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COVID-19 Information for NIH with COVID-19 FAQs.

Note that though an applicant is not allowed to include contingency plans for problems resulting from the COVID-19 pandemic in an NIH research plan, investigators may address effects due to the pandemic on productivity in the personal statement of the biosketch. See NOT-OD-21-180.

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 (refer to NIH’s Investigators and Other Users page, and NIH eRA Password Policy). An individual working in Grants.gov Workspace must also be registered in Grants.gov (see NIH’s Grants.gov – User Registration).
    • If you don’t yet have an eRA Commons account, contact the Grants Office (507-222-4441 or 507-222-4046) for assistance. Your eRA user account begins with Grants Office personnel (with Signing Official permissions) who will create or edit an account for the individual. Note that Two-Factor Authentication is required, with Login.gov being the primary system to meet the authentication standards.
  • Proposal preparation via ASSIST or Grants.gov Workspace
    • 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).
    • NIH’s ASSIST portal is the preferred online system for the preparation, submission, and tracking of grant applications through Grants.gov to NIH. Refer to the Preparing Your Application Using ASSIST page (with helpful Getting Started: Video), the ASSIST User Guide, and ASSIST Online Help.
    • The Grants Office staff or the applicant can go to the ASSIST page and enter the Funding Opportunity Announcement (FOA) number, or to Grants.gov for Workspace, to initiate an application and complete the forms online (use FORMS-G application packages for due dates on or after January 25, 2022; Starting January 25, 2023, applicants must use updated application forms and instructions identified with “FORMS-H” (NOT-OD-22-195), populating forms with standard college information. Before January 25, 2033, refer to NIH “FORMS-G” General Application guide for Due Dates on or after January 25, 2022. On and after January 25, 2023, refer to Forms H How to Apply – Application Guide.
    • An application can be worked on together via ASSIST, the Grants.gov Workspace, or a local Dropbox shared space; or individual pieces for the proposal can be sent to the Grants Office 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 always supersede application guide instructions.
  • Submission
    • The SF424 (R&R) proposal application is submitted via grants.gov by designated Authorized Organization Representative (AOR): Carleton’s AORs are the Office of the Provost and the Grants Office 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
    • The PI and the Grants Office staff login to eRA Commons to see if any “Error” 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 NIH’s How to Apply-Application Guide page, “Format Attachments” under “Write Application”)

Fonts

The following typefaces 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
  • should 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 (do not include headers or footers), including PI name or page numbers, as 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)
  • 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; don’t use hyperlinks anywhere else in your application

Components of an NIH proposal

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

Optional pieces

Budget

A budget is ALWAYS REQUIRED, but NIH labels the budget forms as “Optional” in the application portal or package, due to applicants being asked to choose from either

Learn of the distinctions between the two types below in the About Budgets 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.”

NOTE: starting Jan 25, 2023, include a request of funds for data management and sharing activities (if applicable) with justification in separate section.

Cover Letter Attachment

Though optional, a cover letter is encouraged

  • to provide explanations for a late application or subaward budget component,
  • for inclusion of a video,
  • if planning to generate large-scale either human or nonhuman genomic data as part of the study,
  • if preapproval is required, or
  • for other unusual situations.

See Cover Letter Attachment. Note that this attachment must NOT be used to communicate application assignment preferences.

A resource for helping determine whether to include a cover letter and what to include is “Cover Letters and Their Appropriate Use” (MP3, Transcript).

PHS Assignment Request Form

an optional form – the PHS Assignment Request form (starting May 25, 2016) – that includes information previously collected in the “Cover Letter Attachment,” gives the PI an opportunity to indicate

  • awarding component assignment preference,
  • study section assignment(s) request,
  • individuals who should not review your application due to conflicts, and
  • specific areas of expertise needed to review your application.

For Vertebrate Animals

If vertebrate animals are involved: as a part of the Research Plan Form, address the criteria identified in the Vertebrate Animal section (no page limit)
For additional information, see this Worksheet for Applications Involving Animals.

If YES to Vertebrate Animals even if the review/approval process has not yet begun, say “Yes” to “Is the IACUC review Pending?”
Call the Grants Office (x4046) for Carleton’s Animal Welfare Assurance number.

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 the Grants Office as there are special considerations

Significant or Recent Changes

Upcoming

New Policy for Data Management and Sharing

Effective January 25, 2023: NOT-OD-21-013 outlines the NIH Policy for Data Management and Sharing (DMS) that replaces the 2003 NIH Data Sharing Policy, and NOT-OD-22-189 provides implementation updates. A key change in FORMS-H is support for the implementation of the 2023 NIH Data Management and Sharing Policy.

Note that a brief summary of the DMS Plan and a description of the requested Data Management and Sharing Costs must be included within the budget justification attachment.

Resources: join a 2-part webinar series titled A Conversation with NIH: Implementing the New Data Management and Sharing Policy (Aug 11, 2022 and Sept 22, 2022); visit the NIH Scientific Data Sharing website and subscribe for real-time updates on the latest  news, resources, and policy information.

See also: NIH Data Sharing Website, Data Management and Sharing Policy, Writing a Data Management & Sharing Plan – Applications for Receipt Dates ON/AFTER Jan 25 2023, Scientific Data Sharing FAQs

New FORMS-H

Starting January 25, 2023, applicants must use updated application forms and instructions identified with “FORMS-H” (NOT-OD-22-195). The primary change to the updated application forms is the addition of an “Other Plan(s)” attachment on the PHS 398 Research Plan as part of the implementation of the 2023 NIH Data Management and Sharing Policy (NOT-OD-22-189).

See also: High-level Summary of Form Changes in FORMS-H Application Packages; FORMS-H How to Apply – Application Guide; and Annotated Forms Sets.

Other Updates

Log in Authentication

Starting in 2022, eRA Commons and ASSIST users will be required to use two-factor (2FA) login authentication [Login.gov] for applications or Research Performance Progress Reports (RPPR). A phased approach will apply to everyone  — all scientific account holders should take action now, while administrative account holders will be required to move to two-factor authentication in mid-2022. Refer to Two-Factor Authentication: Accessing eRA Modules via login.gov.

Biographical Sketch

BIOSKETCH: This NOT-OD-21-073 notice gives clarification and consolidated biosketch instructions for applications and reports with due dates on or after May 25, 2021.

Changes include:

  • Section D. has been removed for non-fellowship biosketches. Information on ongoing and competed research projects from the past three years should be included in Section A.
  • Section B. now includes Scientific Appointments. All positions and scientific appointments, both domestic and foreign (including affiliations with foreign entities or governments), whether or not remuneration is received, should be listed in reverse chronological order.
  • Updated resources, including instructions, samples, FAQs, and more can be found at NIH’s Biosketch Format page.

R15/AREA changes

Starting in January 2019 and continuing, NIH administers two programs using the R15 activity code:

  • the Academic Research Enhancement Award (AREA) targeting undergraduate-focused institutions, that requires a letter of eligibility (see Sample Provost Letters Certifying Eligibility). AREA has two programs:
  • the Research Enhancement Award Program (REAP) targeting graduate schools of arts and sciences and health professional schools that grant baccalaureate or advanced degrees (PAR-19-134)

For more: check the NIH Research Enhancement Award (R15) webpage and FAQs – AREA and REAP (R15).

If Vertebrate Animals are involved

Some changes for applications submitted for due dates on or after January 25, 2016 and continuing (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 starting in 2016 and continuing

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.

Starting in May 25, 2016 and continuing

  • 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

MODULAR budget

1) A modular budget is used if direct costs are $250,000 or less per budget period (and all requested under Period 1 if submitting an R15/AREA proposal). A budget period is typically one year of support, though R15/AREA grants are an exception.

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

RESEARCH & RELATED (R&R) budget

2) If asking for $250,001 or more in direct costs, use a Research & Related (R&R) more detailed budget. (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.

Preparing your NIH budget

There are specific requirements for R15/AREA submissions (discussion of student involvement, how numbers are inputted). Talk with the Grants Office and refer to the R15/AREA (Academic Research Enhancement Award) for Undergraduate-Focused Institutions program announcement PAR-21-155.

To access a budget template spreadsheet for internal use, go to the the Grants Office Forms & Templates page.

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 the Grants Office (Dee 507-222-4441, Charlotte 507-222-4046, Quinn 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 4/22/19 based on our Audited Financial Statements, has been approved at a rate of

60% (of salaries and wages) for federal grants with award dates of July 1, 2019 through June 30, 2023.

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, clinical trial not allowed (PAR-21-155) offer these tips for successful proposals:

Be mindful of a key criterion

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.

Consider including a diversity supplement

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.

Dovetail biosketch info with the Facilities doc

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. 

Phrase scientific aims as hypotheses

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.

Use a graphic to match aims with resources/personnel

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).

Reflect on these pieces of advice from PUI PIs

  • Involve first years and sophomores, require a multi-semester commitment, and involve students in training new students
  • Given academic year fluctuations, consider a technician (part time or seasonal), duties for existing employees (teaching, lab maintenance), whether a shared tech for several labs/departments might be of benefit?
  • In the Research Strategy, address project feasibility with involvement of students
  • Teach experimental design in your lab classes
  • Consider cultural exposure to major research institutions
  • Assess what students need to participate (e.g., course credit, hourly pay, summer wages)

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 and Disclosure form (done via this Link to OnBase Form that requires OnBase login to access the form). The form addresses college policies and provides a checklist with links addressing I) financial conflicts of interest (FCOI), II) human or animal subject involvement, III) responsible conduct of research, and IV) environmental health and safety issues.

For FCOI, per the NIH Grants Policy Statement, institutions need to require investigators to complete the training prior to engaging in NIH-supported research and at least every four years, and when an investigator is new to an institution, or if an investigator is noncompliant with Carleton’s FCOI policy. Completing this NIH FCOI interactive training module satisfies the regulations.

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.”

Go to the the Grants Office page Responsible and Ethical Conduct of Research to link to CITI online training modules and to obtain more specific information on online RCR instruction.

See NIH’s Notice (NOT-OD-10-019) Update on the Requirement for Instruction in the Responsible Conduct of Research and Policy on Instruction in the Responsible Conduct of Research (pdf pg 337, specific to Career Development Grants).

FAQs

What is the definition of a clinical trial?

A clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

How do I determine which NIH Institute or Study Section is the best fit for my project?

  • Pre-submission:
    • Use NIH RePORTER‘s nifty Matchmaker tool (with helpful short tutorial) to find which NIH Institutes and Centers have funded similar projects and to access contact information for Program Officials (PO) or Program Directors (PD).
    • Contact the PO/PD of an NIH Institute that seems to most closely align with your research. The PO/PD, specific to a particular institute, manages a scientific research portfolio and can help you determine a fit (if not his/her institute, they can point you to a different one). Often the PO is willing to read a 1-page specific aims overview — it is recommended to contact the PO six months ahead of submission with the overview and your biosketch.
  • Post submission:
    • Shortly after submission, questions can be addressed to the Scientific Review Officer (SRO) who helps ensure that your project is fitted to the most appropriate Scientific Review study section. The SRO also recruits qualified reviewers, assigns applications to reviewers, and prepares summary statements for applications reviewed.

How long from submission until an award is made?

NIH Review Process image
NIH Review Process image

The NIH grants process can take approximately 10 months (but is often longer) from application receipt and the peer review process through negotiation and award.

What is the recommended structure for a Specific Aim?

It’s been said that the Specific Aims document is the single most important piece of your proposal. For each specific aim, the following structure is recommended:

  • Introductory paragraph
    • What is the research area? What is known? What is the gap in knowledge? What is the critical need? Who cares?
  • Second paragraph
    • What is the solution? What is the long-term goal and potential impact?
  • Aims
    • What will you do to test the hypothesis? What are the expected outcomes?
  • Final paragraph
    • Return to impact/payoff

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. More on Person Months on this NIH FAQ page.

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. For more, see Resource Sharing Plan(s).

Helpful Information and Links