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Grant Writing K99/R00 and R01

Module by: Dr. Sujata Krishna. E-mail the author

Summary: Slides developed and used by Phyllis McBride, Ph. D. during her presentation on May 10th, 2011 at the NLM Professional Development workshop organized by Sujata Krishna, Ph.D., Curriculum coordinator for the GCC.

Grant Writing: K99/R00 and R01

Phyllis McBride, Ph.D.

NLM Professional Development

May 10, 2011

AGENDA

  • Walk through the web:
    • How to find the R01 parent announcement
    • How to find the R01 application package
  • Discuss the R01 Research Project Grant
  • Take a break
  • Discuss the NIH Pathway to Independence Award
  • Discuss strategies for success
  • Q&A

WHERE DO I BEGIN?

Where do I begin? Part 1

  • Establish a logical, organized, consistent process
  • Develop a good idea, then refine it into a great idea
  • Search for potential funding opportunities
  • Learn about the agency mission
    • Ensure that your project aligns with agency’s mission
    • Begin an iterative thinking and writing process
    • Discuss your idea with your colleagues
    • Discuss your idea with your program manager!

Begin early!

Allow time to become familiar with forms and proposal requirements

  • PHS 398 – Proposal proper
    • Downloaded from NIH
  • SF424 (R&R) – Administrative information
    • Downloaded from Grants.gov
  • Career Development Award Supplemental Form
    • Downloaded from Grants.gov

Research Project Grant

NIH R01 Parent Application

Research Project Grant (R01)

  • Stands as the original funding mechanism for NIH
  • Award suggests research independence
  • PurposeSupports a discrete, specified, circumscribed project related to the stated program interests of one or more NIH institutes or centers
    • 27 Institutes and Centers
    • Each Institute and Center has a specific research agenda
      • Often focuses on particular diseases or body systems

NIH Institutes and Centers

Research Project Grant (R01)

Key Features

  • Unsolicited application
    • Investigator drives the research
  • Eligibility
    • Individuals with skills, knowledge, and resources necessary to carry out the proposed research; does not require US citizenship
  • Budget
    • Costs appropriate for the project; allows direct costs of $250,000 per year or less
  • Project duration
    • Up to five (5) years
  • Grant cycle
    • Three opportunities to apply each year

NIH Standard Due Dates – Competing Applications

Application Package (R01)

Mandatory Documents (R01)

  • SF424 R&R Cover Component
  • SF424 R&R Project/Performance Site Location(s)
  • SF424 R&R Other Project Information
  • SF424 R&R Senior/Key Person Profile
  • PHS398 Cover Page Supplement
  • PHS398 Research Strategy
  • PHS398 Checklist

“Optional” Documents (R01)

  • PHS398 Cover Letter
  • PHS398 Modular Budget
  • PHS398 Budget
  • R&R Sub-award Budget Attachment(s) Form

Research Strategy (R01)

  • Introduction
  • Specific Aims
  • Research Strategy
    • Significance
    • Innovation
    • Approach

Introduction (R01)

Required only for resubmission and renewal applications]

Specific Aims (R01)

  • Limited to one (1) page
  • Considered the most important page in the entire application because it may be the only page that reviewers who are not assigned to evaluate your proposal may read
    • Must be able to stand alone
    • Must be clearly written
    • Must generate enthusiasm for the project
  • 1st paragraph:
    • Introduce the project
    • Educate the reviewer
    • Identify the gap in the knowledge and why it creates a problem
  • 2nd paragraph:
    • State your overall goal for the project
    • Explain your rationale
    • Present your central hypothesis (if possible)
  • 3rd paragraph:
    • Describe your qualifications, research environment
  • 4th paragraph:
    • Delineate your specific aims in bullet form
      • To test a stated hypothesis
      • To create a novel design
      • To solve a specific problem
      • To challenge an existing paradigm or clinical practice
      • To address a critical barrier to progress in the field
      • To develop new technology
  • 5th paragraph:
    • Highlight the project’s innovation, significance, and impact (i.e., short- and long-term benefits)

Research Strategy (R01)

  • Limited to 12 pages
  • Considered the heart of the proposal
  • Comprises three required subsections:
    • Significance (1-2 pages)
    • Innovation (2-2½ pages)
    • Approach (4-6 pages)
  • Also includes Preliminary Studies (3 pages)

Research Strategy – Organization (R01)

Research Strategy – Significance (R01)

  • 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

Research Strategy – Innovation (R01)

  • Explain how the application challenges and seeks to shift 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
  • Explain any refinements, improvements, or new applications or theoretical concepts, approaches, or methodologies, instrumentation, or interventions

Research Strategy – Approach (R01)

  • Most important part of the Research Strategy
  • Describe the overall strategy, methodology, and analyses to be used to accomplish each specific aim
  • Explain 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

Research Strategy – Prelim Studies (R01)

  • Select the best way to present preliminary studies
    • Include within one of the three main sections, i.e., significance, innovation, or approach
    • Include as a separate section
  • Provide an account of only those preliminary studies relevant to the proposed project
  • Determine how much preliminary data to include
  • Present the results in a logical order
  • Cite your own publications, if possible
  • State explicitly how the results relate to the proposed project

PATHWAY TO INDEPENDENCE

K99/R00 Parent Announcement

Pathway to Independence Award (Parent K99/R00)

NIH Pathway to Independence (K99/R00)

  • Purpose
    • To facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm
  • Project period and project costs are divided into two distinct phases
    • Phase 1: Mentored support (2 years)
      • Total cost per year should not exceed $90,000
      • Must commit 75% full-time professional effort (9 months)
      • May spend 25% time teaching, doing clinical work, etc. (3 months)
    • Phase 2: Independent scientist (3 years)
      • Total cost per year should not exceed $249,000
      • Must commit 75% full-time professional effort (9 months)
      • May spend 25% time teaching, doing clinical work, etc. (3 months)
  • Eligibility
    • Must have research or clinical doctorate
    • Cannot yet have more than 5 years of post-doctoral research training
    • Cannot yet have a tenure-track assistant professor position (or equivalent)
    • US citizenship or permanent residency is not required
  • Mentor
    • Should be full-time faculty at sponsor institution
    • Must have funded research related to selected research topic

Mandatory Documents (K99/R00)

  • SF 424 (R&R)
    • SF 424 (R&R) Cover Component
    • SF 424 (R&R) Project/Performance Site Locations
    • SF 424 (R&R) Other Project Information
    • SF 424 (R&R) Senior/Key Person
    • SF 424 (R&R) Detailed Budget
  • PHS 398
    • PHS 398 Cover Letter
    • PHS 398 Cover Page Supplement
    • PHS 398 Checklist
    • PHS 398 Career Development Award Supplemental Form

Career Development Award Supplemental Form (K99/R00)

  • Candidate Information (Total of 12 pages)
    • Candidate's Background
    • Career Goals and Objectives
    • Career Development/Training Activities During Award Period
    • Research Strategy
  • Training in the Responsible Conduct of Research (1 page)
  • Mentoring Plan (6 pages)
  • Statements of Support from Mentors, etc. (6 pages)
  • Environment and Institutional Commitment to Candidate (1 page)
  • Research Plan
    • Specific Aims
    • Research Strategy
      • Significance
      • Innovation
      • Approach
      • Also include Preliminary Studies
    • Inclusion Enrollment Report
      • If conducting clinical research
    • Progress Report Publications List
      • For renewal applications only
  • Human Subject Sections
    • Protection of Human Subjects
    • Inclusion of Women and Minorities
    • Targeted/Planned Enrollment
    • Inclusion of Children
  • Other Research Plan Sections
    • Vertebrate Animals
    • Select Agent Research
    • Consortium/Contractual Arrangements
    • Resource Sharing Plans
      • Data Sharing Plan
      • Sharing Model Organisms
      • Genome-Wide Association Studies
  • AppendixMay include the following in the Appendix:
    • Manuscripts and/or abstracts accepted for publication but not yet published
    • Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available
    • Patents directly relevant to the project
    • Surveys, questionnaires, and other data collection instruments; clinical protocols and informed consent documents

Strategies for Success

General Tips

#1 Strategy for Success

Read the instructions and then read the instructions again!

The large print giveth and the small print taketh away….

Strategies for Success

  • Discuss your research idea with your mentor, colleagues, and program manager
  • Request your reference letters early, and talk to your references about what needs to be included in them
  • Be realistic
    • Make sure your specific aims can be accomplished within the proposed time
    • Make sure – and explicitly state – that you have the appropriate resources to conduct the research (equipment, lab space)
  • Identify yourself as a new investigator
  • Organize your application in the required format
  • Convey the value of the research in plain language – clear, succinct, and professional
  • Be comprehensible to both scientists and the public
  • Ensure that your application is complete
  • Have zero tolerance for typos and other errors
  • Relay the potential impact of the research on health
  • Think like a reviewer
    • How would you rate your application?
    • Shore up any weak spots before submission

Acknowledgements

The GCC Professional Development Project

is supported by a grant to the

NLM Training Program in

Biomedical Informatics and Computational Biology

from the

National Library of Medicine

Grant #3T15LM007093-19S1

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