Research Plan Development

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Creating a
Research Plan for a Career Development Award
Jill Harkavy-Friedman, Ph.D.
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
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For individuals with a research doctorate
For individuals with a health-professional doctorate
Career Award Data and Administrative Information
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Funded Career Development Awards
Career Award Application Success Rates
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 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 Template
3. Research Plan

Please limit text to ¼ page
Strengths
Weaknesses
Developing Your Research Plan
Describe the proposed research
Significance
 How it will be conducted
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2 audiences:
the majority will probably not be familiar with
your techniques or field
 a smaller number who will be familiar.
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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 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 Plan
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
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
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
Specific Aims are limited to one page.
Specific Aims
Intro and Specific Aims are completed in one page
Intro:
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Clinical issue and literature
Need for research study
Proposed design
Specific Aims:
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Goal
Method including variables
Hypothesis
Specific Aims must be:
Logical
Achievable
Testable
Hypothesis Based
Interesting and Important
One page
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 fielddevelop
new technology.
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.
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
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
Innovation
Explain how the application challenges current
research or clinical practice paradigms.
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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.
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.
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.”
Most reviewers prefer the collective format
Research Design
Sample
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Who, how many, recruitment, attrition
Measures
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Instrument for each construct, rationale, psychometric properties, derived measure
Procedure
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Step by step description of study
Power
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For each hypothesis: power, ES, significance, n
Statistics
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By hypothesis
Sample
N=?
# per group
 Individuals with …
 Stratification
 Random assignment
 Recruitment
 Attrition
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Remember to be:
Specific
Realistic
Explicit about implications of your sample
choice
Description of measures
What you want to measure
Scale you will use
Description of scale and derived measure and range
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Derived measure is number you analyze
Benefits over other popularly used measures
(rationale)
Known reliability and Validity (Psychometric
properties)
Is there a difference?
POWER IS KNOWLEDGE
Power: How likely are you to detect an effect?
Sample Size: n
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How many people will you need?
Effect Size: σ (e.g., R2)
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How much of a difference are you trying to detect?
Significance Level (Type I Error): α
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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)
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How much risk there is of saying that there is no difference when there is a difference.
Power and Sample Size Table at α 1=.05
ES
Power
.70
.30
.40
.50
.60
108
62
41
29
.75
.80
.85
.90
123
140
163
193
70
80
93
110
46
52
61
72
33
37
43
51
.95
.99
243
353
138
200
90
129
63
91
Statistical Analysis
First describe how you will examine the data set
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Distributions, means and SD’s and graphic depiction
Testing for possible control variables
Data reduction
Hypothesis I
Hypothesis II
Exploratory analyses
Describe variables your sample(s) and the variables
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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:
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examine intercorrelations of measures along domain
conduct principal component factor analysis
define criterion for applying factors vs. individual scales
Time Line
Year 1
Training
Study
Year 2
Year 3
Year 4
Day after application
submission
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