NIH F31 Application Guide


NIH Predoctoral (F31) Application Guide 

 

 

Format Regulations for Attachments

Document format

PDF only; do not use headers or footers

Font type/size

*Recommended

Arial, Helvetica, Palatino Linotype, or Georgia typeface

11 or larger

Black

Line spacing

No more than 6 lines of type within a vertical space of 1 inch

Only single column formatting

Page size

 

8.5 x 11

0.5” margins on all sides

File Names

If you don’t follow the file name rules your application will be flagged with errors

File names cannot exceed 50 characters

Don’t use “&” sign

1 space in between words

Don’t start file name with a space

Citation Format

All citation formats are acceptable

Images (charts, etc.)

Only allowed in Research Strategy section

 

 

Table of Contents

eRA Commons Login……………………………………………………………………………………………………………..Page 2

Reference Letters………………………………………………………………………………………………………………….Page 2

R&R Cover Page…………………………………………………………………………………………………………………….Page 3

Requesting an Agency Assignment…………………………………………………………………………………..……Page 4

Other Project Information………………………………………………………………………………………………….....Page 5

Sites……………………………………………………………………………………………………………………………………….Page 6

Sr/Key Person Profile……………………………………………………………………………………………………………..Page 6

Fellowship Supplement………………………………………………………………………………………………………….Page 7

Budget Section……………………………………………………………………………………………………………………….Page 9

Human Subjects and Clinical Trails...………………………………………………………………………………………Page 9

 

The Graduate Division cannot assume responsibility for errors in the applicant’s submission.  We will do our best to review the format of your proposal; however final responsibility for format, content, and completeness rests with the applicant.

 

Before you begin your application:

  1. Connect with an appropriate business partner, usually your mentor’s fund manager, who handles contract and grant submissions.
  2. Apply through the correct central office:
    • If the applicant is a single-degree seeking student enrolled in a graduate program, either OCGA or SIO-OCGA will be submitting your application. However, if the student is enrolled in a professional degree program (i.e. PharmD, PharmD/PhD, or MD/PhD program), the applicant will need to contact Health Sciences Sponsored Project Pre-Award Office (HSSPPO).
  1. To apply for the NIH F31 fellowship you will use the ASSIST application portal via NIH eRA Commons.
    • Your eRA Commons Login should have the role of PD/PI assigned to your username, if you do not have the role of PD/PI assigned, follow the steps below.
    • Set up your eRA Commons Login.
      • If you do not have an eRA Commons login please fill out this online form and request that aPD/PI role be assigned.
  1. Search for the solicitation number PA-21-051 if you are applying for a Parent Fellowship and PA-21-052 if you are applying for a Diversity Fellowship.

 

 

Reference Letters

Reference letters are a separate component of this application and will be completed through the eRA Commons. Referees must submit reference letters through the eRA Commons by the application due date.

 

Selecting a Referee

 

Instructions to Provide to Referees

Provide your referees with the appropriate instructions. Include your name (as shown in your Commons account, your eRA username, and the number of the FOA)

Letters must be submitted directly to the eRA Commons. NIH provides Instructions for Fellowship Applicant Referees  that you may use as a template to share with your references.

 

You can learn more about letters of references at NIH’s Reference Letter website.

Campus Requirements

In order to submit a NIH F31 Application you will need a Kuali Research proposal record (typically completed by your mentor’s fund manager). The KR record should contain the following attachments: Solicitation, Internal Budget, signed NIH Fellowship Assurance Form, and a near-final draft of your ASSIST online application.

S F 4 2 4  P o r t i o n  ( F o r m  G )  o r   R & R   C o v e r   P a g e   ( A S S I S T )

1

Type of Submission

Check the box labeled “Application

2

Date Submitted

Enter date of agency deadline

Applicant Identifier

Last, First F31 KR [recordnumber]

3

Date Received by state

Leave Blank

State application Identifier

Leave Blank

4

a. Federal Identifier

Only for resubmissions, email for details

b. Agency Routing Identifier

Leave Blank

c. Previous Grants.gov Tracking ID

Leave Blank

5

Applicant Information

 

SAM Unique Entity ID (UEI)

UYTTZT6G9DT1

Legal Name

The Regents of the Univ. of Calif., U.C. San Diego

Department

Leave Blank

Division

Contact your Fund Manager for correct entry

Street 1

9500 Gilman Drive

Street 2

MC 0934

City

La Jolla

County/Parish

San Diego

State

California

Province

Leave blank

ZIP/Postal Code

92093-0934

 

Person to be contacted on matters involving this application

First Name

Michael

Last name

Kusiak

Position/Title

Director

Street 1

9500 Gilman Drive

Street 2

MC: 0934

City

La Jolla

County/Parish

San Diego

State

California

Province

Leave blank

Country

United States

zip/postal code

92093-0934

Phone

858-534-3330

Fax

858-534-0280

Email

researchadmin@ucsd.edu

6

Employer Identification (EIN) or (TIN)

1956006144A1

7

Type of Applicant

H: Public/State Controlled Institution of Higher Education

8

Type of Application

Check “New” if this is your first time submitting to NIH or first time submitting this project to NIH

 

 

Check “Resubmission” if you are submitting this application to NIH for the second time

 

Is this application being submitted to other agencies?

Answer yes or no and disclose which agency will also receive this proposal.

9

Name of Federal Agency

National Institutes of Health

10

Catalog of federal domestic assistance number

Leave blank

11

Descriptive Title of Applicant’s Project

Title of your project

12

Proposed Project Start Date

These are the earliest possible standard start dates for each cycle of NIH. If you are applying for :

 

 

Only request FULL years of support

 

Cycle 1 (April):

 

September or December

Cycle 2 (August):

April of next year

Cycle 3 (December):

July of next year

13

Congressional District of Applicant

CA-050

14

Project Director/PI Contact Information

This information is pre-populated from the Sr/Key Person tab.

To change this information, change it in the Sr/Key Person tab.

15

Estimated Project Funding

Please contact your Fund Manager

16

Is this application subject to review by the state executive order 12372?

Check “No” box: “This program is not covered by E.O. 12372”

17/18

Self-explanatory

 

19

Authorized Representative

For SIO, contact your Fund Manager for this information

 

Prefix

Ms.

First

Lisa

 

Last

Jandt Auvil

Position/Title

Senior Contract & Grant Officer

Name of Organization

The Regents of the Univ. of Calif., U.C. San Diego

Department

Office of Contract and Grant Administration

Division

Leave Blank

Street 1

9500 Gilman Drive

Street 2

MC 0934

City

La Jolla

County/Parish

San Diego

zip/postal code

92093-0934

Phone

 (858) 534-3330

Fax

 (858) 534-0280

Email

ljandtauvil@ucsd.edu

20

Pre-application

Pre-application materials are not needed for this application

21

Cover letter

Attach to number 21 of SF424 R&R page

 

Your request to be assigned to a certain agency DOES NOT go in this section*

Address letter to the Division of Receipt and Referral

Include application title

Include solicitation number (PA-21-052 Diversity, PA-21-051 Parent)

Include a list of referees (including name, departmental affiliation, and institution).

Statement that you have attached any required documentation for the type of application submitted.

If the proposed studies will generate large-scale human or non-human genomic data as detailed in the NIH Genomic Data Sharing Policy Include a statement in the cover letter

If the proposed studies involve human fetal tissue obtained from elective abortions (HFT), regardless of whether or not Human Subjects are involved and/or there are costs associated with the HFT include a statement in the cover letter. For further information on HFT policy refer to the NIH Grants Policy Statement, Section 2.3.7.11 Human Fetal Tissue from Elective Abortions, Section 4.1.14 Human Fetal Tissue Research and Section 4.1.14.2 Human Fetal Tissue from Elective Abortions.

 

*Requesting an Agency Assignment

If you would like your proposal to be assigned to a certain agency

  1. Go to the top left side of the screen
  2. Click on the tab that says “Actions”
  3. Select “add optional form”
  4. Select “Assignment Request”
  5. This form will be added as a tab to your ASSIST application next to the “fellowship supplement” tab.
  6. Fill out the form accordingly.

Other Project Information

1

Human Subjects

Not sure if your application requires human subjects approval? Click here for more information.

 

 

NIH’s 3 Exemptions Infographic

Finding the appropriate exemption number

If you will be using human subjects in your project and need to include a PHS Enrollment Inclusion Form, follow these instructions:

  1. Go to the top left side of the screen
  2. Click on the tab that says Actions
  3. Select “add optional form”
  4. Select “PHS Enrollment Inclusion Form”
  5. This form will be added as a tab to your ASSIST application next to the “fellowship supplement” tab or “assignment request” tab

1a

IRB approval

IRB approval date is NOT required at time of submission

 

More information about IRB here, page F-32

If IRB is pending, leave blank

2

Vertebrate Animals

If animal involvement is anticipated within the period of award but plans are indefinite, check "Yes."

 

 

If yes, complete the vertebrate animals attachment (for more information, refer to “Are Vertebrate Animals Used?” in the  NIH Guide)

2a

IACUC

If IACUC approval is pending, leave blank. Approval dates must be within 3 years.

 

 

IACUC approval date is NOT required at the time of submission, goes for both Human and Animal subjects

3

Is proprietary or privileged information included in the application?

Check yes if your application contains: Patentable ideas/ trade secrets. Privileged, confidential commercial, or financial information should be included in applications only when the info is necessary to convey an understanding of the proposed project.

4-6

Self-explanatory

 

7

Project Summary (abstract)

Mention: key focus, long-term goals, relevance to agency’s mission, research design method

 

30 lines of text max

Write in 3rd person

Don’t describe past accomplishments

8

Project Narrative

Relevance to public health

 

Three sentence max

What will your research contribute to the field?

9

Bibliography and references Cited No page limit

Required. All citation formats are acceptable.

10

Facilities and Other Resources

Not required but can help establish the feasibility of the project

Describe how the research site contributes to the probability of success, like, institutional support, physical resources, and intellectual rapport.

11

Equipment

Not required but can help establish the feasibility of the project.

 

Not required

List major items of equipment already available for project and, if possible, where it is and what it can do.

12

Other Attachments

If applicable, Foreign Justification can be attached here

 

No page limit

Do not use this section to attach other parts of the application that did not fit into the page limit, this is grounds for disqualification.

 

 

 

Sites

 

Project/Performance Site

Organization Name:

The Regents of the Univ. of Calif., U.C. San Diego

DUNS Number:

UYTTZT6G9DT1

Street 1:

9500 Gilman Drive

Street 2:

MC: XXXX🡨your home Dept. Mail code

City:

La Jolla

ZIP/Postal Code:

92093-XXXX 🡨Your Dept. Mail Code

Project/Performance Site Congressional District:

CA-050

 

Sr/Key Person Profile

 

Project Director/Principal Investigator

 

Credential, e.g., agency login

Your eRA Commons ID. The system will not submit the application without it!

First name

Your first name

last name

Your last name

Position/Title

Graduate Student Researcher

Department

Your home department

Division

Enter School of Medicine, SKAGGS, or General Campus

Street 1

9500 Gilman Drive

Street 2

MC: XXXX🡨your home Dept. Mail code

City

La Jolla

County/parish

San Diego

state

California

Province

Leave blank

zip/postal code

92093-XXXX 🡨Your Dept. Mail Code

phone/fax

Your personal phone

email

Your email

Project Role

PD/PI

Degree type

Enter highest degree received (DO NOT enter PhD)

Degree Year

Enter the year that the highest degree was received

Biographical sketch

5 page max

To download the format page and to view samples, click here. Do not copy and paste a biosketch. Make sure you are following NIH’s current formatting instructions.

List by institution and year all undergraduate and graduate courses, with grades. Explain any grading system used if it differs from a 1-100 scale; an A, B, C, D, F system; or a 0-4.0 scale

current/pending support

Not required at time of application

 

Senior/Key Person

Follow these instructions for each mentor/co-mentor/consultant

Credential, e.g., agency login

Your eRA Commons ID. The system will not submit the application without it!

 

First/last name

Enter name of mentor as it appears on BLINK

Position/Title

If you are a UCSD professor, look up on BLINK and enter exact title

Department

Professor’s home department

Organization Name

The Regents of the Univ. of Calif., U.C. San Diego

Division

Enter School of Medicine, SKAGGS, General Campus, or Scripps Inst. of Oceanography

Street 1

9500 Gilman Drive

Street 2

MC: XXXX🡨professor’s home Dept. Mail code

City

La Jolla

county

San Diego

state

California

ZIP/Postal Code

92093-XXXX 🡨professor’s Dept. Mail Code

 

Project Role

Other (specify)

Other Project Role

Sponsor (do not write mentor) or Co-sponsor

Degree type/degree year

Enter highest degree received and when it was received

biographical sketch

Refer to PD/PI section above

current/pending support

Not required at time of application

F e l l o w s h i p   S u p p l e m e n t a l   F o r m

1

Introduction

1 page max                   

Only if resubmitting

2

Applicant’s Background and Goals

6 page max

Organize the attachment in these sections with appropriate headings:

 

 

A. Doctoral Dissertation and Research Experience:

  • Briefly summarize your past research experience, results, and conclusions, and describe how that experience relates to the proposed fellowship. In some cases, a proposed fellowship may build directly on previous research experiences, results, and conclusions. In other situations, past research experiences may lead a candidate to apply for a fellowship in a new or different area of research. Do not list academic courses in this section.
  • Applicants with no research experience: Describe any other scientific experiences.
  • Advanced graduate students (i.e., those who have or will have completed their comprehensive examinations by the time of award): Include a narrative of your planned doctoral dissertation (may be preliminary).

B. Training Goals and Objectives

  • Describe your overall training goals for the duration of the fellowship and how the proposed fellowship will enable the attainment of these goals.
  • Identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including, as applicable, expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation, as applicable.
  • Discuss how the proposed research will facilitate your transition to the next career stage

C. Activities Planned Under this Award

  • Briefly summarize your past research experience, results, and conclusions, and describe how that experience relates to the proposed fellowship. In some cases, a proposed fellowship may build directly on previous research experiences, results, and conclusions. In other situations, past research experiences may lead a candidate to apply for a fellowship in a new or different area of research. Do not list academic courses in this section.
  • Applicants with no research experience: Describe any other scientific experiences.
  • Advanced graduate students (i.e., those who have or will have completed their comprehensive examinations by the time of award): Include a narrative of your planned doctoral dissertation (may be preliminary).

 

Research Training Plan

For the next couple of sections

 

 

  • Relate research to your career goals
  • Explain the relationship between the applicant’s research on the fellowship award and the mentor’s ongoing research program.
  • Should be tailored to your experience and allows you to develop career advancing skills

3

Specific aims

1 page max

Goals and expected outcomes

Impact of results

4

Research Strategy

Include the following sub-sections with appropriate headings:

 

6 page max

Tip: If possible, keep section to a max of 5.5 pages, your reviewer will appreciate it

 

Tip 2: Try to include experts in your field of research who might review your application

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 your project will improve scientific knowledge, technical capability, and/or clinical practice in one/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.

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. Unless addressed separately in the Resource Sharing Plan attachment, include how the data will be collected, analyzed, and interpreted, as well as any resource sharing plans, as appropriate. Resources and tools for rigorous experimental design can be found at the Enhancing Reproducibility through Rigor and Transparency website.
  • For trials that randomize groups or deliver interventions to groups, describe how your methods for analysis and sample size are appropriate for your plans for participant assignment and intervention delivery. These methods can include a group- or cluster-randomized trial or an individually randomized group-treatment trial. Additional information is available at the Research Methods Resources webpage.
  • 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. Refer to NIH Guide Notice on Sex as a Biological Variable in NIH-funded Research for additional information.
  • Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. If applicable, 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.
  • If you are proposing to gain clinical trial research experience (i.e., you will not be leading an independent clinical trial), briefly describe your role on the clinical trial.
  • As applicable, also include the following information as part of the Research Strategy, keeping within the two sections (Significance and Approach) listed above.
  • Preliminary Studies for New Applications: For new applications, include information on preliminary studies (including data collected by others in the lab), if any. Discuss the applicant's preliminary studies, data, and/or experience pertinent to this application.

5

Respective Contributions

 

Describe the collaborative process between you and your sponsor/co-sponsor(s) in the development, review, and editing of this Research Training Plan.

 

1 page max

Also discuss your respective goals in accomplishing the proposed research.

6

Selection of Sponsor and institution

1 page max

Explain why you picked your sponsor and why you are doing research on campus.

If you aren’t doing research on campus, explain here.  

Foreign Institution: If you are proposing a research training experience at a foreign institution, describe how the foreign institution and sponsor offer special opportunities for training that are not currently available in the United States

7

Progress Report Pub. List

Leave Blank

8

Training in the Responsible Conduct of Research

1 page max

Include the following subheads in your document:

 

 

  1. Format- format of instruction
  1. Subject matter- describe the breadth of subject matter (Kuali COIs, human and animal subjects, lab safety, ethics, data management, authorship
  1. Faculty participation- role of mentor(s) and co-mentors
  1. Duration of Instruction- total number of contact hours of instruction
  1. Frequency of Instruction- document prior instruction during current career stage, must occur once every 4 years and during each career stage

9

Sponsor and Co-sponsor Statements

6 page max

Include the following subheads in your document:

 

 

 

Each sponsor and co-sponsor statement must address all of the following sections (A-E).

  1. Research Support available- use a table to list all current and pending research and research training support available to you for this project. Include funding source, identifying number, title of research/training program, name of the PD/PI, start and end dates, and the amount of the award.

If one or more co-sponsors is proposed, this plan should describe the role of each sponsor and how they will communicate and coordinate their efforts to mentor the applicant effectively.

  1. Sponsor’s/co-sponsor’s previous fellows/trainees- state total number of pre and post-doctoral individuals that were sponsored.  Select 5 that are representative and list how much time was spent in the lab and who (agency) they work for now and job title.
  1. Training Plan, environment, research facilities- should be tailored to you (the applicant) and to your strengths and weaknesses.

      Designed to enhance research and clinical training. Include items like classes, seminars, professional development opportunities, research environment and available equipment and facilities.

      How does this plan help you reach your career goals? What will you learn that will help you with your career goals?

The information contained in the “Training Plan, Environment, Research Facilities” section of the Sponsor’s and Co-sponsors’ Statements should be coordinated with information provided under the Description of Institutional Environment and Commitment to Training attachment below.

F31, F32, F33 Applications: The Research Training Plan should facilitate the applicant's transition to the next stage of his/her career. Sponsors and co-sponsors should discuss this aspect of the applicant's training as well.

  1. Number of Fellows/Trainees to be supervised during the fellowship- how many fellows/trainees both pre and post doc is the sponsor/co-sponsor expected to supervise during the award period.
  1. Applicant’s qualifications and Potential for a research career- based on your academic record and research experience explain why you are well-suited for this opportunity. How does the research training plan and sponsor expertise help you in becoming an independent researcher? (If you will gain experience in a clinical trial, see NIH guide F-65)

10

Letters of Support (Collaborators, Contributors, and Consultants)

If any collaborators, consultants, or advisors will make contributions to your project/ research training, attach letters of support from them here, describing their role and contributions.

 

6 page max

Different from reference letters; Letters of recommendation are sent directly to NIH via eRA Commons

11

Description of Institutional Environment and Commitment to Training

Include grad program you are currently enrolled in, description of program and structure, required milestones and usual timing, number of courses, teaching commitments, qualifying exams, journal clubs, seminars, clinical requirements, average time to complete the degree over the last 10 years.  Indicate the facilities and other resources that will be made available for both career enhancement and the research proposed in this application.

 

2 page max

 

Where are you in the timeline of the program discussed above? How are you evaluated and monitored?

Include the name of the person who gave you the information (usually chair or director)

12

Description of Candidates Contribution to Program Goals

ONLY students applying for PA-21-052 (NIH F31 Diversity)

 

 

The sponsoring institution must provide a document on institutional letterhead that explains how the candidate’s participation will further the goals of the fellowship program to promote diversity in health-related research.

For NIH’s Interest in Diversity, see the Notice of NIH's Interest in Diversity.

Please have the department Chair sign the letter.

 

13-25 Answer accordingly

More information on the NIH guide

26

Budget Section

Tuition and fees

 

 

Check the box that says funds requested

Use the budget guide attached to email to fill in this section

Please indicate if childcare costs are being requested.

NOTE: BUDGET GUIDE IS ATTACHED TO EMAIL

 

27-29 Leave blank

More information on the NIH guide

 

Human Subjects and Clinical Trial Resources

Link to NIH application guide, Form H. Begins on page F-79.

 

 

 

 

UCSD will not assume responsibility for errors in the applicant’s submission.  We will do our best to review the format of your proposal; however final responsibility for format, content, and completeness rests with the applicant.