WRITING GRANT PROPOSALS IN EPIDEMIOLOGY, PREVENTIVE MEDICINE, AND BIOSTATISTICS

Cover
Half Title
Title Page
Copyright Page
Table of Contents
Preface to 2nd Edition
Author Bio
Chapter 1 Ten Top Tips for Successful Grant Proposal Writing
	1.1 Tip #1: Start Small but Have a Big Vision
	1.2 Tip #2: Focus on Small Grants Targeted to Early-Career Investigators
		1.2.1 Early-Career Awards and Postdoctoral Granting Mechanisms Provide the Highest Chances for Success
		1.2.2 Putting Tips #1 and #2 into Action: An Example
		1.2.3 A Pitfall to Avoid: Interdependent Aims
		1.2.4 Plan for More Than One Potential Funding Pipeline
	1.3 Tip #3: Look at Who and What They Funded before You
	1.4 Tip #4: Spend Half Your Time on the Specific Aims and Project Summary/Abstract
	1.5 Tip #5: Show That You Can Pull It Off
	1.6 Tip #6: Your Methods Should Match Your Aims and Vice Versa
	1.7 Tip #7: A Proposal Can Never Have Too Many Figures or Tables
	1.8 Tip #8: Seek External Review Prior to Submission
	1.9 Tip #9: Be Kind to Your Reviewers
		1.9.1 Subheadings Should Match Review Criteria
		1.9.2 Highlight Key Sentences
	1.10 Tip #10: If At All Possible, Choose a Topic That You Find Interesting!
Part I Preparing to Write the Grant Proposal
	Chapter 2 Setting up a Time Frame
		2.1 How to View the Submission Process Overall
		2.2 Getting Started
		2.3 Timeline for Submission of an NIH Grant
		2.4 Get Institutional Help
		2.5 Begin to Assemble the Research Team Early
			2.5.1 How to Choose Collaborators
			2.5.2 Common Pitfalls to Avoid
		2.6 Consider a Multiple Principal Investigator Model
		2.7 Establish Working Relationships with Coinvestigators before Submission
		2.8 Spend Half Your Time on the Specific Aims and Project Summary/Abstract
		2.9 Solicit the Non-Scientific Forms Early in the Process
		2.10 Solicit Early Informal Feedback on Your Grant Proposal
		2.11 Allow Time for External Review Prior to Submission
			2.11.1 Chalk-Talk Forums
			2.11.2 Mock NIH Study Sections
		2.12 Anticipate Being Rejected
	Chapter 3 Identifying a Topic and Conducting the Literature Search
		3.1 How Do Literature Reviews for Grant Proposals Differ from Literature Reviews for Journal Articles?
		3.2 How Big a Research Gap Do I Need to Fill?
		3.3 The Literature Review Is an Iterative Process
		3.4 Step #1: Creating a Literature Review Outline
		3.5 Step #2: Searching for Literature (Dos and Don’ts)
			3.5.1 Choosing a Relevant Database
			3.5.2 What Type of Literature to Collect for Each Section of the Literature Review Outline
				3.5.2.1 i. Public Health Impact of the Outcome
				3.5.2.2 ii. Physiology of Exposure–Outcome Relationship
				3.5.2.3 iii. Epidemiology of Exposure–Outcome Relationship
			3.5.3 Should You Collect Epidemiologic Literature That Only Secondarily Evaluated Your Exposure–Outcome Relationship?
			3.5.4 Collecting Literature for an Effect Modification Hypothesis
			3.5.5 How to Start the Search
			3.5.6 What to Do When Your Search Yields Thousands of Hits
			3.5.7 What to Do If There Are Too Few Hits
			3.5.8 How to Retrieve Articles (Hits)
			3.5.9 How to Scan Articles for Relevance
			3.5.10 Evaluating Your References for Completeness
		3.6 Step #3: Organizing the Epidemiologic Literature—Summary Tables
			3.6.1 What Data Should I Include in a Summary Table?
			3.6.2 Tips to Make Your Summary Table Most Useful
			3.6.3 Reviewing the Table to Identify Research Gaps
			3.6.4 Should I Include the Summary Table in My Grant Proposal?
		3.7 Example Literature Review Outline and Summary Table
	Chapter 4 Choosing the Right Funding Source
		4.1 Part I: Developing Your Grant-Funding Plan
			4.1.1 Steps for Success
				4.1.1.1 Step #1: Locate a Mentor for Grantsmanship
				4.1.1.2 Step #2: Develop Your Overall Grantsmanship Goal
			4.1.2 Plan for a Steady Trajectory of Grants from Small to Large
				4.1.2.1 Avoid Classic Pitfall #1: Don’t Skip Straight to Large Funding Mechanisms
			4.1.3 Serve as a Co-Investigator on Established Teams or Consider a Multiple PI Grant
			4.1.4 Plan for More Than One Potential Funding Pipeline
		4.2 Part II: Funding Mechanisms for Early-Career Grants
			4.2.1 Focus on Grants Targeted to Early-Career Faculty and Postdoctoral Fellows
			4.2.2 Internal University Funding
			4.2.3 Foundation Grants
			4.2.4 Resources for Selecting the Right Funding Source
			4.2.5 Look at Who and What They Funded before You
			4.2.6 Look at Who Serves as Reviewers
		4.3 Part III: Step-By-Step Advice for Finding the Right Funding Source at NIH
			4.3.1 Step #1: Determine Which NIH Institute’s Mission Encompasses Your Topic
			4.3.2 Step #2: Choose a Funding Mechanism Sponsored by Your Selected NIH Institute
				4.3.2.1 Doctoral and Postdoctoral Fellowship Grants (F Series) “Ruth L. Kirschstein Individual National Research Service Award” (NRSA)
				4.3.2.2 Training Grants (T Series) “Ruth L. Kirschstein Individual National Research Service Award”
				4.3.2.3 Career Development Awards (K Series)
				4.3.2.4 Loan Repayment Programs
				4.3.2.5 Research Supplements
				4.3.2.6 Research Awards (R Series)
				4.3.2.7 Choosing between an R03 and an R21
				4.3.2.8 Early-Stage Investigator Advantages
			4.3.3 Step #3: Choose the Corresponding Funding Opportunity Announcement Number
				4.3.3.1 Read the FOA Carefully!
		4.4 Examples of Choosing the Right Funding Sources
			4.4.1 Example #1: A Postdoctoral Researcher Transitioning to Early-Career Faculty
			4.4.2 Example #2: An Early-Career Faculty Member
	Chapter 5 Scientific Writing
		5.1 Tip #1: Consider Your Audience
		5.2 Tip #2: Omit Needless Words
		5.3 Tip #3: Avoid Professional Jargon
		5.4 Tip #4: Avoid Using the First-Person Singular
		5.5 Tip #5: Use the Active Voice
		5.6 Tip #6: Use the Positive Form
		5.7 Tip #7: Avoid Using Synonyms for Recurring Words
		5.8 Tip #8: Use Transitions to Help Trace Your Argument
		5.9 Tip #9: Avoid Direct Quotations Both at the Beginning and within the Research Strategy
		5.10 Tip #10: Avoid Saying The Authors Concluded …
		5.11 Tip #11: Place Latin Abbreviations in Parentheses; Elsewhere Use English Translations
		5.12 Tip #12: Spell Out Acronyms When First Used; Keep Their Use to a Minimum
		5.13 Tip #13: Avoid the Use of Contractions
		5.14 Tip #14: Spell Out Numbers at the Beginning of a Sentence
		5.15 Tip #15: Placement of References
		5.16 Strive for a User-Friendly Draft
		5.17 Take Advantage of Writing Assistance Programs
		5.18 Solicit Early Informal Feedback on Your Proposal
			5.18.1 Solicit Feedback on Content, Not Just Style
		5.19 Who Must Read Your Proposal
		5.20 Incorporating Feedback
		5.21 How to Reconcile Contradictory Feedback
		5.22 Annotated Example: Needs Improvement
Part II The Grant Proposal: Section by Section
	Chapter 6 Specific Aims
		6.1 Purpose of the Specific Aims Page
		6.2 A Word of Caution
		6.3 Outline for the Specific Aims Page
			6.3.1 Goals of the Specific Aims Page
			6.3.2 Paragraphs #1–#2: Significance and Innovation
				6.3.2.1 A. Importance of the Topic
				6.3.2.2 B. How Previous Research Is Limited
				6.3.2.3 C. The Overall Goal of Your Proposal and How It Will Fill This Research Gap
			6.3.3 Paragraph #3: Highlights of the Approach (Methodology)
			6.3.4 Paragraph #4: Specific Aims and Corresponding Hypotheses
			6.3.5 Paragraph #5: Summary of Significance and Innovation
				6.3.5.1 Significance
				6.3.5.2 Innovation
				6.3.5.3 An Important Caveat
		6.4 When to Consider Discarding Your Original Aims and Hypotheses
		6.5 Should You Aim to Conduct Analytic or Descriptive Studies?
		6.6 Aims Involving the Use of an Existing Dataset—Pros and Cons
		6.7 How to Decide Whether to Include Exploratory or Secondary Aims
		6.8 Tip #1: How to Deal with the One-Page Limitation for the Specific Aims Page
		6.9 Tip #2: Do Not Propose Overly Ambitious Specific Aims
			6.9.1 Recommendation for a Feasible Topic for a First Grant
		6.10 Tip #3: Avoid Interdependent Aims
		6.11 Tip #4: Avoid Including Too Many Specific Aims
		6.12 Tip #5: If You Plan to Evaluate Effect Modification in Your Methods, Include It as a Hypothesis
		6.13 Tip #6: Remember That All Aims Should Be Accompanied by Hypotheses
		6.14 Tip #7: Consider Including a Figure in Your Specific Aims Page
		6.15 Annotated Examples
			6.15.1 Example #1: Needs Improvement
			6.15.2 Example #2: Does Not Need Improvement
	Chapter 7 How to Develop and Write Hypotheses
		7.1 Need for Hypotheses
		7.2 More about the Distinction between Hypotheses and Specific Aims
		7.3 Hypotheses Should Flow Logically from the Background and Significance Section
		7.4 How to Write Hypotheses If the Prior Literature Is Conflicting
		7.5 How to Write Hypotheses If the Prior Literature Is Null
		7.6 How to Write Hypotheses If the Prior Literature Is Sparse or Nonexistent
		7.7 Guideline #1: A Research Hypothesis Should Name the Independent and Dependent Variables and Indicate the Type of Relationship Expected between Them
		7.8 Guideline #2: A Hypothesis Should Name the Exposure Prior to the Outcome
		7.9 Guideline #3: The Comparison Group Should Be Stated If You Have a Categorical Exposure
		7.10 Guideline #4: When Your Study Is Limited to a Particular Population, Reference to the Population in Your Specific Aims and/or Hypotheses
		7.11 Guideline #5: Hypotheses Should Be as Concise as Possible and Use Measureable Terms
		7.12 Guideline #6: Avoid Making Precise Statistical Predictions in a Hypothesis
		7.13 Guideline #7: A Hypothesis Should Indicate What Will Actually Be Studied—Not the Possible Implications of the Study nor Value Judgments of the Author
		7.14 Guideline #8: Writing Hypotheses for an Effect Modification/Interaction Aim
		7.15 Stylistic Tip #1: When a Number of Related Hypotheses Are to Be Stated, Consider Presenting Them in a Numbered or Lettered List
		7.16 Stylistic Tip #2: Because Most Hypotheses Deal with the Behavior of Groups, Plural Forms Should Usually Be Used
		7.17 Stylistic Tip #3: Avoid Using the Words Significant or Significance in a Hypothesis
		7.18 Stylistic Tip #4: Avoid Using the Word Prove in a Hypothesis
		7.19 Stylistic Tip #5: Avoid Using Two Different Terms to Refer to the Same Variable in a Hypothesis
		7.20 Stylistic Tip #6: Remove Any Unnecessary Words
		7.21 Stylistic Tip #7: Hypotheses May Be Written as Research Questions—But Use Caution
		7.22 Hypothesis Writing Checklist
	Chapter 8 Significance and Innovation
		8.1 Refer Back to Your Literature Review Outline
		8.2 The Significance and Innovation Section Should Be Made Up of Subsections Corresponding to Each Hypothesis
			8.2.1 Consider Inserting a Figure at the Beginning of the Significance and Innovation Section
		8.3 Section A: Importance of the Topic
			8.3.1 Section A.i.: Public Health Impact of the Outcome
			8.3.2 Section A.ii.: Physiology of the Exposure–Outcome Relationship
			8.3.3 Section A.iii.: Epidemiology of the Exposure–Outcome Relationship
				8.3.3.1 Summarize the Prior Epidemiologic Literature
				8.3.3.2 Choosing Categories That Highlight the Research Gap
				8.3.3.3 Note the Relationships between Study Methods and Their Corresponding Findings
				8.3.3.4 What Should You Do if the Prior Literature Is Conflicting?
				8.3.3.5 Highlight Key Studies
		8.4 Section B: How Previous Research Is Limited (Research Gap)
			8.4.1 Highlight the Limitations of Prior Studies That Your Proposal Will Be Able to Address
			8.4.2 Express Your Own Opinions about a Prior Study’s Limitations
			8.4.3 You May Refer to Comments from a Review Article
		8.5 Section C: Summary of Significance and Innovation
		8.6 Stylistic Tips for Writing the Significance and Innovation Section
			8.6.1 Tip #1: Summarize Key Sentences in Bold
			8.6.2 Tip #2: Avoid Broad and Global Statements
			8.6.3 Tip #3: Be Comprehensive and Complete in Citations
			8.6.4 Tip #4: Citations Should Directly Follow the Studies That They Relate To
			8.6.5 Tip #5: If You Are Commenting on a Time Frame, Be Specific
		8.7 Annotated Examples of the Significance and Innovation Section
			8.7.1 Example #1: Section A. iii.: Epidemiology of Exposure–Outcome Relationship
			8.7.2 Example #2: Section I.: Significance and Innovation
			8.7.3 Example #3: Section I.: Significance and Innovation
	Chapter 9 Preliminary Studies
		9.1 What Are Preliminary Studies?
		9.2 Where to Place Preliminary Studies in an NIH Grant Proposal
		9.3 Start by Describing Your Research Team
		9.4 How to Describe Preliminary Data
		​9.5 Link Each of Your Preliminary Studies to Your Proposed Specific Aims/Hypotheses
		9.6 Preliminary Studies Should Not Fully Answer Your Proposed Research Questions
		9.7 Should I Include Preliminary Studies Even If the Grant Does Not Require Them?
		9.8 Do Preliminary Data Need to Be Previously Published?
		9.9 Preliminary Studies Based on Existing Datasets
		9.10 What If Your Preliminary Data Contradict Your Proposed Hypotheses?
		9.11 What If You Do Not Have Preliminary Data?
		9.12 Tip #1: Include Tables and Figures in the Preliminary Studies Section
		9.13 Tip #2: When Describing Results in a Table or Figure, Point Out the Highlights for the Reviewer
		9.14 Tip #3: How to Create Descriptive Tables of the Study Population
		9.15 Tip #4: Describe Preliminary Findings in Layperson’s Terms
			9.15.1 How to Describe a Beta Coefficient in Layperson’s Terms
			9.15.2 How to Describe Effect Modification in Layperson’s Terms
		9.16 Tip #5: Describe Tables in Numeric Order
		9.17 Tip #6: Try to Describe Tables from Top to Bottom
		9.18 Tip #7: Spell Out Numbers That Start Sentences
		9.19 Tip #8: Avoid Presenting Confidence Intervals and p-Values
		9.20 Tip #9: Avoid Referring to Your Tables As Active Beings
		9.21 Tip #10: Tips for Table Titles
		9.22 Preliminary Study Examples
			9.22.1 Preliminary Study #1
			9.22.2 Preliminary Study #2
	Chapter 10 Pilot Grants: Reproducibility and Validity Studies
		10.1 Why Conduct a Reproducibility or Validity Study?
		10.2 What Is Reproducibility?
		10.3 What Is Validity?
		10.4 Relationship between Reproducibility and Validity
		10.5 Both Subjective and Objective Measurement Tools Require Evidence of Reproducibility and Validity
			10.5.1 Questionnaires
			10.5.2 Particular Challenge of Behavioral Questionnaires
			10.5.3 Objective Measures Also Require Reproducibility and Validity Studies
		10.6 Study Design of Reproducibility Studies
		10.7 Study Design of Validity Studies
			10.7.1 Subjective Comparison Measures
			10.7.2 Objective Comparison Measures
			10.7.3 Number of Administrations of the Comparison Measure
		​10.8 Writing Data Analysis Sections for Reproducibility/Validity Studies
		10.9 Writing Limitations Sections for Reproducibility/Validity Studies
			10.9.1 Threats to Observed Reproducibility Scores
			10.9.2 Threats to Observed Validity Scores
			10.9.3 Threats to Generalizability
		10.10 How to Interpret Findings from Reproducibility/Validity Studies
		10.11 Issues of Sample Size and Power for a Reproducibility and Validity Study
		10.12 Summary
		10.13 Example
	Chapter 11 Study Design and Methods
		11.1 Outline for the Study Design and Methods Section
		11.2 Overall Strategy
			11.2.1 Note for Applications Which Use Substantively Different Methods for Each Specific Aim
		11.3 Identify Benchmarks for Success
		11.4 Section i: Study Design
			11.4.1 Consider a Study Design Figure
		11.5 Section ii: Study Population Characteristics
			11.5.1 How to Describe Your Study Setting
			11.5.2 How to Describe Your Recruitment and Retention Plan
			11.5.3 How to Describe Eligibility Criteria
		11.6 Section iii: Exposure Assessment
			11.6.1 How Your Exposure Data Will Be Collected
			11.6.2 Exposure Parameterization
			11.6.3 Validity of Exposure Assessment—Subjective Measures
			11.6.4 Validity of Exposure Assessment—Objective Measures
			11.6.5 What to Do if There Are No Prior Validation Studies
		11.7 Section iv: Outcome Assessment
		11.8 Section v: Covariate Assessment
		11.9 Section vi: Variable Table
		11.10 NIH Guidance on Rigor and Reproducibility
		11.11 Pitfall to Avoid
		11.12 Example Study Design and Methods Sections
			11.12.1 Example #1
			11.12.2 Example #2
	Chapter 12 Data Analysis Plan
		12.1 Part I: Framework for the Proposed Data Analysis Plan
			12.1.1 Start the Data Analysis Plan by Repeating Your Specific Aims Verbatim
			12.1.2 What If All Your Aims Require the Identical Data Analysis Plan?
		12.2 Part II: Scope and Depth of Proposed Analyses
			12.2.1 Step #1: Are Your Specific Aims Descriptive or Analytic?
			12.2.2 Step #2: How Will You Parameterize Your Variables?
		12.3 Outline for a Basic Data Analysis Plan
			12.3.1 Univariate Analysis Plan
			12.3.2 Bivariate Analysis Plan
			12.3.3 Multivariable Analysis Plan
				12.3.3.1 Select an Appropriate Model
				12.3.3.2 Specify How the Model Will Adjust for Potential Confounding Factors (i.e., Covariates)
				12.3.3.3 Specify How You Will Evaluate Potential Effect Modifiers
			12.3.4 Exploratory Data Analyses
		12.4 Part III: Best Practices
		12.5 Example Data Analysis Plan
	Chapter 13 Power and Sample Size
		13.1 Timeline
		13.2 What Is Power?
		13.3 Key Characteristics of Power
		13.4 When Is It Ok Not to Include a Power or Sample Size Calculation?
		13.5 Do I Need to Include a Power or Sample Size Calculation When I Am Proposing a Secondary Analysis of an Existing Dataset?
		13.6 Step #1: Estimate Your Sample Size
		13.7 Step #2: Choose User-Friendly Software to Calculate Power
		13.8 Step #3: Remind Yourself of Your Measure of Association
		13.9 Step #4: Calculate Power for Ratio Measures of Association (i.e., Relative Risks)
			13.9.1 For Cohort and Cross-Sectional Studies
			13.9.2 For Unmatched Case-Control Studies
		13.10 Step #5: Calculate Power for Difference Measures of Association (i.e., Continuous Outcome Variables)
		13.11 How to Display Your Power in the Proposal
			13.11.1 Display Your Power for a Range of Relative Risks
			13.11.2 Display Your Power for a Range of Exposure Distributions and Outcome Frequencies
			​13.11.3 Display Your Power for a Range of Sample Sizes
			13.11.4 Display Your Power for a Continuous Outcome Variable
		13.12 What if Your Power Is Not Adequate?
		13.13 How to Adjust Your Sample Size Upwards to Account for Missing Data
		13.14 Other Factors that Influence Power
		13.15 Final Pep Talk
		13.16 Example
	Chapter 14 Study Limitations to Consider
		14.1 Study Limitations: Chance, Bias, and Confounding
		14.2 Chance
		14.3 Bias
		14.4 Nondifferential Misclassification
			14.4.1 Nondifferential Misclassification of Exposure
			14.4.2 Nondifferential Misclassification of Outcome
		14.5 Selection Bias
			14.5.1 Selection Bias in a Case-Control Study
			​14.5.2 Selection Bias in a Cohort Study
		14.6 Information Bias
			14.6.1 Information Bias in a Case-Control or Cross-Sectional Study
			​14.6.2 Information Bias in a Cohort Study
		​14.7 Confounding
			14.7.1 Confounding in Randomized Trials
			14.7.2 Difference between Confounding and Effect Modification
			14.7.3 Will You Be Missing Information on Any Potential Confounding Factors?
		14.8 Other Limitations Specific to Cross-Sectional and Case-Control Studies
		14.9 Generalizability
			14.9.1 Reasons to Limit Generalizability
		14.10 Exercises
		14.11 Issues for Critical Reading
		14.12 Examples
			14.12.1 Example #1
			14.12.2 Example #2
	Chapter 15 How to Present Limitations and Alternatives
		15.1 Part I: How to Strategically Present Limitations—A Fourfold Approach
			15.1.1 Step #1: Describe the Potential Limitation
			15.1.2 Step #2: Describe the Potential Impact of the Limitation on Your Study Findings
			15.1.3 Step #3: Discuss Alternatives
			15.1.4 Step #4: Describe Methods to Minimize the Limitation
			15.1.5 Conclusion to Fourfold Approach to Address Limitations: Putting It All Together
		15.2 Where to Place Your Study Limitations in a Grant Proposal
			15.2.1 Limitations Section at the End of the Approach Section
			15.2.2 Intermingled Limitations Sections
		15.3 Part II: Methods to Minimize Classic Limitations—Design and Analysis Techniques
			15.3.1 Methods to Minimize Nondifferential Misclassification
				15.3.1.1 Design Techniques to Minimize Nondifferential Misclassification
				15.3.1.2 Analysis Techniques to Minimize Nondifferential Misclassification
			15.3.2 Methods to Minimize Selection Bias
				15.3.2.1 Study Design and Analysis Techniques to Minimize Selection Bias
			15.3.3 Methods to Minimize Information Bias
				15.3.3.1 Study Design Techniques to Minimize Information Bias
				15.3.3.2 Analysis Techniques to Minimize Information Bias
			15.3.4 Methods to Minimize Confounding
				15.3.4.1 Study Design Techniques to Minimize Confounding
				15.3.4.2 Analysis Techniques to Minimize Confounding
				15.3.4.3 Techniques to Minimize Lack of Data on a Confounder
			15.3.5 Methods to Minimize Survivor Bias
			15.3.6 Methods to Minimize Temporal Bias
			15.3.7 Methods to Minimize Lack of Generalizability
		15.4 Examples of Methods to Minimize Limitations
			15.4.1 Example #1
			15.4.2 Example #2
	Chapter 16 Project Summary/Abstract
		16.1 Outline for Project Summary/Abstract
		16.2 Strategies for Meeting the Word Count/Line Limitations
		16.3 When to Finalize the Project Summary/Abstract
		16.4 NIH Review of a Project Summary/Abstract
		16.5 Examples of Funded Abstracts
		16.6 Abstract: Step by Step
		16.7 I. Significance and Innovation
			16.7.1 A. Importance of the Topic
				16.7.1.1 i. Public Health Impact of the Outcome (Disease)
				16.7.1.2 ii. Physiology of the Exposure–Outcome Relationship
				16.7.1.3 iii. Epidemiology of the Exposure–Outcome Relationship
			16.7.2 B. How Previous Research Is Limited (Research Gap)
			16.7.3 C. The Overall Goal of Your Proposal and How It Will Fill This Research Gap
		16.8 II. Highlights of the Approach (Methodology)
			16.8.1 What if You Plan to Use Substantively Different Methods to Achieve Individual Specific Aims
		16.9 III. Overall Goal, Specific Aims, and Hypotheses
		16.10 IV. Summary of the Significance and Innovation
		16.11 How to Write a Title for Your Proposal
			16.11.1 Tip #1: Use Agency-Friendly Keywords
			16.11.2 Tip #2: Titles Should Include the Key Variables Being Evaluated
			16.11.3 Tip #3: The Title Should Not State the Expected Results of the Proposed Study
			16.11.4 Tip #4: Titles Should Mention the Study Design If a Strength
			16.11.5 Tip #5: The Title Should Mention the Study Population When Important
			16.11.6 Tip #6: Titles Should Mention Any Other Unique Features of the Study
			16.11.7 Tip #7: The Title Should Be Consistent with the Overall Study Goal
			16.11.8 Stylistic Tip #1: Avoid Clever Titles
			16.11.9 Stylistic Tip #2: Avoid Writing Titles as Questions
		16.12 How to Write a Project Narrative for Your Proposal
		16.13 Examples
			16.13.1 Example #1a: Needs Improvement
			16.13.2 Example #1b: Improved Project Summary/Abstract
Part III Submission and Resubmission
	Chapter 17 Submission of the Grant Proposal
		17.1 Components of the Grant Proposal Submission
		17.2 Overall Formatting Guidelines
			17.2.1 Tips for Success
		17.3 Section I: Selected Scientific Forms
			17.3.1 PHS Human Subjects and Clinical Trials Information Form
				17.3.1.1 Section 2: 2.3a Inclusion of Individuals across the Lifespan
				17.3.1.2 Section 2: 2.4 Inclusion of Women and Minorities
				17.3.1.3 Section 2: 2.5 Recruitment and Retention Plan
				17.3.1.4 Section 2: 2.7 Study Timeline
				17.3.1.5 Section 2: 2.9 Inclusion/Enrollment Report
				17.3.1.6 Section 3: 3.1 Protection of Human Subjects
				17.3.1.7 Data and Safety Monitoring Plan
			17.3.2 Bibliography and References Cited
		17.4 Section II: Nonscientific Forms
			17.4.1 SF 424 (R&R) Form and Other Forms
			17.4.2 Facilities and Other Resources
			17.4.3 Equipment
			17.4.4 Biosketch
			17.4.5 Budget and Budget Justification
			17.4.6 Multiple Principal Investigator Leadership Plan
			17.4.7 Resource Sharing Plan
			17.4.8 Authentication of Key Biological and/or Chemical Resources
			17.4.9 Appendix
			17.4.10 PHS Assignment Request Form
		17.5 Sections III, IV, V: Items Needed from Collaborators
			17.5.1 Biosketches
			17.5.2 Letters of Support from Co-investigators and Consultants
			17.5.3 Items Needed from Subcontractors (at Other Institutions)
		17.6 Setting Up a Time Frame
	Chapter 18 Fellowship Grants
		18.1 Are You a Good Candidate for a Fellowship Grant?
			18.1.1 Consider if You Have a Strong Mentorship Team at Hand
			18.1.2 Consider Your Experience Thus Far
			18.1.3 Eligibility
			18.1.4 Consider the Benefits of a Fellowship Grant
			18.1.5 Before You Make a Final Decision
		18.2 Outline of a Fellowship Grant Application
		18.3 Project Summary/Abstract
		18.4 Applicant’s Background and Goals for Fellowship Training
			18.4.1 A. Doctoral Dissertation and Research Experience
			18.4.2 B. Training Goals and Objectives
				18.4.2.1 Example Training Goals
			18.4.3 C. Activities Planned under This Award
				18.4.3.1 Training Plan
				18.4.3.2 Example Training Activities
				18.4.3.3 Table of Training Activities over Time
		18.5 Research Training Plan: Specific Aims and Research Strategy
			18.5.1 Tips for Success for the Research Strategy for a Fellowship Grant
		18.6 Respective Contributions
		18.7 Selection of Sponsor and Institution
		18.8 Training in the Responsible Conduct of Research
		18.9 Sponsor and Co-Sponsor Statements
			18.9.1 A. Sponsor’s and Co-Sponsor’s Research Support Available
			18.9.2 B. Sponsor’s and Co-Sponsor’s Previous Fellows/Trainees
			18.9.3 C. Training Plan, Environment, and Research Facilities
				18.9.3.1 Individualized Development Plan
				18.9.3.2 The Training Environment and Research Facilities
			18.9.4 D. Fellows/Trainees to Be Supervised by Sponsor
			18.9.5 E. Applicant Qualification and Potential for a Research Career
		18.10 Letters of Support from Collaborators, Contributors, and Consultants
		18.11 Reference Letters
		18.12 Institutional Environment and Commitment to Training
		18.13 PHS Human Subjects and Clinical Trials Information
		18.14 Facilities and Other Resources
		18.15 Biographical Sketches
			18.15.1 The Personal Statement
			18.15.2 Positions, Scientific Appointments, and Honors
			18.15.3 Contributions to Science
			18.15.4 Scholastic Performance
		18.16 Budget
		18.17 Timeline for Writing
		18.18 Final Pep Talk
	Chapter 19 Career Development Awards
		19.1 Are You a Good Candidate for a Career Development Award?
			19.1.1 Consider If You Have a Strong Mentorship Team at Hand
			19.1.2 Eligibility
			19.1.3 Consider the Benefits of a Career Development Award
			19.1.4 Before You Make a Final Decision
		19.2 Outline of a Career Development Award Application
		19.3 Project Summary/Abstract
		19.4 Candidate Information and Goals for Career Development
			19.4.1 A. Candidate’s Background
			19.4.2 B. Career Goals and Objectives
				19.4.2.1 Example Training Goals
			19.4.3 C. Candidate’s Plan for Career Development/Training Activities during Award Period
				19.4.3.1 Mentorship Team
				19.4.3.2 Training Plan
				19.4.3.3 Example Training Activities
				19.4.3.4 Table of Training Activities with Corresponding Person-Months
		19.5 Research Plan: Specific Aims and Research Strategy
		19.6 Training in the Responsible Conduct of Research
		19.7 Plans and Statements of Mentor and Co-Mentor(s)
		19.8 Letters of Support from Collaborators, Contributors, and Consultants
		19.9 Reference Letters
		19.10 Institutional Commitment to Candidate’s Research Career Development
		19.11 Description of Candidate’s Contribution to Program Goals
		19.12 PHS Human Subjects and Clinical Trials Information
		19.13 Facilities and Other Resources
		19.14 Biographical Sketch
		19.15 Budget
		19.16 Timeline for Writing
		19.17 Final Pep Talk
	Chapter 20 Review Process
		20.1 Part I: Review Process
			20.1.1 Immediately after Submission: eRA Commons Confirmation
			20.1.2 Scientific Review Group (Study Section)
			20.1.3 Role of the Scientific Review Officer
				20.1.3.1 SRO’s Roles and Responsibilities
			20.1.4 Study Section Reviewers
			20.1.5 How the Study Section Members Review Your Grant Application
			20.1.6 Scoring: The NIH Rating Scale
			20.1.7 During the Study Section Meeting
			20.1.8 After the Study Section Meeting
			20.1.9 Tips for a Successful Review
		20.2 Part II: Once You Receive Your Scores
			20.2.1 Step #1: Read the Summary Statement
			20.2.2 If Your Application Was Streamlined (Unscored)
			20.2.3 Step #2: Contact Your Program Director
			20.2.4 Appeal
			20.2.5 Funding: What Determines Which Awards Are Made?
			20.2.6 “Bubble Grants”—on the Cusp of the Pay Line
		20.3 Appendix: Review Criteria
			20.3.1 Review Criteria for Research Grants (R Series)
				20.3.1.1 Overall Impact
				20.3.1.2 Significance
				20.3.1.3 Investigators
				20.3.1.4 Innovation
				20.3.1.5 Approach
				20.3.1.6 Environment
			20.3.2 Review Criteria for Fellowship Grants (F Series)
				20.3.2.1 Overall Impact/Merit for a Fellowship Grant
				20.3.2.2 Fellowship Applicant
				20.3.2.3 Sponsors, Collaborators, and Consultants
				20.3.2.4 Research Training Plan
				20.3.2.5 Training Potential
				20.3.2.6 Institutional Environment and Commitment to Training
				20.3.2.7 Additional Review Considerations: Training in the Responsible Conduct of Research
			20.3.3 Review Criteria for Research Career Development Awards (K Series)
				20.3.3.1 Overall Impact for a Career Development Award
				20.3.3.2 Candidate
				20.3.3.3 Career Development Plan/Career Goals and Objectives
				20.3.3.4 Research Plan
				20.3.3.5 Mentor, Co-Mentor, Consultants, and Collaborators
				20.3.3.6 Environment and Institutional Commitment to the Candidate
	Chapter 21 Resubmission of the Grant Proposal
		21.1 Part I: Pathway to Resubmitting
			21.1.1 Whether to Resubmit
			21.1.2 If Your Application Was Streamlined (Unscored)
			21.1.3 Contact Your Program Director
			21.1.4 Timing of a Resubmission
			21.1.5 Not All Reviewer Comments Are Equal
			21.1.6 How Much Revision Is Necessary
			21.1.7 Study Section Review of Resubmission
		21.2 Part II: Introduction to the Resubmission
			21.2.1 General Format of the Introduction Page
				21.2.1.1 First Paragraph of the Introduction
				21.2.1.2 Bulk of the Introduction
				21.2.1.3 Last Paragraph of the Introduction
			21.2.2 Tip #1: Resist the Urge to Defend Yourself
			21.2.3 Tip #2: Avoid Disagreeing with a Reviewer
			21.2.4 Tip #3: If You Must Disagree with a Reviewer, Focus on the Science
			21.2.5 Tip #4: Avoid Using Cost or Logistics as a Rationale for Not Being Responsive to a Reviewer Comment
			21.2.6 Tip #5: Multiple-Bullet-Point Response to Major Concerns Is Highly Responsive
			21.2.7 Tip #6: Acknowledge Your Mistakes or Lack of Clarity
			21.2.8 Tip #7: Don’t Skip Any Reviewer Comments
			21.2.9 Tip #8: Avoid Collapsing Too Many Reviewer Concerns into One Bullet Point
			21.2.10 Tip #9: What about Areas That Reviewers Did NOT Comment On?
			21.2.11 Tip #10: Be Sure to Make Changes to the Body of the Proposal
			21.2.12 Stylistic Tip #1: Use Active (Not Passive) Voice
			21.2.13 Stylistic Tip #2: Avoid Use of the First Person
			21.2.14 Stylistic Tip #3: Don’t Waste Too Much Space Apologizing
		21.3 Part III: Body of the Resubmission
			21.3.1 How to Identify Revisions to a Grant Proposal
			21.3.2 Review the Published Literature for Recent Relevant Publications
			21.3.3 Obtain Revised Letters of Collaboration
			21.3.4 Update Biosketches: Both Your Own and Those of Your Coinvestigators
		21.4 Resubmission of a Fellowship Grant
		21.5 Resubmission of a Career Development Award
		21.6 Examples
			21.6.1 Example Introduction to the Resubmission of an R01 Proposal to Conduct a Randomized Trial of a Postpartum Diabetes Prevention Program
			21.6.2 Example Introduction to the Resubmission of a Career Development Award (K01) Proposal to Conduct a Web-Based Intervention Study to Prevent Weight Gain in Men
			21.6.3 Example Introduction to the Resubmission of a Fellowship Grant (F31) Proposal to Conduct a Cohort Study of Physical Activity (PA) and Neonatal Anthropometric Measures
Index