. Budget Issues (cont’d) A detailed, itemized budget is not required by NIH, although you do have to provide a justification if you are requesting more than $25,000/year for research/training expenses. See Example 9. However, an itemized, detailed budget is required for internal review by UCSF, although it is not included in the grant application submitted to NIH. See Example 10.

18. Biosketches This section must include the biographical sketches of all Key Personnel and Other Significant Contributors. 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.

19. Resources Describe the facilities used to conduct the research (see Examples 11 and 12). Indicate performance sites and describe capacities, pertinent capabilities, relative proximity, and extent of availability to the project. If research involving “Special Agents” will occur, the biocontainment resources available at each site should be described.

20. Task List Develop a list of all components of your grant application package, including those required by the UCSF Office of Sponsored Research (OSR). See Example 13. Indicate who is responsible for completing each component. Develop this list in collaboration with your RSA (research support analyst), who will help you compile the grant application for submission to the OSR and NIH.