Creating a Research Plan for a Career Development Award Jill Harkavy-Friedman, Ph.D.

Creating aResearch Plan for a Career Development Award

Jill Harkavy-Friedman, Ph.D.

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A Sound Research Plan is: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 consultation with mentor(s).

Review of Research PlanReview 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 are judged in the context of the candidate's previous training and experience

Review TemplateReview Template

3. Research Plan Please limit text to ¼ page

Strengths

Weaknesses

Developing Your Research PlanDeveloping 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.

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.

Research Plan MustResearch 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.

Components of Research PlanComponents of Research Plan

1. Specific Aims2. Significance3. Innovation4. Preliminary Studies/Progress Report5. Approach6. Bibliography and References Cited/Progress Report Publication List7. Protection of Human Subjects8. Inclusion of Women and Minorities9. Targeted/Planned Enrollment Table10. Inclusion of Children11. Vertebrate Animals12. Select Agent Research13. Multiple PD/PI Leadership Plan14. Consortium/Contractual Arrangements15. Letters of Support (e.g., Consultants) 16. Resource Sharing Plan(s): over $500,000; model organism; GWAS

Specific AimsSpecific 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

Specific Aims are limited to one page.

Specific AimsSpecific 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

Specific Aims must be:Specific Aims must be:

Logical

Achievable

Testable

Hypothesis Based

Interesting and Important

One page

Examples of Objectives in Examples of Objectives in Specific AimsSpecific Aims

to test a stated hypothesiscreate a novel designsolve a specific problemchallenge an existing paradigm or clinical practiceaddress a critical barrier to progress in the fielddevelop new technology.

SignificanceSignificance

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.

SignificanceSignificance

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

BY THE TIME YOU GET TO THE METHODS THE READER BY THE TIME YOU GET TO THE METHODS THE READER SHOULD BELIEVE THAT THE VARIABLES AND GROUPS IN SHOULD BELIEVE THAT THE VARIABLES AND GROUPS IN

YOUR STUDY ARE ESSENTIAL TO STUDY. YOUR STUDY ARE ESSENTIAL TO STUDY.

THIS IS BASED ON SIGNIFICANCE AND AIMSTHIS IS BASED ON SIGNIFICANCE AND AIMS

InnovationInnovation

Explain how the application challenges current research or clinical practice paradigms. Do not disparage work that has come before

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.

ApproachApproach

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.

NoteNote

“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.”

Most reviewers prefer the collective format

Research DesignResearch 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

SampleSample

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

Remember to be:Remember to be:

SpecificRealisticExplicit about implications of your sample choice

Description of measuresDescription of measures

What you want to measureScale you will useDescription of scale and derived measure and range Derived measure is number you analyze

Benefits over other popularly used measures (rationale)Known reliability and Validity (Psychometric properties)

Is there a difference?Is there a difference?

POWER IS KNOWLEDGEPOWER IS KNOWLEDGE

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.

Power and Sample Size Table at Power and Sample Size Table at αα 1=.05 1=.05

ES .30 .40 .50 .60

Power

.70 108 62 41 29

.75 123 70 46 33

.80 140 80 52 37

.85 163 93 61 43

.90 193 110 72 51

.95 243 138 90 63

.99 353 200 129 91

Statistical Analysis Statistical Analysis

First describe how you will examine the data set Distributions, means and SD’s and graphic depiction

Testing for possible control variablesData reductionHypothesis IHypothesis IIExploratory analyses

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

Time LineTime Line

Year 1 Year 2 Year 3 Year 4

Training

Study

Day after application Day after application submissionsubmission