Last Updated: February 14, 2018 NIH Checklist for due dates on or after January 25, 2018

[INSERT PROPOSED PROJECT TITLE]

National Institutes of Health Expanded General Checklist for Research (R) submissions

This document was created by the Tufts University Office of Research Development (ORD) to serve as a project management tool. It does NOT replace the detailed information available within the relevant funding opportunity announcement, the funding agency’s forms, instructions, and review criteria. For any questions, please refer to the funding opportunity announcement (FOA) or contact the program officer.

The completed application must be finalized and sent to Tufts Pre-Award no later than five business days before the NIH due date. See the full five-day rule policyfor all details.

Principal Investigator:
FOA in response to:
letter of Intent Due Date:
Internal Due Date:
Application Due Date:
Senior Personnel:
NIH Grant Application Guide /
Forms/Instructions for Research FOAs: / Research Forms E
ORA Contact:
Submission Type (new, resubmission, renewal):
NIH General Information
Page Limits /
Format Guidelines /
Tufts General Information
Tufts Forms, Tools, and Templates
Summaryof Narrative Components for NIH Research (R) Grants
Required unless FOA specifies otherwise
Project Summary/Abstract / No longer than 30 lines of text; not to exceed 1 page.
Project Narrative / 2-3 sentences.
Bibliography & References Cited / No page limit.
Facilities and Other Resources / No page limit.
Equipment / No page limit.
Biosketch / Limited to 5 pages.
Budget Justification / No page limit.
Specific Aims / 1 page unless otherwise noted in FOA.
Research Strategy / 12 pages for R01 unless FOA specifies differently. FOA supersedes.
If Applicable Narrative Components
Letter of Intent
Introduction (for resubmissions and revisions only)
Progress Report Publication List (for renewals only)
Vertebrate Animals
Select Agent Research
Multiple PD/PI Leadership Plan
Consortium/Contractual Arrangements
Letters of Support
Data Sharing Plan, Sharing Model Organisms, and Genome-Wide Association Studies
Authentication of Key Biological and/or Chemical Resources
Appendix
Human Subject and Clinical Trials Information
Components of Proposal / Elements to Complete / Description
(including Research Forms E section number, e.g., R.100) / Person Responsible
Letter of Intent / If applicable / Submit a letter of intent that includes the following information:
  • Descriptive title of proposed activity.
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s).
  • Names of other key personnel.
  • Participating institution(s).
  • Number and title of this funding opportunity.
  • See FOA for more details and the addressee.

SF 424 (R&R) Form:
Cover Letter / Required –
Data Entry and Attachment /
  • Data entry; complete entire form; section R.200.
  • Cover Letter: encouraged; FOA may require; section R.200.21.

PHS 398 Cover Page Supplement Form / Required –
Data Entry /
  • Includes yes/no answers to Vertebrate Animals, Program Income, Use of Human Embryonic Stem Cells, Inventions and Patents, Change of Investigator/Institution.
  • Section R.210.

R&R Other Project Information Form / Required –
Data Entry and Attachments /
  • Answer yes/no to all.
  • Complete sections as needed: Human Subjects, Vertebrate Animals, Proprietary Information, Environmental Questions, Historic Place, International Collaborators.
  • Attach Project Summary/Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, Equipment, Other Attachments (see below for details).
  • Section R.220.

Project Summary / Abstract / Required –
No longer than 30 lines of text /
  • A concise description of the proposed work for dissemination to the public and able to stand on its own, separate from the application.
  • State objectives and specific aims, making reference to the health relatedness of the project.
  • Describe the research design and methods.
  • Avoid descriptions of past accomplishments
and first person.
  • Do not include proprietary, confidential information, or trade secrets.
  • Section R.220.7.

Project Narrative / Required –
2-3 sentences /
  • Describe project’s relation to public health; for dissemination to the public.
  • Section R.220.8.

Bibliography & References Cited / Required unless FOA specifies otherwise /
  • List any references cited in the Research Plan.
  • No page limit.
  • Section R.220.9.

Facilities and Other Resources / Required unless FOA specifies otherwise /
  • Facilities include Laboratory, Animal, Computer, Office, and Clinical & Other. If appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project.
  • Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport).
  • Describe resources that directly apply to the proposed work.
  • Section R.220.10.
  • Template available.

Equipment / Required /
  • List major items of equipment already available for this project and, if appropriate, identify location and pertinent capabilities. Section R.220.11.
  • Template available.

Project/Performance Site Location(s) Form / Required –
Data Entry /
  • Primary site should be that of the applicant organization or identified as off-site in accordance with the organization’s F&A agreement.List all project sites.
  • Section R.230.

R&R Senior/Key Person Profile (Expanded) Form / Required –
Data Entry /
  • For each PI and Senior/Key Person.
  • Section R.240.

Required –
Biographical Sketch /
  • For all senior/key personnel and other significant contributors.
  • Includes a personal statement section.
  • Limited to 4 publications or research products.
  • Limited to 5 pages per PI/key person unless otherwise noted. Section R.240.
  • Biosketch Template and Sample.

If applicable –Current and Pending Support /
  • Only required if requested in the FOA; this attachment is usually requested later during the submission process.
  • Section R.240.

Budget Forms
(includes Budget, Budget Justification, and Subaward Budget) / Required –Budget –
Data Entry /
  • For budgets over $250K/yr (excluding F&A) use R&R Detailed Budget Form; Section R.300.
  • For budgets $250K/yr or less (excluding F&A costs), use PHS 398 Modular Budget Form; Section R.320.

Required –Budget Justification /
  • For Detailed Budget, see Section R.300.L.
  • For Modular Budget, see Section R.320.2.

If applicable –Subaward Budget /
  • For Detailed Budget, see Section R.310.
  • Modular Budgets do not require a separate subaward budget; see Section R.320.

PHS 398 Research Plan Form / Required /
  • Includes fields to upload attachments listed
below.
  • Attachments should not duplicate information collected in new Human Subjects and Clinical Trials info sheet.
  • See Section R.400.

Introduction / Resubmissions or revisions only /
  • Limited to 1 page unless FOA specifies otherwise.
  • See Section R.400.1.

Research Plan Section:
Specific Aims / Required unless FOA specifies otherwise /
  • Limited to 1 page unless FOA specifies otherwise.
  • See Section R.400.2.
  • R01 Specific Aims Guidelines available.

Research Plan Section:
Research Strategy / Required /
  • Discuss the overall strategy, methodology, and analyses of the proposed research.
  • Do not duplicate information collected in new Human Subjects and Clinical Trials info sheet.
  • See FOA for page limit and specific instructions. R01 is 12 pages unless FOA specifies otherwise.
  • See Section R.400.3 for required sections.

Research Plan Section: Progress Report Publication List / Renewals only /
  • See Section R.400.4.

Vertebrate Animals / If applicable /
  • See Section R.400.5.

Select Agent Research / If applicable /
  • See Section R.400.6.

Multiple PD/PI Leadership Plan / If applicable /
  • See Section R.400.7.
  • Template available

Consortium/Contractual Arrangements / If applicable /
  • Explainthe programmatic, fiscal, or administrative arrangements between the applicant organization and other participating organizations.
  • See Section R.400.8.

Letters of Support / If applicable /
  • Stipulate expectations for co-authorship, and whether cell lines, samples or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only.
  • Do not place letters in the Appendix.
  • See Section R.400.9.

Resource Sharing Plan(s):
See Section R.400.10 / Data Sharing Plan
(if applicable) /
  • Required for any proposal requesting direct costs of $500,000 or more in any year and by some other FOAs.
  • 1-paragraph description of how data will be shared or why sharing is not possible.
  • You may find the TuftsDMP Toolhelpful. Library staff members with expertise in data management are available to assist. Please see the Library Research Guide and contact Martha Kelehan (Medford/Grafton) or Rebecca Morin (Boston) for assistance.

Sharing Model Organisms /
  • If applicable.

Genome-Wide Association Studies /
  • If applicable.

Authentication of Key Biological and/or Chemical Resources / If applicable /
  • Describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies.
  • No more than one page is suggested.
  • See Section R.400.11.

Appendix / If applicable /
  • Do not use the Appendix to circumvent page limits.
  • Specific FOA instructions supersede general instructions in Section R.400.12.
  • Note policy changeeliminating clinical trial-related materials and change eliminating most appendix material.

Human Subjects and Clinical Trials Information / If applicable /
  • Read all the instructions in the FOA before completing this form to ensure your application meets all IC-specific criteria.
  • Make sure your FOA accepts clinical trials.
  • See Section R.500 and New Form link for instructions.

PHS Assignment Request Form / Optional /
  • May be used tocommunicate specific assignment and review requests, see Section R.600.

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Source: Office of Research Development (ORD), Tufts University