Catherine Alfano, Ph'D'

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Writing a Seamless Grant Application
Catherine Alfano, Ph.D. Office of Cancer
Survivorship National Cancer Institute,
DCCPS National Institutes of Health
Alfanoc_at_mail.nih.gov Diana Jeffery,
PhD. jefferyd_at_mail.nih.gov
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Objectives

• Review..
• How mechanism influences writing
• Components of a grant application
• Cover letter
• Significance/rationale
• Literature
• Theory, hypotheses, and aims
• Methods
• Human Subjects and DSM
• Limitations
• Budget
• Environment and research team

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Mechanism Choice

• Training (K)
• Mentoring, coursework, and special training
  should feed into proposed project
• Investigator initiated (Rs)
• Number of pages dictated by announcement
• Number of aims depend on whether R01, R13, R15,
  or R21
• Budget dictates whether prior approval for
  submission is needed
• Always discuss mechanism with Program Director

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Investigator Initiated vs. Funding Opportunity
Announcements

• Program announcements (PA) statement of
• ongoing research interest by
  Institute/Center
• No set-aside monies
• Given higher priority if scored in the fundable
  range
• Better positioned to get funding by exception
• Announced in the NIH Guide
• PAR means special review study section
• Request for applications (RFA) special research
  initiative-funds
• Set aside monies, and specially assembled review
  group
• One-time application no revisions/resubmissions

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Submitting Grant Applications to NIHElectronic
Submission

• Submission homepage
• http//era.nih.gov/ElectronicReceipt/
• Office of Sponsored Research
• http//era.nih.gov/ElectronicReceipt/preparing.htm
  
• Training
• http//era.nih.gov/ElectronicReceipt/training.htm
• Submission dates
• http//grants.nih.gov/grants/funding/submissionsch
  edule.htm

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Writing For Success

• Positive attitude
• Persistence
• Accepts criticism
• Organized
• Functions well on little sleep

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Cover Letter

• Read about Standing Study Sections, including
  committee members rostershttp//www.csr.nih.gov/R
  oster_proto/sectionI.asp
• Suggest in your cover letter where your
  application appears to have the best fit, e.g.,
• From my review of the CSR webpage, it appears
  that the focus of my proposed research
  corresponds to standing study section(e.g.,
  BMIO)
• Suggest the type of expertise that would be most
  helpful to review your application, e.g.,
• Expertise that might be useful in reviewing my
  application includes (e.g., nutritional science,
  psychometrics, cultural anthropology, nursing
  science, epidemiology)
• Indicate which Program Officer has been guiding
  you, give name, Branch/Office

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Typical Sequence for Proposal Development

• Overall purpose
• Significance/rationale
• Supporting literature
• Specific aims
• Theoretical model
• Progress report/preliminary studies
• Research plan, including HIPAA,
• human subjects, data safety monitoring
• Significance
• Budget and justification
• Biographical sketches
• Abstract

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Outline of Research Proposal

• Overall Purpose
• Succinct statement of the proposed research
• Significance/Rationale
• Consider using federal documents to support
  research focus
• Progress Reports by cancer site
  http//planning.cancer.gov/evaluation/reports.shtm
  l
• Presidents Cancer Panel reports
• http//deainfo.nci.nih.gov/advisory/pcp/pcp.htm
• NCI Directors 2010 bypass budget The Nations
  Investment in Cancer Research http//www.cancer.go
  v/ncicancerbulletin/021009/page4
• Cancer statistics and trends http//planning.cance
  r.gov/evaluation/reports.shtml

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Institute of Medicine Resources

• Cancer Care for the Whole Patient (2007)
• From Cancer Patient to Cancer Survivors Lost in
  Transition (2005)
• Saving Women's Lives Strategies for Improving
  Breast Cancer Detection and Diagnosis (2004)
• Meeting the Psychosocial Needs of Women with
  Breast Cancer (2004)
• Childhood Cancer Survivorship (2003)
• Improving Palliative Care (2003)
• Fulfilling the Potential of Cancer and Prevention
  and Early Detection (2003)
• Unequal Treatment Confronting Racial and Ethnic
  Disparities in Healthcare (2002)
• http//www.iom.edu/CMS/2955.aspx

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Outline of Research Proposal

• Literature search
• Use articles which directly support aims
• Current references, up to month of submission
• Look up publications of potential reviewers
• Hypotheses Specific Aims
• Rarely more than 3 overall hypotheses with 2-3
  sub-aims
• Operationalize definitions
• State null and/or alternative hypotheses
• Research Design
• Describe design (e.g., 3-group, cross-sectional,
  nested, cross-over)

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Outline, cont.

• Theoretical model(s)
• Essential in intervention level studies
• Non-essential for exploratory level studies
• If no model, explain why not
• When possible, use diagrams or figures to
  accompany text
• Assume the reviewer is unfamiliar with the chosen
  theory
• Theory constructs should be reflected in
  identified variables, assessment tools, and
  statistical analyses

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Outline, cont.

• Methods
• Setting
• Subject selection
• Power analysis for EACH aim Numerators/Denominator
  s - DESCRIBE POPULATION
• Describe who, when, where, why of recruitment
• Attrition procedures to minimize drop outs
• Procedures for recruiting hard-to-reach
  populations
• Measures
• Reliability validity, population norms
• Rationale for use, which constructs they measure

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Outline, cont.

• Procedures
• Detailed, in order
• Data Analysis
• Use highest order analysis
• In quantitative designs, use multivariate
  approach
• In qualitative designs, provide details of
  analysis, software, etc. assume that reviewers
  have no experience with qualitative methods
• Be consistent in analytic approach for aims
• Include a biostatistician in writing
• Provide mock tables or figures for major analyses

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Outline, cont.

• Potential results
• Implications for public health,
• community, individuals, and their families
• Describe how proposed research, if
• successful, will lead to future funding
  applications
• Limitations of study
• Describe how limitations will be addressed
• Dissemination of results how and to whom
• Oral presentations at professional conferences
• Peer-reviewed journals
• Offer participants opportunity to get results in
  lay language

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Outline, cont.

• Timeline
• Identify tasks for members of team
• Include start up time and time to document
  results and submit publications
• Tables
• Appendices (generally not being accepted SEE
  electronic instructions)
• Letters of support from mentors,
  co-investigators, deans, community leaders
• Table of Contents
• Human Subjects
• Population/Women/Children/Minorities table

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Outline, cont.

• Data Safety and Monitoring Plan
• If clinical trial, needs to have independent
  oversight board
• Describe how data will be protected
• Describe PIs role for assuring that all research
  team members will be trained to assure
  confidentiality of data
• Describe how adverse effects will be reported to
  agency and NIH
• HIPAA considerations
• Own institutions general guidelines (brief)

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The Abstract

• (Re)Write after completing
• body of the proposal
• Most read section of grant application
• Summary of the proposal
• 2 - 4 sentences - background
• 1 2 sentences - rationale
• 2 - 3 sentences - aims/objectives
• 1 sentence theoretical approach
• 5 - 7 sentences methods
• 1 - 2 sentences - implications for anticipated
• results and contribution to science

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Grant Writing Resources

• NIH Grant Tutorials
• http//www.nlm.nih.gov/ep/Tutorial.html
• Grant Writing Tips Sheet
• http//grants.nih.gov.grants/grant_tips.htm
• Division of Cancer Control Population Sciences
• The Theory Project helpful for overviews of
  theories used in behavioral research
• http//cancercontrol.cancer.gov/brp/health_theory_
  index.html
• Applying for cancer control grants
• http//cancercontrol.cancer.gov/funding_apply.html
  

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Questions?