NIH Proposal Specifics

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Starting your NIH/grants.gov Proposal

Proposal preparation and process in brief

  • Starting point:
    To submit a proposal to the National Institutes of Health (NIH), both the individual and institution need to complete some registrations. Carleton College has already done the required registrations with Grants.gov and eRA Commons, but each individual principal investigator (PI) must have an account in the NIH online portal of eRA Commons before submitting a proposal. If you don't yet have an eRA Commons account, call Corporate and Foundation Relations (CFR) (507-222-4441 or 507-222-4046) for assistance.
  • Proposal preparation via an application package
    • After the Principal Investigator (PI) confers with their program officer at NIH to determine the best program solicitation (PIs from liberal arts colleges often apply to NIH R15 AREA program, but also R01 or R03 and others; see this NIH Plan Your Application page), CFR staff Go to Grants.gov to create a Workspace to complete the forms online (utilizing NIH's Forms Version D applicable for proposals with due dates on or after May 25, 2016 through January 24, 2018; after January 25, 2018 Forms Version E are required), and populate forms with standard college information; or NIH's newer ASSIST (online system for the preparation, submission and tracking of grant applications through Grants.gov to NIH)   can be used; refer to the ASSIST User Guide.
    • Application can be worked on together via Workspace or a dropbox shared space, or individual pieces for the proposal can be sent to CFR staff who will input them into the online portal. We refer to the guidelines offered in both the application guide AND the specific Funding Opportunity Announcement (FOA). Note that the FAO instructions supersede application guide instructions.
  • Submission:
    • The SF424 (R&R) proposal application is submitted via grants.gov by designated Authorized Organization Representatives (AOR): Carleton's AORs are the Dean of the College and CFR personnel.
    • The NIH retrieves the application from grants.gov and processes it in their eRA Commons online portal, assembling the submitted forms and PDF attachments into a cohesive application.
  • Viewing:
    We (PI and CFR staff) login to eRA Commons to see if any “errors” or “warning” notices are identified for your submission. An application must be error-free to complete the electronic submission process. There is a 2-day viewing opportunity before the application moves on to the review process.

    A few formatting particulars

    (from SF 424_RR_Guide Forms-D "Format Attachments")

    Font: For applications submitted for due dates on or after January 25, 2017, the following fonts are recommended for text in PDF attachments

    - Arial, Georgia, Helvetica, Palatino Linotype. Other fonts are acceptable if they meet the requirements below.

    • Font size: must be 11 points or larger (excepting figures, graphs, diagrams and charts).
    • Type density: must be no more than 15 characters per linear inch (including characters and spaces).
    • Line spacing: must be no more than six lines per vertical inch.
    • Text Color: No restriction (though black or other high-contrast text colors are recommended to be used within grant applications attachments).

    PDF File names are 50 characters or less (including spaces); can use one space (not two or more) between words; avoid use of "&"/ampersand. Note: all attachments must be in pdf format.

    Margins need to be at least 1/2 inch (top, bottom, left, right) for all pages. NO information should appear in the margins (nothing in the header or footer), including PI name or page numbers. Pagination is system-generated.

    Hyperlinks and URLs are only allowed when specifically noted in funding opportunity announcement and form field instructions (e.g., biosketches, publication lists), and when allowed, hyperlink the actual URL text rather than hiding the URL behind a specific word or phrase; reviewers are not obligated to view linked sites.

     Helpful Information and Links

    • In a post to the NIH’s “Open Mike” blog, Dr. Michael Lauer, the Deputy Director for Extramural Research, summarized a massive analysis of 123,000 different applications to the flagship R01 program that sought to correlate peer reviewers’ score of various application components (significance, investigator(s), innovation, approach, and environment) with whether the application received funding. In brief, the analysis

      found that by far an application’s approach score, and to a lesser extent, the significance score, were the most important predictors of overall impact score and of whether any given application is funded. What does this mean for you as applicants? We think it’s helpful for R01 applicants to know that the description of the experimental approach is the most important predictor of funding, followed by the significance of the study.

    • Scan NIH's Grants Process Overview
    • Refer to NIH's Application Guide
    • Listen to informative podcasts at NIH's “All About Grants” (transcripts available also)
    • Read all about specific guidelines in the Forms Version D General (G) Instructions for the SF424 (R&R) for applications with due dates through 1/24/18. Use Forms Version E (NIH Notice NOT-OD-17-119 lists some changes from Forms Version D, as does G.120-Significant Changes of the application guide) for applications due on or after January 25, 2018.

    Components of an NIH proposal

    Mandatory forms for many NIH proposals, with commonly used attachments (in bold italics)

    • PHS 398 Cover Page Supplement
      An additional form where we identify such aspects as vertebrate animal practices, program income information, or inventions and patents. Details are here.
    • R&R Other Project Information
      • Project Summary/Abstract: no more than 30 lines of text; give a succinct and accurate description of the proposed work that states broad objectives and specific aims with reference to the health relatedness of project.
      • Project Narrative: no more than 2-3 sentences; describe relevance to public health.
      • Bibliography & References Cited: no page limitation; provide bibliographic citations based on the Research Plan, including names of all authors; note Public Access (NIH supported pubs) citation requirements.
      • Facilities and Other Resources: no page limitation; describe resources available, and address specific program requirements (i.e., R15/AREA applications ask for specifics such as a profile of students, description of how the scientific environment will contribute to the probability of success of the project, how the project will benefit from unique features of the environment; must include a plan for how RCR training will be conducted; Early Stage Investigators need to explain the institutional investment in the success of the investigator, e.g., resources, classes, etc.).
      • Equipment: no page limitation; list major items of equipment already available for the project.
    • R&R Senior/Key Person Profile
      • Biographical Sketch(es): maximum of 5 pages, required for each individual identified as key personnel; provide text for sections of Personal Statement, Positions and Honors, Contribution to Science, Research Support; newer format requirements allow for 5 pages rather than 4, and require inclusion of narrative text rather than merely a list of publications in the Contributions to Science section; see more below in Significant or Recent Changes including a link to this notice with biosketch instructions for Forms D. Find the Biographical Sketch Format Page here-MS WORD, instructions-MS WORD, a sample-MS WORD, and this link to a resource– Build it using SciENcv.
    • PHS 398 Research Plan
      Pieces most often needed for this form are listed below. Additional attachments may include Letters of Support, Vertebrate Animals, Multiple PD/PI Leadership Plan, or sections for human subjects. Refer to the Research Plan Section of the Forms Version D General (G) Instructions for the SF424 (R&R), or page R-75 of the specific Research Instructions pdf. See "Optional Pieces" below for more on vertebrate animals.
      • Specific Aims: 1 page; address research goals, expected outcomes, impacts; see Research Plan Section or p. R-75 in the Research Instructions pdf. NIH personnel state that the abstract and specific aims pages are "most read so make sure these are strong, clear, significant, and compelling" and they suggest that PIs get feedback on this 1-page Specific Aims.
      • Research Strategy: limited to 12 pages for R15/AREA, 15 pages for RO1s; describe the project, addressing specific sections of Significance, Innovation, Approach; see "3. Research Strategy" or Research Instructions pdf p. R-75.
        • The NIH's "Rigor and Reproducibility" chart provides an excellent guide to how and where in the Research Strategy document an applicant should address four key "areas of focus" in her application:
          • Scientific Premise - "Significance" section
          • Scientific Rigor (Design) - "Approach" section
            • Note that NIH research shows that the quality of this section is the most important predictor of whether a given application receives funding.
          • Biological Variables - "Approach" section
          • Authentication - As a separate attachment, not in the Research Strategy.
      • Resource Sharing Plan: 1 paragraph; data sharing applies to applications with direct costs of $500,000 or greater in any single year (so not often applicable to us); may also possibly need to address Sharing Model Organisms or Genomic Data Sharing; see these supplemental instructions. In addition, applicants can obtain more general advice on resource sharing on the CFR Dissemination and Sharing of Research Results page.

    Optional pieces

    Budget: a budget is ALWAYS REQUIRED, but NIH includes the budget forms under the subheading "Optional" on the application package front page; applicants are asked to choose from either a modular budget or a detailed Research & Related (R&R) Budget; learn of the distinctions between the two types below in the budget section.

    Round the budget numbers: “While the dollar fields allow cents to be entered, all dollar fields should be presented in whole numbers. Please round to the nearest whole number.”

    Cover Letter Attachment: though optional, a cover letter is encouraged to indicate disciplines involved if your project is multidisciplinary, and to provide explanations for a late application or subaward budget component or other unusual situations.

    PHS Assignment Request Form: an optional form - new for the May 25, 2016 proposals due date - that includes information previously collected in the "Cover Letter Attachment," gives the PI an opportunity to indicate: funding component assignment preference, Study Section Assignment(s) Request, individuals who should not review your application due to conflicts, and specific types of expertise needed to review your application.

    If Vertebrate Animals are involved: as a part of the Research Plan Form, address the 5 points identified in the Vertebrate Animal section (no page limit) [for additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf]; on the R&R Other Project Information Form, Vertebrate Animals form say "Yes" to "Is the IACUC review Pending?" even if the review/approval process has not yet begun. Call CFR (x4441) for Carleton's Animal Welfare Assurance number.

    Some changes to the Vertebrate Animal section for applications submitted for due dates on or after January 25, 2016 (see NOT-OD-16-006):

    • A description of veterinary care is no longer required.
    • Justification for the number of animals has been eliminated.
    • A description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines.

    For more:

    Multiple Investigators or Consortiums

    Collaborative proposals are those in which investigators from two or more organizations wish to collaborate on a unified research project. If your project involves multiple investigators, talk with CFR as there are special considerations in form completion and budgeting calculations (examples: a Multiple PI/PD Plan is to be included within the Research Plan Section; if there are consortium/contractual activities they are to be described and attached per guidelines PHS 398 Research Plan, Consortium/Contractual Arrangements; if a subaward is proposed, instructions for preparing the budget form are at R&R Subaward Attachment(s) Form.


    Significant or Recent Changes

    UPCOMING -New FORMS-E will apply for due dates on or after January 25, 2018. For more read NOT-OD-17-062

    A December 2016 release of NIH's application guide simplifies the presentation of the application instructions. Recent changes continue to be summarized in the Significant Changes section of the application instructions.

    For applications due on or after January 25, 2017, NIH updated its recommended font list and no longer requires that black text be used within grant application attachments. Read more in the NIH Guide (NOT-OD-17-030NIH Guide.

    The changes mentioned below are current and result in part to newer federal OMB "Uniform Guidance" rules effective 12/26/14, but most recently and significantly (late March 2016) from NIH upgrading to Forms Version D.

    Significant Changes with Forms Version D

    This G.120 - Significant Changes page covers application Guide Restructure, SF424 Research and Related (R&R) Form Changes, and Form D Changes.

    Changes, outlined in NOT-OD-016-081, focus on the areas of: Rigor and transparency in research, Vertebrate animals, Inclusion reporting, Data Safety monitoring plans, Research training, Appendices, Font requirements, New PHS assignment request form and revised guidance for cover letter attachments, Biosketch clarifications.

    Some specifics are highlighted below.

    Biographical Sketch

    For Forms Version D specifically, this notice gives clarification and consolidated biosketch instructions for application with due dates on or after May 25, 2016.

    Clarified instructions (changes)--

    • Indicate that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography.
    • Allow publications (peer-reviewed and non-peer-reviewed) and research products to be cited in both the personal statement and the contributions to science sections
    • State that graphics, figures, and tables are not allowed.
    • Remove the requirement that the past 3 years of research support are listed in order of relevance.
    • Give option to add other names used to author research products in section A.
    • Allow research products to include conference proceedings such as meeting abstracts, posters, or other presentations.
    • Allow research products that are under development, such as manuscripts that have not yet been accepted for publication, to be mentioned in the narrative sections; however, they cannot be cited as one of their citations.

    Newer required formatting that began in 2014:

    The biographical sketch can be a maximum of 5 pages (an increase from 4 to 5 pages), and needs to include experience in supervising students in research in the Personal Statement, and identification of which publications involved students (per PA-16-200, also see Instructions for a Biographical Sketch). The newer format has four sections:

    • A: Personal Statement - new: a description of why you are well-suited for your role in the project, a listing of publications that highlight your qualification, and impediments to past productivity
    • B: Positions and Honors - same as before; provide a chronological list of positions and honors
    • C: Contribution to Science - was previously named "Peer-reviewed publications"; new: this section now calls for some narrative on significant contributions to science with reference to publications, and URL to full list of published work
    • D: Research Support - only change is the wording "for the past three years" when listing ongoing and completed research projects

    Research Plan

    Forms-D Changes in the Research Plan (for proposals due on or after May 25, 2016)

    • New "Data Safety Monitoring Plan" attachment (for clinical trials, so rarely applicable to us)
    • New "Authentication of Key Biological and/or Chemical Resources" attachment
    • Minor format and label changes
    • Added/updated burden statement and form expiration date
    • Updated form instructions

    Budget and Budget Justification

    Forms-D Changes in the budget (for proposals due on or after May 25, 2016) are so small as to hardly be noticed: for the Modular Budget there are minor label changes and form instructions, and Indirect Costs section now dynamically adds indirect costs (rather than static fields).

    Changes resulting from "Uniform Guidance" rules effective 12/26/14:

    • "Equipment" (Section C on the R&R Budget Form) is still defined as tangible property with a per-unit acquisition cost of $5,000 or above, but rules addressing procurement have changed. When intending to purchase any item with a cost of over $3,000, complete the Vendor Selection Form.
    • If your project includes a subaward, contact CFR and the Business Office for assistance with specific requirements for pass-through entities (the College, acting as fiscal agent) around monitoring and forms or documents needed. For example, we must document the determination of subrecipient versus contractor using this form.
    • Administrative programmatic costs can be included in the budget as direct costs if 1) administrative or clerical services are integral to a project or activity, 2) individual/s can be specifically identified with the project or activity, 3) such costs are explicitly included in the budget or have the prior written approval of the agency (see CFR staff for example of a justification statement to use for "prior written approval"), and 4) the costs are not also recovered as indirect costs.
    • Read more immediately below in the "About Budgets" section.

    If Vertebrate Animals are involved

    Some changes for applications submitted for due dates on or after January 25, 2016 (see NOT-OD-16-006):

    • A description of veterinary care is no longer required.
    • Justification for the number of animals has been eliminated.
    • A description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines.

    Other changes

    Title: On a much smaller scale, the title can now be 200 characters (with spaces) rather than the previous 81 character limit.

    PDF file names: pdf file names can use a space to separate words rather than underscore.

    New for May 25, 2016

    • New, optional "PHS Assignment Request Form" that complements existing "Cover Letter Attachment" on SF424 (R&R) form and gives PI opportunity to indicate: funding component assignment preference, individuals who should not review your application due to conflicts, and scientific areas of expertise needed to review your application.
    • PHS 398 Cover Page Supplement Form changes include a new Vertebrate Animals section, removal of the "Disclosure Permission Statement" question, and other small changes or updates.

    About Budgets

    BUDGET & BUDGET JUSTIFICATION

    NIH uses two types of budgets.

     1) The MODULAR budget is used if direct costs are $250,000 or less (and all requested under Period 1 if submitting an R15/AREA proposal).

    Refer to the Cumulative Budget Information section, Modular Budget Justifications (of Personnel Justification, Consortium Justification, or Additional Narrative Justification). No page limitations.

     2) Use the RESEARCH & RELATED (R&R) budget if asking for $250,001 or more in direct costs. (Again, if submitting to R15/AREA, the total budget for all years of the proposed project must be requested in Budget Period 1.) Use R&R Budget item K attachment for budget justification -address both Personnel Justification & student involvement. No page limitations.

    Include a Budget Justification for an R&R budget to provide additional information requested in each budget category identified. Items and amounts need to be considered necessary, reasonable, allocable, and allowable.

    There are specific requirements for R15/AREA submissions (discussion of student involvement, how numbers are inputted). Talk with CFR and refer to the AREA program announcement PA-16-200.

    To access a budget template spreadsheet for internal use, go to Business Office Forms page, and under the heading "Government & Foundation Grant Forms" open "Research Grant Proposed Budget Template."

    For current figures to use in budget preparation - such as Carleton College faculty and student compensation guidelines, benefit percentages, indirect cost rate, and more - contact CFR (Dee 507-222-4441, Charlotte 507-222-4046, or Christopher 507-222-5833).

    INDIRECT COST is a line item in nearly every proposal budget submitted to a federal agency. In contrast to straightforward project expenses of "direct costs" (such as salary, benefits, equipment, travel, supplies), indirect costs (also referred to as F&A {Facilities & Administrative Costs}) are "those costs which are not readily identifiable with a particular cost objective but nevertheless are necessary to the general operation of an organization."

    An Indirect Cost Rate (IDC) agreement is negotiated with a Federal agency every four years. Carleton's IDC rate agreement, negotiated with DHHS based on our Audited Financial Statements for the period ending June 30, 2014, has been approved at a rate of

     58% for federal grants awarded on July 1, 2017 through June 30, 2019.

     The Business Office government grant proposal page explains that the rate is "calculated on the total of all faculty or technician salaries/stipends and undergraduate student stipends."

    The indirect cost rate in effect at the time of the initial awarding of a grant is in effect throughout the life of the grant.

    EFFORT is recorded in any budget, and expressed in person months; see the FAQ (below) "What are person months and how do I calculate them?"


    Tips for AREA proposals

    Program officers for NIH's AREA (Academic Research Enhancement Award) program (PA-16-200) offer these tips for successful proposals:

    A key criterion for AREA projects is how the grant will improve the "research environment" at the institution, primarily by expanding programmatic or administrative capacities related to research. Too many proposals neglect this criterion.

    AREA grants can include, or subsequently seek, "diversity supplements" to support outreach from the institution to K-12 students, or even undergrad/grad students at other institutions. These awards are purported to be easy to request and obtain - especially if the supplement is used to continue to employ students from underrepresented groups as researchers in the second half of the grant period.

    The biosketch should dovetail well with the "Facilities and Other Resources" document on the institution itself - e.g., internal grant awards listed in the biosketch should be described in the resource area as faculty-development programs. 

    The scientific aims are best phrased as questions/hypotheses, not statements. These questions can then be recycled in grant reports, which will provide answers to the questions.

    PDs should use a graphic (timeline/table/chart) to lay out their aims and match those aims to the resources - especially the personnel, including the PD and undergrad researchers (for whom continuity across the project can be a question).


    Compliance specifics

    What do I need to do to be compliant with federal requirements?

    Each organization receiving funding from a federal agency needs to certify that the institution and individuals are following specified federal guidelines. Carleton asks all primary investigators (PI and coPIs) involved in a proposal to a federal governmental agency (NSF, NIH, NEH, etc.) to read and sign a Compliance & Disclosure Form. The form addresses college policies and provides a checklist with links addressing I) financial conflicts of interest, II) human or animal subject involvement, III) responsible conduct of research, and IV) environmental health and safety issues. 

    What is RCR and how do I comply?

    RCR stands for "responsible and ethical conduct of research." The submitting organization must certify that there is "a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project." NIH states that the "grant application must include a plan for how you will carry out instruction in responsible conduct of research." Guidelines don't specify, but CFR suggests this be included in the Facilities document. Go to the CFR page Responsible Conduct of Research to link to an online training course and to obtain more specific information. See NIH's Policy on Instruction in the Responsible Conduct of Research.


    FAQs

    How long is it until an award is made?

    The NIH Grants process can take approximately 10 months from application receipt and the peer review process through negotiation and award. The Grants Process At-A-Glance Chart on the Grants Process Overview page (look for the link to download a pdf just below the video box) is a resource for understanding the steps your application goes through in that time frame.

    Am I an early stage investigator?

    An individual who - is classified as a New Investigator (has not previously competed successfully as PD/PI for a substantial NIH independent research award), and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) - is considered an Early Stage Investigator (ESI). See also the definition of New Investigator (similar to early stage investigator but without the within-10-years-of-completing component) and New and Early Stage Investigator Policies.

    What are person months and how do I calculate them?

    What is the definition of "person-months"? "The term "person-months" refers to the effort (amount of time) that PI/coPI(s), faculty, and other senior personnel will devote to a specific project. The effort is based on the type of appointment of the individual with the organization: academic-year (AY), summer term (SM), or calendar-year (CY). For example, if the regular schedule is 10 months and 30% effort will be devoted to the project, a total of 3 months should be listed in the academic or calendar-year block (10 months x 30% = 3 months)." See other approaches below. How do I calculate the person-months per year committed to the project? "Multiply the percentage of your effort associated with the project times the number of months of your appointment (i.e., 10% of a 9 month AY appointment equals 0.9 person months; 10% of a 12 month calendar appointment equals 1.2 months)... Person months shown in the current and pending support section should usually equal the number of months on the NSF proposal budget." OR, if you know the number of hours, days, or weeks to be devoted to the project, person-months can be obtained by calculating the portion. For example, working 5 days on a project = 1 week/4 total weeks in a month = 0.25 person-months. Since a month includes a working day or two more than four weeks, an alternate way to calculate would be 5 days/22 work days in a month = 0.23 person-months. Simply said

    • Using weeks: multiply number of weeks by 0.23 to get person months (3 weeks x 0.23 = 0.69 person months). OR
    • Using days: multiply number of days by 0.05 to get person months (4 days x 0.05 = 0.20 person months).

    If the time varies in each year, calculate yearly person months and then average them for the final number to report on the NSF Current and Pending form. If devoting a term to research, the academic year person months can be calculated using 1/3 of 9-month appointment = 3.0 academic months (1/3 for Carleton's trimester system). With the NIH guidelines are different from NSF for summer work: it is permissible to ask for up to 3.0 months with NIH. NIH's FAQ page on Person Months is here.

    What is a "Resource Sharing Plan"?

    NIH defines 3 types: Data Sharing Plan, Sharing Model Organisms, Genomic Data Sharing. Most often only the Data Sharing Plan applies to an undergraduate institution (though certainly there are exceptions). Data Sharing Plan: Specific funding opportunity announcements may require a plan regardless of ask amount, but if not specified, investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. See these supplemental instructions, PA-16-200, or refer to Data-Sharing Policy.