K-Award Seminar Research Plan

1. K-Award SeminarResearch Plan October 9, 2013 Jill Harkavy Friedman, Ph.D.

2. Information for the NIH Extramural Grantee Community During the Lapse of Federal Government Funding SUBMISSION OF GRANT APPLICATIONS For the duration of the funding lapse, applicants are strongly encouraged not to submit paper or electronic grant applications to NIH during the period of the lapse. Adjustments to application submission dates that occur during the funding lapse will be announced once operations resume. For any applications submitted immediately prior to or during the funding lapse, here is what will happen. For electronic submissions through Grants.gov: Grants.gov will be open and can accept electronic applications. However, applications will not be processed by NIH until the eRA Systems are back on-line. NIH will ensure that all applications submitted within the two business days before or during the funding lapse will receive the full viewing window once the systems are back on-line.

3. K Kiosk - Information about NIH Career Development Awards • * K-Awards Across Institutes and Centers • - Institute and Center specific information with links to appropriate websites • * Career Award Wizard - Helps you select the right career award • * Visual Guide to NIH Career Development Awards • o For individuals with a research doctorate • o For individuals with a health-professional doctorate • * Career Award Data and Administrative Information • o Funded Career Development Awards • o Career Award Application Success Rates

4. Career development Awards (K Awards) for Individuals with a Health-Professional Doctorate

5. Career Development Awards (K Awards) for Individuals with a Research Doctorate

7. A Sound Research Plan is: • Consistent with the candidate's level of research development and objectives of his/her career development plan must be provided. • Organized as indicated in the Form SF424 and PSHS 398 Career Development Supplement Award • The result of consult with mentor(s).

8. Review of Research Plan * Regardless of level of experience or depth of the proposal a fundamentally sound research plan must be provided * Degree of relevance of the research plan to developing an independent research program focused * Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan. * Scientific and technical merit of the research question, design and methodology judged in the context of the candidate's previous training and experience

9. Review Template • 3. Research Plan Please limit text to ¼ page • Strengths • Weaknesses

10. Developing Your Research Plan • Describe the proposed research • Significance • How it will be conducted • 2 audiences: • the majority will probably not be familiar with your techniques or field • a smaller number who will be familiar.

11. * All reviewers are important to you because each reviewer gets one vote. * You must win over the assigned reviewers . They act as your advocates. * Write and organize your application so the primary reviewer can readily grasp and explain what you are proposing and advocate for your application.

12. Research Plan Must • Be a major component of the research career development plan • Relate the research to the candidate's scientific career goals • Describe how the research and other activities will launch an independent research career • Explain the relationship between the candidate’s research and the mentor’s ongoing research program.

13. Components of Research Plan • Specific Aims • Significance • Innovation • Preliminary Studies/Progress Report • Approach • Bibliography and References Cited/Progress Report Publication List • Protection of Human Subjects • Inclusion of Women and Minorities • Targeted/Planned Enrollment Table • Inclusion of Children • Vertebrate Animals • Select Agent Research • Multiple PD/PI Leadership Plan • Consortium/Contractual Arrangements • Letters of Support (e.g., Consultants) • Resource Sharing Plan(s): over $500,000; model organism; GWAS

14. Specific Aims • State precisely the goals of the proposed research and summarize the expected outcome(s) including the impact that the results of the proposed research will exert on the research field(s) involved. • List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. • Specific Aims are limited to one page.

15. Specific Aims Intro and Specific Aims are completed in one page Intro: Clinical issue and literature Need for research study Proposed design Specific Aims: Goal Method including variables Hypothesis The reader should be begging for this study

16. Specific Aims must be: Logical Achievable Testable Hypothesis Based Interesting and Important One page

17. Examples of Objectives in Specific Aims • to test a stated hypothesis • create a novel design • solve a specific problem • challenge an existing paradigm or clinical practice • address a critical barrier to progress in the field • develop new technology.

18. Aim and Hypothesis from Amy Margolis Aim 1: To examine the effects of prenatal exposure to widespread air pollutants (ETS, PAH) on learning capacities at 9-11 years of age. Hypothesis 1a: Greater prenatal exposure to ETS will be associated with lower scores on tests of discrete learning capacities, as measured by: domain-specific cognitive abilities; reading ability (decoding and comprehension); and mathematical computational ability. Hypothesis1b: Greater prenatal exposure to PAHs will be associated with lower scores on tests of discrete learning capacities, as measured by: domain-specific cognitive abilities; reading ability (decoding and comprehension); and mathematical computational ability.

19. Aims: Jasmine Project 1: Overall childhood serologic infection burden Aim 1.1: Estimate the prevalence of common childhood infections by repeated measures from first and last available sera measure.  We will examine the prevalence of 5 infections in a random set of 100 girls to find the most common infections to measure in the entire cohort for Project 2. Project 2: Overall childhood serologic infection burden and pubertal timing Aim 2.1: Examine whether serologic infection burden is associated with the age of onset of breast development. Aim 2.2: Examine whether serologic infection burden is associated with age of onset of menarche. Aim 2.3: If associations are observed in 2.1 and/or 2.2, to examine whether these associations are mediated by adiposity.

20. Significance Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

21. Significance • State the clinical problem and it’s importance • State the goals of the study and how they will be met • Describe the history of the problem & show your critical thinking • Describe what has been done to solve the problem that relates to your intervention & demonstrate your up-to-date knowledge • Describe the specific components of what you will do and literature to support • Lead the reader to believe that this is an important issue and this is the study that can answer the driving currently unanswered question

22. By the time you get to the methods the reader should believe that the variables and groups in your study are essential to study. This is based on Significance and Aims

23. Innovation • Explain how the application challenges current research or clinical practice paradigms. • Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.

24. Approach • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. • Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. • Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. • If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. • Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of Select Agents should appear in Item 18 below.

25. Note: • If an applicant has multiple Specific Aims, then the applicant may address Significance, Innovation and Approach for each Specific Aim individually, or may address Significance, Innovation and Approach for all of the Specific Aims collectively.

26. Research Design • Sample • Who, how many, recruitment, attrition • Measures • Instrument for each construct, rationale, psychometric properties, derived measure • Procedure • Step by step description of study • Power • For each hypothesis: power, ES, significance, n • Statistics • By hypothesis

27. Sample N=? # per group Individuals with … Stratification Random assignment Recruitment Attrition

28. Remember to be: • Specific • Realistic • Explicit about implications of your sample choice

29. Description of measures What you want to measure Scale you will use Description of scale and derived measure and range Benefits over other popularly used measures (rationale) Known reliability and Validity (Psychometric properties)

30. Measures Table from Amy

31. Is there a difference?

32. Power is Knowledge

33. Power: How likely are you to detect an effect? • Sample Size: n How many people will you need? • Effect Size: σ (e.g., R2) How much of a difference are you trying to detect? • Significance Level (Type I Error): α How much of a risk are you willing to take of saying there is a difference when there none? • Type II Error: β or (1- α) • How much risk there is of saying that there is no difference when there is a difference.

34. Power and Sample Size Table at α1=.05

35. Statistical Analysis • First describe how you will examine the data set • Distributions, means and SD’s and graphic depiction • Testing for possible control variables • Data reduction • Hypothesis I • Hypothesis II • Exploratory analyses

36. Describe variables your sample(s) and the variables • Frequency distributions and plots • determine if groups differ on measures • determine if sample characteristics measured are • related to these variable • determine if you will need to control for anything • indicate correction for multiple comparisons • Reliability of measures • Data Reduction: • examine intercorrelations of measures along domain • conduct principal component factor analysis • define criterion for applying factors vs. individual scales

37. Time Line Year 1 Year 2 Year 3 Year 4 Training Study