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PHS 398 Research Plan

PHS 398 Research Plan

PHS 398 Research Plan Form Template

*Highlighted Areas are required to be filled out

This should represent a sound approach to the investigation of an important biomedical research, behavioral research, technological, engineering, or scientific question, and be worthy of support under the stated criteria of the FOA.

  • It should be self-contained and written with the same care and thoroughness as papers for publication.

Introduction

An "Introduction to Application" attachment is required only if the type of application is resubmission or revision or if the FOA specifies that one is needed.

  • An introduction is not allowed for new or renewal applications.
  • Attach as PDF Follow formatting instructions [link to formatting]
  • Resubmissions – The introduction should:
    • summarize substantial additions, deletions, and changes to the application
      • Note: Individual changes do not need to be identified within other application attachments (e.g., do not highlight, color, bold or italicize changes in Research Strategy)
    • respond to the issues and criticism raised in the summary statement
    • be one page or less in length, unless specified otherwise in the FOA
      • Note: In a resubmission of a revision application, the same introduction must describe the nature and impact of the revision and summarize the changes made to the application since the last submission.

Formatting Instructions

 

Research Plan Section This section contains: Specific Aims, Research Strategy, and Progress Report

Specific Aims

Required (unless otherwise specified in FOA)

  • State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the research field(s) involved.
  • List succinctly the specific objectives of the research propose, e.g. 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 field, or develop new technology.
  • Limited to 1 page (unless otherwise specified in FOA)
  • Useful, outside resource: Northwestern Collaborative Learning and Integrated Mentoring in the Biosciences (CLIMB) video series on NIH grant proposals

Formatting Instructions

Research Strategy

  • Required Page Limit varies by Activity Code: R01 – 12 pages R03 – 6 pages R21 – 12 pages
  • Complete list available at https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-...
  • Organize the Research Strategy in the order specified below, and start each section with the appropriate heading – Significance, Innovation, Approach.
  • You may address the Significance, Innovation, and Approach either for each Specific Aim individually or for all of the Specific Aims collectively.
    • For new applications – include information on preliminary studies.
    • Discuss the PD/PI’s preliminary studies, data, or experience pertinent to this application. [R21/R33, R03, and R15 are typically the only exceptions.]
    • For renewal and revision applications – provide a Progress Report (as described below).
    • This is included in the page limit.

Significance

  • Explain the importance of the problem or critical barrier to progress that the proposed project addresses.
  • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
  • 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.

Innovation

  • 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 of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

Approach

  • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project.
  • Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project.
  • Describe the experimental design and methods proposed and how they will achieve robust and unbiased results.
    • Include how the data will be collected, analyzed, and interpreted, as well as any resource sharing plans as appropriate (unless addressed separately in the Resource Sharing Plan, which is typically required for submissions requesting >$500,000 in annual direct costs)
  • 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.
  • Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans.
    • For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex.
    • Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.
    • A full discussion on the use of select agents should appear in the Select Agent Research attachment below.
    • If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line from the NIH hESC Registry cannot be chosen, provide a strong justification for why an appropriate cell line cannot be chosen from the registry at this time.

Progress Report Publication List (if applicable)

Required only if the application is a renewal

  • List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively. Y
  • ou are allowed to cite interim research products.
    • Note: Interim research products have specific citation requirements.
    • Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each of the following:
      • Articles that fall under the Public Access Policy,
      • Articles that were authored or co-authored by the applicant and arose from NIH support,
      • Articles that were authored or co-authored by the applicant and arose from AHRQ funding provided after February 19, 2016 (see the Guide Notice on Policy for Public Access to AHRQ-Funded Scientific Publications).

 

Other Research Plan Section

This section contains: Vertebrate Animals, Select Agent Research, Multiple PD/PI Leadership Plan, Consortium/Contractual Agreements, Letters of Support, Resource Sharing Plan(s), and Authentication of Key Biological and/or Chemical Resources.

Vertebrate Animals

Required if you answered “yes” to R&R Other Project Information Form Question 2(?): Are Vertebrate Animals Used? Attach as PDF [link to formatting] Note: Do not use this attachment to circumvent the page limits of the Research Strategy

Formatting Instructions

Select Agent Research

Multiple PD/PI Leadership Plan

Consortium/Contractual Agreements

Letters of Support

Resource Sharing Plan(s)

Authentication of Key Biological and/or Chemical Resources

 

Appendix

 

 

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