NIH R01 Checklist for Investigators
(reviewed & updated 10/17)

The following checklist is designed to assist you in preparing a standard NIH R01 application, and for the most part it may also be used with other grant mechanisms (e.g. R21, R03, etc.).

A signed institutional Routing Form is required with all applications prior to submission.  Refer to the Application Review Requirements for additional and special guidelines or contact your Sponsored Programs Officer for help.

Component   Description
Funding Opportunity Announcement (FOA)

Identify the FOA you are responding to
Make sure program and application guidelines are met
Format Specifications   Use permitted fonts (type & size); see SF424 Application Guide for details
    Use NIH form pages when available (i.e. Biosketch, Facilities & Resources, Targeted/Planned Enrollment Table)
    Observe page limitations and margin specifications (A minimum 0.5 inch margin required on all 4 sides.) 
Application Title   Limited to 200 characters including the spaces between words and punctuation; excess characters will be truncated
eRA Commons Username   Include username for the Principal Investigator (PI) in biosketch; contact your OSPA Sponsored Programs Officer to request a new account
Institutional Human Subjects Assurance #   Assurance # is auto-filled for InfoEd submissions when response to use of human subjects is YES. 
Institutional Animal Welfare Assurance #   Assurance # is auto-filled for InfoEd submissions when response to use of vertebrate animals (including use of custom antibodies) is YES.
Human Embryonic   Include the registration # of the cell line from the NIH registry
Stem Cells   Obtain ESCRO approval prior to award
Multi-PI   Involves more than one Principal Investigator (PI)
    Include Multiple PI Leadership Plan in the Research Plan
    See NIH Multiple PI for more information
Key Personnel   Identify under Key Personnel section
    Require measurable effort commitment (› zero)
    Provide biosketch for each person identified as a Key Personnel or Other Significant Contributor
Personnel with zero (NO) effort must be listed as Other Significant Contributors (under Key Personnel).
Budget & Justification   Follow format for either Modular (annual direct ≤ $250,000) or Non-modular (annual direct > $250,000) budget
    Verify requested years and costs complies with grant mechanism
    Obtain prior approval from NIH Program Official six weeks or longer (depending on specific program/IC requirements) in advance if direct costs > $500,000 in any year; 
    Modular Budgets: list all personnel involved in the research; include effort to be committed and brief description of each person's responsibilities
    Non-Modular Budgets: justify all items requested in the budget with an explanation; list all personnel involved, their proposed effort commitment and brief description of his/her responsibilities
Resources   Describe how the scientific environment in which the research will be done contributes to the probability of success (eg. institutional support, physical resources, and intellectual rapport)
    Early Stage Investigators should describe institutional investment in the success of the investigator (eg. resources for classes, travel, training; collegial support such as career enrichment programs, more...)
    Demonstrate adequate resources, facilities, and equipment available to carry out the research; describe any special facilities used for working with biohazards or other potentially dangerous subtances
    Refer to resources/facilities boilerplates
Other Attachments   Briefly describe methods used to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. for application due on or after 1/25/16. See NOT-OD-16-011.
Research Strategy   Must comply with page limitations for the Specific Aims and Research Strategy
    Address additional sections listed below, if applicable
Introduction   Required for resubmissions and revisions. For resubmissions, address major summary statement concerns; for revisions, describe the nature of hte supplement and how it will influence the specific aims, research design, and methods of the current grant.
Human Subjects   Complete all human subjects sections of application (Protection of Human Subjects, Inclusion of Women & Minorities, complete Targeted/Planned Enrollment Table, Inclusion of Children)
    Contact IRB Chair to determine if review/approval is needed
    Refer to 'Signing Off on Application with Human Subjects' for institutional compliance
Vertebrate Animals   Complete vertebrate animal section of application
See OLAW Vertebrate Animal Section Fact Sheet for guidance
    Refer to 'Signing Off on Application with Animal Subjects' for institutional compliance
rDNA   Consult with Lab Safety regarding any required approvals (e.g. Recombinant DNA Advisory Committee)
Select Agents   Contact Lab Safety for any required approvals (CDC/USDA)
    Describe any special facilities used for working with biohazards or other potentially dangerous substances in the Resources section
    Refer to HHS and USDA Select Agents and Toxins for listing of Select Agents
Consortium/Contractual Arrangements
   Describe arrangement with investigators at other institutions; include their roles and name of their institution
Letters of Support   Include letters from all Consultants & Collaborators; should cite willingness to support PI
Data Sharing   Required for all proposals with direct costs >$500,000 in any year
    Refer to Data Sharing Plan boilerplate
Model Organism Sharing   Required for research involving development of unique model organisms
Plan   Refer to Model Organism Sharing Plan boilerplate
Genomic Data Sharing Plan   Required for applicants seeking funding for research that generates large-scale human or non-human genomic data
    See Genomic Data Sharing Guidelines
Bibliography/
Literature Cited		   Use correct format for citations, include names of all authors, name of book/journal, volume number, page numbers and year of publication
    Comply with NIH Public Access Policy
Appendix   Comply with NIH policy for appendix materials (e.g. most appendix materials are not allowed as of 1/25/17)
Resubmissions   Follow with NIH resubmission policy
Cover Letter   Include any of the following and reference the title of the Funding Opportunity Announcement and the Application Title:
    Reference authorization of relevant Scientific Review Officer (SRO) for late submissions.
    When intending to submit a video as part of the application, the cover letter must inlcude information about the intent to submit; see NOT-OD-12-141.
    Include a statement if the proposed studies will generate large-scale human or non-human genomic data, as detailed in the NIH Genomic Data Sharing Policy (NOT-OD-14-11 and NOT-OD-15-027).
   
Reference authorization by NIH Program Official to accept proposal with direct costs > $500,000 in any year
If eligible for Continuous Submission, information on the NIH committee service (e.g. study section, Advisory Council) and period of service should be provided
PHS Assignment Request Form (optional)  
Request NIH Institute/Center (IC) and study section with appropriate expertise to review your proposal for new submissions only (NOTE: it is very difficult to change study section panels for resubmissions). Can also include list of individuals who should not review your application, and identify scientific areas of expertise needed to review your application.
Just-in-Time (JIT)   Refers to the NIH request of additional information after the initial peer review of a proposal that is within possible funding range. Refer to NIAID JIT Questions and Answers for additional information.

Other Useful Links
NIAID Prepare Your Application
NIAID Sample Applications and Summary Statements

 


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