FORMS VERSION F SERIES
Released: October 16, 2020
CAREER DEVELOPMENT INSTRUCTIONS
FOR NIH AND OTHER PHS AGENCIES
SF424 (R&R) APPLICATION PACKAGES
Guidance developed and maintained by NIH for preparing and
submitting applications via Grants.gov to NIH and other PHS
agencies using the SF424 (R&R)
TABLE OF CONTENTS
TABLE OF CONTENTS
TABLE OF CONTENTS 2
K.100 - How to Use the Application Instructions 3
K.110 - Application Process 6
K.120 - Significant Changes 10
K.130 - Program Overview 16
K.200 - SF 424 (R&R) Form 18
K.210 - PHS 398 Cover Page Supplement Form 33
K.220 - R&R Other Project Information Form 38
K.230 - Project/Performance Site Location(s) Form 47
K.240 - R&RSenior/Key Person Profile (Expanded) Form 52
K.300 - R&R Budget Form 65
K.310 - R&R Subaward Budget Attachment(s) Form 80
K.410 - PHS 398 Career Development Award Supplemental Form 83
K.500 - PHS Human Subjects and Clinical Trials Information 105
K.600 - PHS Assignment Request Form 142
Form Screenshots i
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.100 - How to Use the Application Instructions
K.100 - How to Use the Application
Instructions
Use these application instructions to fill out the forms that are posted in your funding
opportunity announcement.
View the How to Apply Video Tutorials.
Quick Links
Step 1. Become familiar with the application process
Step 2. Use these instructions, together with the forms and information in the funding opportunity
announcement, to complete your application
Step 3. Choose an application instruction format
Step 4. Complete the appropriate forms
Step 5. Stay informed of policy changes and updates
Step 6. Understand what data NIH makes public
Helpful Links
The information on the following pages may be useful in the application process
l OER Glossary
l Grants Policy Statement
l Guide to Grants and Contracts
l Frequently Asked Questions
Step 1. Become familiar with the application process.
Understanding the application process is critical to successfully submitting your application.
Use the K.110 - Application Process section of these instructions to learn the importance of
completing required registrations before submission, how to submit and track your application,
where to find page limits and formatting requirements, and more information about the
application process.
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.100 - How to Use the Application Instructions
Step 2. Use these instructions, together with the forms and information
found in the funding opportunity announcement, to complete your
application.
The funding opportunity announcement (FOA)will include specific instructions and the forms
needed for your application submission.
Remember that the FOA instructions always supersede these application instructions.
Step 3. Choose an application instruction format.
Do you know your activity code, but don’t know which application instructions to use? Refer to
NIH’s table on Selecting the Correct Application Instructions to determine which set of
application instructions applies to your grant program.
Comprehensive Instructions Program-Specific Instructions
Use the General (G) instructions, available in
both
HTML
and
PDF
format, to complete
the application forms for any type of grant
program.
Take advantage of the filtered PDFs to view
specific application instructions for:
l Research (R)
l Career Development (K)
l Training (T)
l Fellowship (F)
l Multi-project (M)
l SBIR/STTR (B)
Step 4. Complete the appropriate forms.
Unless otherwise specified in the FOA, follow the standard instruction, as well as any additional
program-specific instructions for each form in your application.
Program-specific instructions are presented in gray call-out boxes that are color coded
throughout the application instructions. Consult the K.130 - Program Overview section for
context for program specific instructions.
Step 5. Stay informed of policy changes and updates.
l Refer to the K.120 - Significant Changes section for the most recent changes to these
application instructions.
l Review Notices of NIH Policy Changes since the posting of the Application Guide.
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K.100 - How to Use the Application Instructions
Step 6. Understand what data NIH makes public.
Information submitted as part of the application will be used by reviewers to evaluate the
scientific merit of the application and by NIH staff to make the grant award and monitor the
grant after award. The exception to this is the K.600 - PHS Assignment Request Form, which is
only seen by staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR).
If the application is funded, the following fields will be made available to the public through the
NIH Research Portfolio Online Reporting Tool (RePORTER) and will become public information:
l Name of Project Director/Principal Investigator (PD/PI), to also include Project Leaders on sub-
projects to multi-project projects
l PD/PI title
l PD/PI email address
l Organizational name
l Institutional address
l Project summary/abstract
l Public health relevance statement
In addition, key elements related to ongoing funded projects will be made available to the public,
including those listed in the data dictionary at ExPORTER. Additional elements may be made
available after announcements through the NIH Guide for Grants and Contracts, a weekly
electronic publication that is available on NIH’s Funding page, or additions to the NIH Grants
Policy Statement, as needed.
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K.110 - Application Process
K.110 - Application Process
Understanding the application process is critical to successfully submitting your application.
Use this section of this guide to learn the importance of completing required registrations
before submission; how to submit and track your application; where to find information
about page limits, formatting requirements, due dates, and submission policies; and more
information about the application process. This application process information is also
available on our How to Apply – Application Guide page.
Quick Links
Prepare to Apply and Register
Write Application
Submit
Related Resources
Prepare to Apply and Register
Systems and Roles
Learn about the main systems involved in application submission and the role you and your
colleagues play in the submission process. The main systems are Grants.gov, eRA Commons, and
ASSIST.
Register
Determine your registration status. Organizations, organizational representatives, investigators,
and others need to register in multiple federal systems in order to for you to submit a grant
application. Registration can take six weeks or more to complete. Start today! See NIH’s
Registration website.
Understand Funding Opportunities
Identify the right funding opportunity announcement (FOA) for your research and learn about
key information you will find in the FOA.
Types of Applications
Are you submitting a new, renewal, revision, or resubmission application? Learn about the
different types of applications and special submission requirements.
Submission Options
Determine which system is most convenient for your application submission: NIH’s ASSIST web-
based application submission system, Grants.gov Workspace, or, if applicable, your
organization’s own submission system.
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K.110 - Application Process
Obtain Software
Applicants must have the free Adobe Reader software, a PDF generator, and a web browser to
submit an application. Learn which versions are compatible with our systems.
Write Application
Write Your Application
Read tips for developing a strong application that helps reviewers evaluate its science and merit.
Develop Your Budget
Learn about the kinds of costs you may include in your budget submission, the difference
between modular and detailed budgets, and more about how to develop your budget.
Format Attachments
Follow these requirements for preparing the documents you attach to your application.
Requirements include criteria for the PDF files, fonts, margins, headers and footers, paper size,
citations, formatting pages, etc.
Rules for Text Fields
Learn the rules for form text fields – allowable characters, cutting and pasting, character limits,
and formatting.
Page Limits
Follow the page limits specified in this table for your specific grant program, unless otherwise
specified in the FOA.
Data Tables
Find instructions, blank data tables, and samples to use with institutional research training
applications.
Reference Letters
Some types of programs, such as fellowships and some career development awards, require the
submission of reference letters by the referee. Learn about selecting a referee and find
instructions for submission.
Biosketches
Biosketches are required in both competing applications and progress reports. Find instructions,
blank format pages, and sample biosketches.
Submit
Submit, Track and View
Learn how to submit your application, and about your responsibility for tracking your application
and viewing the application image in the eRA Commons before the application deadline. If you
can’t view your application in eRA Commons, we can’t review it.
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K.110 - Application Process
How We Check for Completeness
Your application will be checked at Grants.gov, by eRA systems, and by federal staff before it is
referred for review.
Changed/Corrected Applications
You will need to submit a changed/corrected application to correct issues that either you or our
systems find with your application. Learn how and when you may submit a changed/corrected
application.
Related Resources
Due Dates and Policies
Due Dates
View standard due dates for competing applications. The FOA will identify whether to follow
standard due dates or whether to follow an alternative due date.
Submission Policies
Learn the nuances of application submission policies, including when late applications might be
allowed, what to do if due dates fall on a weekend or holiday, whether we allow post-submission
materials, how to document system issues, the rules around resubmission applications, etc.
Dealing with System Issues
Are you experiencing system issues with ASSIST, Grants.gov, System for Award Management
(SAM), or the eRA Commons that you believe threaten your ability to submit on time? NIH will not
penalize applicants who experience confirmed issues with federal systems that are beyond their
control. You must report the problem before the submission deadline.
After Submission
Receipt and Referral
Understand how and when applications are given an application identification number and
assigned to a review group and an NIH Institute or Center (IC) for possible funding.
Peer Review
Learn about our two phase peer review process, including initial peer review, Council review,
review criteria, scoring, and summary statements.
Pre-award Process
Learn what happens between peer review and award for applications that have been deemed
highly meritorious in the scientific peer review process. Be ready: if you received a great score in
peer review, you’ll have to submit Just-in-Time information.
Post award Monitoring andReporting
If you receive a grant from the NIH, you will need a lot of information to be a successful steward
of federal funds. This page provides a brief overview of grantee monitoring and reporting
requirements.
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K.110 - Application Process
Resources
News - Items of Interest
The NIH eSubmission Items of Interest page provides comprehensive information, in an informal
format, on the changes impacting application development and submission.
Annotated Form Sets
These handy documents are a great visual resource for understanding many of the validation
checks we will run against your submitted application.
Contacting NIH Staff
NIH staff is here to help. We strongly encourage NIH applicants and grantees to communicate
with us throughout the grant life cycle. Understanding the roles of NIH staff can help you contact
the right person at each phase of the application and award process.
Contacting Staff at Other PHS Agencies
Applicants are strongly encouraged to communicate with agency staff throughout the entire
application review and awards process.
Systems
ASSIST
eRA Commons
Grants.gov
Information Collection
Authorization
The PHS Act establishes the authority with which NIH and other PHS agencies award grants and
collect information related to grant awards.
Paperwork Burden
The paperwork burden provides the estimated time for completing a grant application.
Collection of Personal Demographic Data
NIH collects personal data through the eRA Commons Personal Profile. The data is confidential
and is maintained under the Privacy Act record system.
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.120 - Significant Changes
K.120 - Significant Changes
The Application Instructions are updated and released 2-3 times per year as needed.
Additionally, minor revisions may be made outside of these releases.
This section details all significant changes and revisions made to the instructions since the
last major release.
Within the instructions, new instructions will be marked with this symbol.
In the web version, use your mouse to hover over the icon to read an explanation of the
change.
In a PDF version, this symbol will be visible but will not display hover text. For more
information, see the explanation in the Significant Changes section below.
Revision Notes - October 16, 2020
PHS 398 Career Development Award Supplemental Form
l Under "12. Description of Candidate's Contribution to Program Goals", added hyperlink to Notice
of NIH's Interest in Diversity (NOT-OD-20-031).
PHS 398 Research Training Program Plan Form
l Under section “C. Recruitment Plan to Enhance Diversity” of the “Program Plan”, added hyperlinks
to the Notice of NIH’s Interest in Diversity (NOT-OD-20-031).
PHS Human Subjects and Clinical Trials Information
l Removed language that indicated to skip the rest of the form if you answered “No” to the “Does
the proposed research involve human specimens and/or data?” question.
l Modified text in instruction to “4.1.d. Study Phase” to match form option “N/A”.
Form Screenshots
l Updated form screenshots
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.120 - Significant Changes
Release Notes - February 25, 2020
SF 424 Research and Related (R&R) Form Changes
FORMS-F application packages incorporate the latest versions of the federal-wide forms
managed by Grants.gov (OMB Number: 4040-0001, Expiration Date: 12/31/2022).
SF 424 (R&R) Form
l Clarified instructions regarding Agency Routing Identifier.
l Added instructions for applications proposing the use of human fetal tissue obtained from elective
abortions (HFT):
l Added language under section "21. Cover Letter Attachment," sub-section content (Item
9).
l Updated general and SBIR/STTR instructions for the Type of Applicant question, as “Women
Owned” and “Socially and Economically Disadvantaged” information is now collected though SAM.
l Clarified instruction regarding the content of the "Cover Letter Attachment" to indicate that it
must not be used to communicate application assignment preferences.
R&R Senior/Key Person Profile (Expanded) Form
l Added instructions for Career Development and Fellowship applications for the “Credential, e.g.,
agency login” field under the PD/PI Credential Field of the "Profile- Project Director/Principal
Investigator" section.
l Made minor text edits.
R&R Budget and associated R&R Subaward Budget Attachment(s) Form
l Within section F. Other Direct Costs: “8-10: Other”- removed instruction to list inpatient and
outpatient care costs specifically on lines 8 and 9.
l Within section F. Other Direct Costs: “8-10: Other”- removed note regarding requesting an
exception to the single IRB (sIRB) policy.
l Added instructions for applications proposing the use of human fetal tissue obtained from elective
abortions (HFT):
o
Added special instruction for proposed human fetal tissue research under “Who should use
the R&R Budget Form?”
l Added special instructions under “Additional Instructions for Multi-project”.
l Added special instruction for proposed human fetal tissue research under section “F.8-10.
Other.”
l Added special instruction for proposed human fetal tissue research under section “L. Budget
Justification.”
l Added special instruction for proposed human fetal tissue research under section “F.1. Materials
and Supplies.”
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K.120 - Significant Changes
l Made minor text edits.
Forms-F Changes
PHS 398 Cover Page Supplement Form
l Updated OMB Expiration Date to 2/28/2023
l Added new "Human Fetal Tissue" Section.
l Added instructions for applications proposing the use of human fetal tissue obtained from
elective abortions (HFT).
l Added new "Does the proposed project involve human fetal tissue obtained from elective
abortions?" field.
l Added new instructions and attachment for "HFT Compliance Assurance."
l Added new instructions and attachment for "HFT Sample IRB Consent Form."
l Renumbered form fields.
PHS 398 Modular Budget Form
l Updated OMB Expiration Date to 2/28/2023.
l Added instructions for applications proposing the use of human fetal tissue obtained from
elective abortions (HFT):
l Added special instruction for proposed human fetal tissue research under "Who
should use the PHS 398 Modular Budget Form?"
l Made minor text edits.
PHS 398 Training Budget Form
l Updated OMB Expiration Date to 2/28/2023
PHS 398 Training Subaward Budget Attachment(s) Form
l Updated OMB Expiration Date to 2/28/2023
PHS Additional Indirect Costs Form
l Updated OMB Expiration date to 2/28/2023
PHS 398 Research Plan Form
Updated OMB Expiration Date to 2/28/2023
Clarified instructions on the content of the "Letters of Support" attachment in the "Other
Research Plan Section."
l Removed previous instructions for applications submitted for due dates on or before January
24, 2019 within section 3, "Research Strategy."
l Added instructions for applications proposing the use of human fetal tissue obtained from
elective abortions (HFT):
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K.120 - Significant Changes
o
Under the introductory part of section 3, "Research Strategy": Added new section titled
Note for Applications Proposing the Use of Human Fetal Tissue.
n Within section 3 "Research Strategy", subsection 3 "Approach" - added a new
bullet point for this information titled 'Special Instructions for Proposed Human
Fetal Tissue Research."
l Made minor text edits.
PHS 398 Career Development Award Supplemental Form
l Updated OMB Expiration Date to 2/28/2023
l Added instructions about rigor, experimental design, and quantitative approaches to the
“Candidate Information and Goals for Career Development” section.
l Added new “Description of Candidate’s Contribution to Program Goals” attachment.
l Renumbered form fields.
l Removed previous instructions for applications submitted for due dates on or before January
24, 2019 within section 4 "Research Strategy."
l Added instructions for applications proposing the use of human fetal tissue obtained from
elective abortions (HFT):
o
Under the introductory part of Section 4 "Research Strategy:: Added a new section titled Note
for Applications Proposing the Use of Human Fetal Tissue.
n Within Section 4 "Research Strategy" - subsection 3 "Approach" - added a new bullet
point for this information titled Special Instructions for Proposed Human Fetal Tissue
Research.
l Made minor text edits.
PHS 398 Research Training Program Plan Form
l Updated OMB Expiration Date to 2/28/2023
l Removed previous instructions for applications submitted for due dates on or before January
24, 2019 within Section 8 "Letters of Support."
l Added instructions to the “Proposed Training” section of the “Program Plan” about rigor,
experimental design, and quantitative approaches.
l Added instructions for the “Plan for Instruction in Methods for Enhancing Reproducibility”
attachment.
l Updated instructions for the “Progress Report (for Renewal applications)” attachment.
l Made minor text edits.
PHS Fellowship Supplemental Form
l Updated OMB Expiration Date to 2/28/2023
l Added instructions about rigor, experimental design, and quantitative approaches to the
“Training Goals and Objectives” section of the “Applicant’s Background and Goals for
Fellowship Training” attachment.
l Added instructions for the “Authentication of Key Biological and/or Chemical Resources” field.
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K.120 - Significant Changes
l Added new “Description of Candidate’s Contribution to Program Goals” attachment.
l Renumbered form fields.
l Made minor text edits.
PHS Human Subjects and Clinical Trials Information
l Updated OMB Expiration date to 2/28/2023.
o
Changes were made to the form’s organization in the following sections:
o
Who should use the PHS Human Subjects and Clinical Trials Information form
o
Using the PHS Human Subjects and Clinical Trials Information form
o
Use of Human Specimens and/or Data
l Clarified and updated instructions throughout. Significant changes were made for the
following fields:
o
“Provide the ClinicalTrials.gov Identifier”
o
“Section 2 – Study Population Characteristics” instructions now reflect updated
exceptions for required questions.
o
Study Timeline
o
Section 3.2: "Is this a multi-site study that will use the same protocol to conduct non-
exempt human subjects research at more than one domestic site?" - reflect updated
instructions.
o
“Data and Safety Monitoring Plan” attachment
l Updated instructions for delayed onset studies regarding use of single IRB.
l Added new “Inclusion of Individuals Across the Lifespan” attachment.
l Updated instructions for the “Inclusion of Women and Minorities” attachment to reflect
separate “Inclusion of Individuals Across the Lifespan” attachment.
l Added new “Inclusion Enrollment Report Title” field.
l Removed the “Brief Summary” field.
Changed the “Narrative Study” field to “Detailed Description.”
l Updated instructions to Section 3.2 "Is this a multi-site study that will use the same protocol
to conduct non-exempt human subjects research at more than one domestic site?" and the
single IRB plan attachment.
o
Included instructions specific for AHRQ applicants.
l Included instructions specific for AHRQ applicants to Section 3.3 "Data and Safety Monitoring
Plan."
l Added new "Is this an applicable clinical trial under FDAAA?" field.
l Renumbered form fields.
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K.120 - Significant Changes
PHS Assignment Request Form
l Updated OMB Expiration Date to 2/28/2023.
l Updated language in the form to clarify that this form is for suggestions.
l Removed the “Do Not Assign to Awarding Component” and “Do Not Assign to Study Section”
fields and instructions.
l Added new “Rationale for assignment suggestions” field.
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.130 - Program Overview
K.130 - Program Overview
Quick Links
Individual Research Career Development Award (CDA) Application ("K" Series).
Individual Research Career Development Award (CDA) Application ("K" Series)
The purpose of the career development award (CDA) program is to provide candidates at the
postdoctoral, early career, and mid-career stages with opportunities to build on their initial
research training and to further develop their research careers through individual or institutional
awards.
This section provides instructions for candidates applying for individual career development
awards. Applicants for institutional career development programs, such as the K12 award, should
follow the guidance provided in the "Additional Instructions for Training" sections.
Reference Letters: Instructions for submitting the required reference letters for applicable
programs are not contained in these application instructions. Instead, follow the instructions on
NIH’s Reference Letters page. Referees must submit reference letters through the eRA Commons
by the application due date.
Additional Instructions for Career Development:
Additional career development instructions will be denoted by a gray call-out box
with green color coding and with the heading “Additional Instructions for Career
Development” throughout these application instructions.
Before Applying:
1. Become familiar with Activity Code: Applicants should become familiar with the K
activity code for which support is being requested. A listing of “K” series activity codes,
with their descriptions, is available on the Research Career Development Awards page.
2. Refer to your specific FOA: Refer to your FOA for specific information associated with
the award mechanism, including the eligibility requirements, requirements for a mentor
or mentors, review criteria, award provisions, any special application instructions, and
names of individuals who may be contacted for additional or clarifying information prior
to application submission.
l FOAs and other guidelines are available on the NIH K Kiosk.
l Announcements for various career award opportunities are issued periodically
in the NIH Guide for Grants and Contracts, a weekly electronic publication, that
is available on NIH’s Funding page.
l Some individual K-series programs supported by the NIH include a delayed-
award activation and/or two award phases (e.g., K22, K99/R00). NIH intramural
researchers may be eligible to apply for these awards. The FOA will include any
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.130 - Program Overview
additional and/or specific instructions that must be followed when applying for
such support.
3. Contact Awarding Component: Applicants are encouraged to consult with the NIH
Scientific/Research contact of the appropriate awarding component prior to submitting
an application, as eligibility criteria, support levels, and availability of awards may vary
among NIH Institutes or Centers and other PHS agencies.
The following chart provides a summary of the existing individual career development programs.
Since this information is subject to change, prospective applicants are encouraged to review the
K Kiosk for the most current program information.
Summary of Research Career Development Award Programs
Program Description Mentor
Reference
Letter
K01
Mentored Research Scientist Career Development
Award
Yes Yes
K02 Independent Research Scientist Development Award No No
K05 Senior Research Scientist Award No No
K07 Academic Career Development Award * *
K08
Mentored Clinical Scientist Research Career
Development Award
Yes Yes
K18
Research Career Enhancement Award for Established
Investigators
Yes Yes
K22 Career Transition Award * Yes
K23
Mentored Patient-Oriented Research Career
Development Award
Yes Yes
K24
Mid-Career Investigator Award in Patient-Oriented
Research
No No
K25
Mentored Quantitative Research Career Development
Award
Yes Yes
K26
Mid-Career Investigator Award in Biomedical and
Behavioral Research
No No
K43 Emerging Global Leader Award Yes Yes
K76 Emerging Leaders Career Development Award Yes Yes
K99/R00 Pathways to Independence Award Yes Yes
*Varies with career status and source of award. Check the FOA.
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.200 - SF 424 (R&R) Form
K.200 - SF 424 (R&R) Form
The SF 424 (R&R) Form is used in all grant applications.
This form collects information including type of
submission, applicant information, type of applicant,
and proposed project dates.
View larger image
Quick Links
1. Type of Submission
2. Date Submitted and Applicant Identifier
3. Date Received by State and State Application Identifier
4a. Federal Identifier
4b. Agency Routing Identifier
4c. Previous Grants.gov Tracking ID
5. Applicant Information
6. Employer Identification
7. Type of Applicant
8. Type of Application
9. Name of Federal Agency
10. Catalog of Federal Domestic Assistance Number and Title
11. Descriptive Title of Applicant's Project
12. Proposed Project
13. Congressional District of Applicant
14. Project Director/Principal Investigator Contact Information
15. Estimated Project Funding
16. Is Application Subject to Review by State Executive Order 12372 Process?
17. Certification
18. SFLLL (Disclosure of Lobbying Activities) or Other Explanatory Documentation
19. Authorized Representative
20. Pre-application
21. Cover Letter Attachment
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.200 - SF 424 (R&R) Form
1. Type of Submission
This field is required. Check one of the "Type of Submission" boxes:
Pre-application:
The pre-application option is not used by NIH or other PHS agencies unless specifically noted in a
funding opportunity announcement (FOA).
Application:
An "Application" is a request for financial support of a project or activity submitted on specified
forms and in accordance with NIH instructions. (See NIH Types of Applications for an explanation
of the types of applications).
Changed/Corrected Application:
Check this box if you are correcting either system validation errors or application assembly
problems that occurred during the submission process. Changed/corrected applications must be
submitted before the application due date.
When you submit a changed/corrected application, follow these guidelines:
l After submission of an application, there is a two-day application viewing window. Prior to the
due date, you may submit a changed/corrected application. Submitting a changed/corrected
application will replace the previous submission and remove the previous submission from
consideration.
l If you check the “Changed/Corrected Application” box, then "Field 4.c Previous Grants.gov
Tracking ID” is required.
l Do not use the “Changed/Corrected Application” box to denote a resubmission application.
Resubmission applications will be indicated in “Field 8. Type of Application.” See NIH Glossary
for the definition of Resubmission.
2. Date Submitted and Applicant Identifier
The “Date Submitted” field will auto-populate upon application submission.
Fill in the “Applicant Identifier” field, if applicable. The Applicant Identifier is reserved for applicant
use, not the federal agency to which the application is being submitted.
3. Date Received by State and State Application Identifier
Skip the “Date Received by State” and “State Application Identifier” fields.
4.a. Federal Identifier
New Applications without Pre-application: Leave this field blank.
New Applications following Pre-application: Enter the agency-assigned pre-application
number.
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K.200 - SF 424 (R&R) Form
Resubmission, Renewal, and Revision Applications: The Federal Identifier is required. Include
only the IC and serial number of the previously assigned application/award number (e.g., use
CA987654 from 1R01CA987654-01A1).
4.b. Agency Routing Identifier
Skip the “Agency Routing Identifier” field unless otherwise specified in the FOA or notice in the
NIH Guide for Grants & Contracts.
Applications in response to a NIH Notice of Special Interest require the notice number (e.g., NOT-
IC-FY-XXX) to be entered into this field in order to assign and track applications and awards for
the described initiative.
4.c. Previous Grants.gov Tracking ID
The “Previous Grants.gov Tracking ID” field is required if you checked the “Changed/Corrected
Application” box in “Field 1. Type of Submission.” A Tracking ID number is of the form, for
example, GRANT12345678.
5. Applicant Information
The "Applicant Information" fields reflect information for the applicant organization, not a
specific individual.
Organizational DUNS:
This field is required.
Enter the DUNS or DUNS+4 number of the applicant organization.
This DUNS or DUNS+4 number must match the number entered in the eRA Commons
Institutional Profile (IPF) for the applicant organization. The applicant’s Authorized Organization
Representative (AOR) is encouraged to confirm that a DUNS has been entered into the eRA
Commons IPF prior to application submission. The same DUNS should be used in the eRA
Commons IPF, Grants.gov, System for Award Management (SAM) registration, and in the DUNS
field in the application.
If your organization does not already have a DUNS number, you will need to go to the Dun &
Bradstreet website to obtain the number.
Legal Name:
Enter the legal name of the organization.
Department:
Enter the name of the primary organizational department, service, laboratory, or equivalent level
within the organization.
Division:
Enter the name of the primary organizational division, office, major subdivision, or equivalent
level within the organization.
Street1:
This field is required. Enter the first line of the street address for the applicant organization.
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Street2:
Enter the second line of the street address for the applicant organization.
City:
This field is required. Enter the city for the address of the applicant organization.
County/Parish:
Enter the county/parish for the address of the applicant organization.
State:
This field is required if the applicant organization is located in the United States or its territories.
Enter the state or territory where the applicant organization is located.
Province:
If “Country” is Canada, enter the province of the applicant organization; otherwise, skip the
“Province” field.
Country:
This field is required. Select the country for the address of the applicant organization.
ZIP/Postal Code:
The ZIP+4 is required if the applicant organization is located in the United States. Otherwise, the
postal code is optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the applicant
organization.
Person to be contacted on matters involving this application
This information is for the administrative contact (e.g., AOR or business official), not the PD/PI.
This person is the individual to be notified if additional information is needed and/or if an award
is made.
Prefix:
Enter or select the prefix, if applicable, for the name of the person to contact on matters related
to this application.
First Name:
This field is required. Enter the first (given) name of the person to contact on matters related to
this application.
Middle Name:
Enter the middle name of the person to contact on matters related to this application.
Last Name:
This field is required. Enter the last (family) name of the person to contact on matters related to
this application.
Suffix:
Enter or select the suffix, if applicable, for the name of the person to contact on matters related
to this application.
Position/Title:
Enter the position/title for the person to contact on matters related to this application.
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Street1:
This field is required. Enter the first line of the street address for the person to contact on
matters related to this application.
Street2:
Enter the second line of the street address for the person to contact on matters related to this
application.
City:
This field is required. Enter the city for the address of the person to contact on matters related to
this application.
County/Parish:
Enter the county/parish for the address of the person to contact on matters related to this
application.
State:
This field is required if the person to contact on matters related to this application is located in
the United States or its Territories. Enter the state or territory where the person to contact on
matters related to this application is located.
Province:
If “Country” is Canada, enter the province for the person to contact on matters related to this
application; otherwise, skip the “Province” field.
Country:
Select the country for the address of the person to contact on matters related to this application.
ZIP/Postal Code:
The ZIP+4 is required if the person to contact on matters related to this application is in the
United States. Otherwise, the postal code is optional. Enter the ZIP+4 (nine-digit postal code) or
postal code of the person to contact on matters related to this application.
Phone Number:
This field is required. Enter the daytime phone number for the person to contact on matters
related to this application.
Fax Number:
Enter the fax number for the person to contact on matters related to this application.
E-mail:
Enter the e-mail address for the person to contact on matters related to this application. Only
one e-mail address is allowed, but it may be a distribution list.
6. Employer Identification
This field is required.
Enter either the organization’s Taxpayer Identification Number (TIN) or Employer Identification
Number (EIN) as assigned by the Internal Revenue Service. If your organization is not in the
United States, enter 44-4444444. Your EIN may be 12 digits, and if this is the case, enter all 12
digits.
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7. Type of Applicant
This field is required.
In the first field under “7. Type of Applicant,” enter the appropriate applicant type. If your
applicant type is not specified (e.g., for eligible Agencies of the Federal Government), select “X:
Other (specify),” and indicate the name (e.g., the appropriate federal agency) in the space below.
Other (Specify):
Complete only if “X. Other (specify)” is selected as the "Type of Applicant."
Women Owned:
Do not use the "Women Owned" checkbox.
Socially and Economically Disadvantaged:
Do not use the "Socially and Economically Disadvantaged" checkbox.
Note: NIH, CDC, and FDA use the Business Type information provided in the System for Award
Management entity record for the applicant organization, rather than the “Woman Owned” and
“Socially and Economically Disadvantaged” checkboxes, to determine the small business
organization type. For more information, see the NIH Guide Notice on Small Business
Organization Type Information Pulled from System for Award Management Record Rather than
Grant Application Form.
8. Type of Application
This field is required.
Select the type of application. Check only one application type. Use the following list of existing
definitions to determine what application type you have. For more information, see NIH Types of
Applications.
l New. Check this option when submitting an application for the first time or in
accordance with other submission policies. See the NIH Grants Policy Statement, Section
2.3.7.4: Submission of Resubmission Application.
l Resubmission. Check this option when submitting a revised (altered or corrected) or
amended application. See also the NIH Application Submission Policies. If your
application is both a “New/Revision/Renewal” and a “Resubmission,” check only the
“Resubmission” box.
l Renewal. Check this option if you are requesting additional funding for a period
subsequent to that provided by a current award. A renewal application competes with
all other applications and must be developed as fully as if the applicant were applying for
the first time.
l Continuation. The box for “Continuation” is used only for specific FOAs.
l Revision. Check this option for competing revisions and non-competing administrative
supplements. For more information on competing revisions, see NIH Competing
Revisions. For more information on administrative supplements, see NIH Administrative
Supplements.
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Additional Instructions for Career Development:
The applicant should generally check “New” or “Resubmission.” Unless otherwise
specified in the FOA, individual career development awards usually cannot be
renewed, supplemented, or revised. Contact the awarding component staff or refer
to the FOA if clarification is needed.
If Revision, mark appropriate box(es).
You may select more than one.
A. Increase Award
B. Decrease Award
C. Increase Duration
D. Decrease Duration
E. Other (specify)
If “E. Other (specify)” is selected, specify in the space provided.
The boxes for options B, C, D, and E will generally not be used and should not be selected unless
specifically addressed in a particular FOA.
Is this application being submitted to other agencies? What Other Agencies?
In the field “Is this application being submitted to other agencies?” check “Yes” if one or more of
the specific aims submitted in your application is also contained in a similar, identical, or
essentially identical application submitted to another federal agency.
Otherwise, check "No."
If you checked "Yes," indicate the agency or agencies to which the application has been
submitted.
9. Name of Federal Agency
The “Name of Federal Agency” field is pre-populated from the opportunity package and reflects
the agency from which assistance is being requested with this application.
10. Catalog of Federal Domestic Assistance Number and Title
This field is pre-populated from the opportunity package and reflects the Catalog of Federal
Domestic Assistance (CFDA) number of the program under which assistance is requested.
This field may be blank if you are applying to an opportunity that references multiple CFDA
numbers. When this field is blank, leave it blank. The appropriate CFDA number will be
automatically assigned by the agency once the application is assigned to the appropriate
awarding component.
11. Descriptive Title of Applicant’s Project
This field is required.
Enter a brief descriptive title of the project.
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The descriptive title is limited to 200 characters, including spaces and punctuation.
New Applications: You must have a title different than any other NIH or other PHS Agency
project submitted for the same application due date with the same Project Director/Principal
Investigator (PD/PI).
Resubmission or Renewal Applications: You should normally have the same title as the
previous grant or application; however, if the specific aims of the project have significantly
changed, choose a new title.
Revision Applications: You must have the same title as the currently funded grant.
12. Proposed Project
Start Date:
This field is required. Enter the proposed start date of the project. The start date is an estimate,
and is typically at least nine months after application submission. The project period should not
exceed what is allowed in the FOA.
Ending Date:
This field is required. Enter the proposed ending date of the project.
13. Congressional District of Applicant
Enter the Congressional District as follows: a 2-character state abbreviation, a hyphen, and a 3-
character district number. Examples: CA-005 for California’s 5th district, VA-008 for Virginia’s 8th
district.
If outside the United States, enter 00-000.
For States and U.S. Territories with only a single congressional district, enter “001” for the district
number.
For jurisdictions with no representative, enter “099.”
For jurisdictions with a nonvoting delegate, enter “098” for the district number. Example: DC-098
or PR-098.
If you do not know your Congressional District: Go to The United States House of
Representatives website and search for your Congressional District by entering your ZIP+4. If you
do not know your ZIP+4, look it up on the USPS Look Up Zip Code website.
14. Project Director/Principal Investigator Contact Information
This information is for the PD/PI. The PD/PI is the individual responsible for the overall scientific
and technical direction of the project.
In the eRA Commons profile, the person listed here in “14. Project Director/Principal Investigator
Contact Information” must be affiliated with the applicant organization entered in “5. Applicant
Information.” If you are proposing research at an institute other than the one you are currently
at, do not create a separate Commons account with the proposed applicant organization. For
additional information on creating affiliations for users in the eRA Commons, see eRA Account
Management System's Online Help.
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If submitting an application reflecting multiple PD/PIs, the individual listed here as the Contact
PD/PI in “14. Project Director/Principal Investigator Contact Information” will be the first PD/PI
listed in K.240 - R&RSenior/Key Person Profile (Expanded) Form.
See K.240 - R&R Senior/Key Person Profile (Expanded) Form for additional instructions for
multiple PD/PIs. To avoid potential errors and delays in processing, ensure that the information
provided in this section is identical to the PD/PI profile information contained in the eRA
Commons.
Additional Instructions for Career Development:
Provide the name of the individual candidate (considered the PD/PI for career
development award programs). If the PD/PI is not located at the applicant
organization at the time the application is submitted, the information should
reflect where the candidate can be reached prior to the requested award start
date. If the PD/PI is not located at the applicant organization at the time of
submission, the Commons account for the PD/PI must be affiliated with the
applicant organization.
If your proposed career award is at a different site than your current institution,
the proposed sponsoring institution will be the applicant organization. You must
affiliate your Commons account with the institution so that you have access to
records submitted on your behalf. Do not create a separate Commons account
with the proposed sponsoring institution.
Note: For some career transition award programs (e.g., K22) the applicant may
apply without an institutional affiliation. These individuals should refer to the
specific FOA for application instructions.
Multiple PD/PIs cannot apply for individual career development awards.
Prefix:
Enter or select the prefix, if applicable, for the name of the PD/PI.
First Name:
This field is required. Enter the first (given) name of the PD/PI.
Middle Name:
Enter the middle name of the PD/PI.
Last Name:
This field is required. Enter the last (family) name of the PD/PI.
Suffix:
Enter or select the suffix, if applicable, for the PD/PI. Do not use this field to record degrees (e.g.,
Ph.D. or M.D.). Degrees for the PD/PI are requested separately in the R&R Senior/Key Person
Profile (Expanded) Form.
Position/Title:
Enter the position/title of the PD/PI.
Organization Name:
This field is required. This field may be pre-populated from the applicant information section in
this form.
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Department:
Enter the name of primary organizational department, service, laboratory, or equivalent level
within the organization of the PD/PI.
Division:
Enter the name of primary organizational division, office, major subdivision, or equivalent level
within the organization of the PD/PI.
Street1:
This field is required. Enter first line of the street address for the PD/PI.
Street2:
Enter the second line of the street address for the PD/PI.
City:
This field is required. Enter the city for the address of the PD/PI.
County/Parish:
Enter the county/parish for the address of the PD/PI.
State:
This field is required if the PD/PI is located in the United States or its Territories. Enter the state or
territory where the PD/PI is located.
Province:
If “Country” is Canada, enter the province for the PD/PI; otherwise, skip the “Province” field.
Country:
Select the country for the PD/PI.
ZIP/Postal Code:
The ZIP+4 is required if the PD/PI address is in the United States. Otherwise, the postal code is
optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the PD/PI.
Phone Number:
This field is required. Enter the daytime phone number for the PD/PI.
Fax Number:
Enter the fax number for the PD/PI.
E-mail:
This field is required. Enter the e-mail address for the PD/PI.
15. Estimated Project Funding
All four fields in “15. Estimated Project Funding” are required.
a. Total Federal Funds Requested
Enter the total federal funds, including Direct Costs and F&A Costs (Indirect Costs), requested for
the entire project period.
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b. Total Non-Federal Funds
For applications to NIH and other PHS agencies, enter “0” in this field unless cost sharing is a
requirement for the specific FOA.
c. Total Federal & Non-Federal Funds
Enter the total federal and non-federal Funds requested. The amount in this field will be the
same as the amount in the “Total Federal Funds Requested” field unless the specific FOA
indicates that cost sharing is a requirement.
d. Estimated Program Income
Indicate any program income estimated for this project, if applicable.
16. Is Application Subject to Review by State Executive Order 12372 Process?
Applicants should check “No, Program is not covered by E.O. 12372.”
17. Certification
This field is required.
The list of NIH and other PHS agencies Certifications, Assurances, and other Policies is found in
the NIH Grants Policy Statement, Section 4: Public Policy Requirements and Objectives.
The applicant organization is responsible for verifying its eligibility and the accuracy, validity, and
conformity with the most current institutional guidelines of all the administrative, fiscal, and
scientific information in the application, including the Facilities and Administrative rate.
Deliberate withholding, falsification, or misrepresentation of information could result in
administrative actions, such as withdrawal of an application, suspension and/or termination of
an award, debarment of individuals, as well as possible criminal and/or civil penalties. The signer
further certifies that the applicant organization will be accountable both for the appropriate use
of any funds awarded and for the performance of the grant-supported project or activities
resulting from this application. The grantee institution may be liable for the reimbursement of
funds associated with any inappropriate or fraudulent conduct of the project activity.
Check “I agree” to provide the required certifications and assurances.
18. SFLLL (Disclosure of Lobbying Activities) or Other Explanatory Documentation
If applicable, attach the SFLLL or other explanatory document as per FOA instructions.
If unable to certify compliance with the Certification in the “17. Certification” section above,
attach an explanation. Additionally, as applicable, attach the SFLLL (Standard Form LLL, Disclosure
of Lobbying Activities) or other documents in this item.
For more information:
See the NIH Grants Policy Statement, Section 4.1.17: Lobbying Prohibition, and the NIH Lobbying
Guidance for Grantee Activities page.
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19. Authorized Representative
The authorized representative is equivalent to the individual with the organizational authority to
sign for an application. This individual is otherwise known as the authorized organization
representative (AOR) in Grants.gov or the signing official (SO) in eRA Commons.
Prefix:
Enter or select the prefix, if applicable, for the name of the AOR/SO.
First Name:
This field is required. Enter the first (given) name of the AOR/SO
Middle Name:
Enter the middle name of the AOR/SO.
Last Name:
This field is required. Enter the last (family) name of the AOR/SO.
Suffix:
Enter or select the suffix, if applicable, for the AOR/SO.
Position/Title:
This field is required. Enter the position/title of the name of the AOR/SO.
Organization Name:
This field is required. Enter the name of the organization for the AOR/SO.
Department:
Enter the name of the primary organizational department, service, laboratory, or equivalent level
within the organization for the AOR/SO.
Division:
Enter the name of the primary organizational division, office, major subdivision, or equivalent
level within the organization for the AOR/SO.
Street1:
This field is required. Enter the first line of the street address for the AOR/SO.
Street2:
Enter the second line of the street address for the AOR/SO.
City:
This field is required. Enter the city for the address of the AOR/SO.
County/Parish:
Enter the county/parish for the address of the AOR/SO.
State:
This field is required if the AOR/SO is located in the United States or its Territories. Enter the state
or territory where the AOR/SO is located.
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Province:
If “Country” is Canada, enter the province for the AOR/SO; otherwise, skip the “Province” field.
Country:
Select the country for the address of the AOR/SO.
ZIP/Postal Code:
The ZIP+4 is required if the AOR/SO is in the United States. Otherwise, the postal code is optional
Enter the ZIP+4 (nine-digit postal code) or postal code of the AOR/SO.
Phone Number:
This field is required. Enter the daytime phone number for the AOR/SO.
Fax Number:
Enter the fax number for the AOR/SO.
Email:
This field is required. Enter the e-mail address for the AOR/SO.
Signature of Authorized Representative:
Grants.gov will record the electronic signature for the AOR/SO who submits the application.
It is the organization’s responsibility to assure that only properly authorized individuals sign in
this capacity and/or submit the application to Grants.gov.
Date Signed:
Grants.gov will generate this date upon application submission.
20. Pre-application
Unless specifically noted in a FOA, NIH and other PHS agencies do not use pre-applications. The
"Pre-application" attachment field should not be used for any other purpose.
If permitted by your FOA, attach this information as a PDF.
21. Cover Letter Attachment
The cover letter is for internal use only and will not be shared with peer reviewers.
Who must complete the “Cover Letter Attachment:”
Refer to the “content” list below for items that are permitted, as well as for specific situations in
which a cover letter must be included.
A cover letter must not be included with post-award submissions, such as administrative
supplements, change of grantee institution, or successor-in-interest.
Format:
Attach the cover letter, addressed to the Division of Receipt and Referral, in accordance with the
FOA and/or these instructions.
Attach the cover letter in the correct location, specifically verifying that the cover letter has
not been uploaded to the “20. Pre-application” field which is directly above the “21. Cover
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Letter Attachment” field. This will ensure the cover letter attachment is kept separate from the
assembled application in the eRA Commons and made available only to appropriate staff.
Content:
Do not use the cover letter to communicate application assignment preferences. The
Assignment Request Form is provided for that purpose.
The letter should contain any of the following information, as applicable:
1. Application title.
2. Title of FOA (PA or RFA).
3. For late applications (see Late Application policy on NIH's Application Submission
Policies) include specific information about the timing and nature of the delay.
4. For changed/corrected applications submitted after the due date, a cover letter is
required, and it must explain the reason for late submission of the changed/corrected
applications. If you already submitted a cover letter with a previous submission and are
now submitting a late change/corrected application, you must include all previous cover
letter text in the revised cover letter attachment. The system does not retain any
previously submitted cover letters; therefore, you must repeat all information previously
submitted in the cover letter as well as any additional information.
5. Explanation of any subaward budget components that are not active for all budget
periods of the proposed grant (see K.310 – R&R Subaward Budget Attachment(s) Form).
6. Statement that you have attached any required agency approval documentation for the
type of application submitted. This may include approval for applications that request
$500,000 or more, approval for Conference Grant or Cooperative Agreement (R13 or
U13), etc. It is recommended that you include the official communication from an NIH
official as part of your cover letter attachment.
7. When intending to submit a video as part of the application, the cover letter must
include information about the intent to submit it; if this is not done, the video will not be
accepted. See NIH Grants Policy Statement, Section 2.3.7.7: Post Submission Grant
Application Materials for additional information.
8. Include a statement in the cover letter if the proposed studies will generate large-scale
human or non-human genomic data as detailed in the NIH Genomic Data Sharing Policy
(see the NIH Grants Policy Statement, Section 2.3.7.10: NIH Genomic Data Sharing and
Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/Policy for Genome-Wide Association
Studies (GWAS)).
9.
1
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. For further
information on HFTpolicy refer to the NIHGrants 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.
1
A statement is required in the cover letter if the studies proposed involve human fetal tis-
sue for any reason. See NIH GPS 2.3.7.11, 4.1.14 and 4.1.14.2
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Additional Instructions for Career Development:
Mentored Career Development Award (CDA) applicants must include a cover
letter that contains a list of referees (including name, departmental affiliation, and
institution).
Non-mentored CDA applicants are encouraged, but not required, to include a
cover letter. The cover letter should include a list of referees (including name,
departmental affiliation, and institution).
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K.210 - PHS 398 Cover Page Supplement Form
K.210 - PHS 398 Cover Page Supplement
Form
The PHS 398 Cover Page Supplement Form is used for all
grant applications except fellowships. This form collects
information on human subjects, vertebrate animals,
program income, human embryonic stem cells, inventions
and patents, and changes of investigator/change of
institution.
View larger image
Quick Links
1. Vertebrate Animals Section
2. Program Income Section
3. Human Embryonic Stem Cell Section
4. Human Fetal Tissue Section.
5. Inventions and Patents Section (for Renewal applications)
6. Change of Investigator/Change of Institution Section
1. Vertebrate Animals Section
Are vertebrate animals euthanized?
You must answer this question if you answered “Yes” to the question “Are Vertebrate Animals
Used?” on the K.220 – R&R Other Project Information Form.
Check "Yes" or "No" to indicate whether vertebrate animals in the project are euthanized.
If “Yes” to euthanasia: Is method consistent with American Veterinary Medical Association
(AVMA) guidelines?
You must answer this question if you answered “Yes” to the “Are vertebrate animals euthanized?”
question above. Check “Yes” or “No” to indicate whether the method of euthanasia is consistent
with the AVMA Guidelines for the Euthanasia of Animals.
For more information: See AVMA Guidelines for the Euthanasia of Animals.
If “No” to AVMA guidelines, describe method and provide scientific justification:
If you answered “No” to the “Is method consistent with AVMA guidelines?” question, you must
describe (in 1000 characters or fewer) the method of euthanasia and provide a scientific
justification for its use. This justification will be reviewed by Office of Laboratory Animal Welfare
(OLAW).
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If you answered “Yes” to the “Is method consistent with AVMA guidelines” question, skip this
question.
2. Program Income Section
Is program income anticipated during the periods for which the grant support is requested?
This field is required.
If program income is anticipated during the periods for which grant support is requested, check
“Yes,” and complete the rest of the “Program Income” section.
If no program income is anticipated, check “No” and skip the rest of the “Program Income”
section.
Budget Period:
Enter the budget periods for which program income is anticipated. If the application is funded,
the Notice of Grant Award will provide specific instructions regarding the use of such income.
Anticipated Amount ($):
Enter the amount of anticipated program income for each budget period listed.
Source(s):
Enter the source of anticipated program income for each budget period listed.
3. Human Embryonic Stem Cells Section
Use the following instructions to complete the fields in this section.
For additional guidance, see the NIH Grants Policy Statement, Section 4.1.13: Human Stem Cell
Research.
Does the proposed project involve human embryonic stem cells?
This field is required.
If the proposed project involves human embryonic stem cells (hESC), check “Yes” and complete
the rest of the “Human Embryonic Stem Cells” section.
If the proposed project does not involve hESC, check “No” and skip the rest of the “Human
Embryonic Stem Cells” section.
Specific stem cell line cannot be referenced at this time. One from the registry will be used.
If you will use hESC but a specific line from the NIH hESC Registry cannot be chosen at the time of
application submission, check this box.
If you cannot specify which cell lines will be used at the time of application submission, specific
cell line information will be required as Just-in-Time information prior to award.
Additional Instructions for Career Development:
If you cannot choose an appropriate cell line from the registry at this time, provide
a justification in the K.410 - PHS 398 Career Development Award Supplemental
Form, Research Strategy attachment.
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Cell Line(s):
List the 4-digit registration number of the specific cell line(s) from the NIH hESC Registry (e.g.
0123). Up to 200 lines can be added.
For more information:
See NIH’s Stem Cell Information page for additional information on stem cells, Federal policy
statements, and guidelines on federally funded stem cell research.
4. Human Fetal Tissue Section
Does the proposed project involve human fetal tissue from elective abortions?
This field is required.
If the proposed project involves the use of human fetal tissue obtained from elective abortions
(HFT), check “Yes” and complete the rest of the “Human Fetal Tissue” section.
If the proposed project does not involve the use of human fetal tissue obtained from elective
abortions (HFT), check “No” and skip the rest of the “Human Fetal Tissue” section.
If the answer is "yes" then provide the HFT Compliance Assurance:
If the proposed project involves the use of human fetal tissue obtained from elective abortions
(HFT), the applicant must provide a letter, signed by the PD/PI, assuring the HFT donating
organization or clinic adheres to the requirements of the informed consent process and
documenting that HFT was not obtained or acquired for valuable consideration. The PDF-
formatted letter must be named ‘HFTComplianceAssurance.pdf’.
If the answer is “yes” then provide the HFT Sample IRB Consent Form
If the proposed project involves the use of human fetal tissue obtained from elective abortions
(HFT), provide a blank sample of the IRB-approved consent form. The PDF-formatted form must
be a blank sample and named ‘HFTSampleIRBConsentForm.pdf’.
o The informed consent for use of HFT from elective abortions requires language that
acknowledges informed consent for donation of HFT was obtained by someone other than the
person who obtained the informed consent for abortion, that informed consent for donation of
HFT occurred after the informed consent for abortion was obtained will not affect the method of
abortion, and that no enticements, benefits, or financial incentives were used at any level of the
process to incentivize abortion or the donation of HFT. The form must be signed by both the
woman and the person who obtains the informed consent.
For further information on HFTpolicy refer to the NIHGrants 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.
5. Inventions and Patents Section (for Renewal applications)
Who must complete the “Invention and Patents” section:
Complete the "Inventions and Patents" section only if you are submitting a renewal application or a
resubmission of a renewal application.
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K.210 - PHS 398 Cover Page Supplement Form
Inventions and Patents:
If no inventions were conceived or reduced to practice during the course of work under this
project, check “No” and skip the remainder of the “Inventions and Patents” section.
If any inventions were conceived or first actually reduced to practice during the previous period
of support, check “Yes.”
NIH recipient organizations must promptly report inventions to the Division of Extramural
Inventions and Technology Resources (DEITR) Branch of the Office of Policy for Extramural
Research Administration (OPERA), OER, NIH, 6705 Rockledge Drive, Bethesda, MD 20892-2750,
(301) 435-1986. You must report inventions in compliance with regulations at 37 CFR 401.14,
which are described at Interagency Edison (iEdison). The grantee is required to submit reports
electronically using iEdison. See the NIH Grants Policy Statement, Section 8.4.1.6: Invention
Reporting.
Additional Instructions for Career Development:
Skip the “Inventions and Patents” section, as it is not applicable.
Previously Reported:
If you answered “Yes” to the “Inventions and Patents” question, indicate whether this
information has been reported previously to the NIH or PHS agency or to the applicant
organization official responsible for patent matters.
6. Change of Investigator/Change of Institution Section
Change of Project Director/Principal Investigator:
Check this box if your application reflects a change in project director/principal investigator
(PD/PI) from that indicated on your previous application or award. Note that this box not
applicable to a new application, nor is a change in PD/PI permitted for revision applications.
For a multiple PD/PI application, check this box if this application represents a change in the
contact PI.
If you check the box, fill in the rest of the “Change of PD/PI” section with the information for the
former PD/PI according to the instructions below.
Additional Instructions for Career Development:
Skip the “Change of Project Director/Principal Investigator” section, as changes in
PD/PI are not allowed for career development awards.
Prefix:
Enter or select the prefix, if applicable, for the former PD/PI.
First Name:
Enter the first (given) name of the former PD/PI.
Middle Name:
Enter the middle name of the former PD/PI.
Last Name:
Enter the last (family) name of the former PD/PI.
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Suffix:
Enter or select the suffix, if applicable, for the former PD/PI.
Change of Grantee Institution:
Check this box if your application reflects a change in grantee institution from that indicated
on your previous application or award. This question is not applicable to new applications.
Name of Former Institution:
Enter the name of the former institution if this application reflects a change in grantee
institution.
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K.220 - R&R Other Project Information Form
K.220 - R&R Other Project Information
Form
The R&R Other Project Information Form is used for all
grant applications. This form includes questions on the
use of human subjects, vertebrate animals, and
environmental impact. This form also has fields to
upload an abstract, project narrative, references,
information on facilities, and equipment lists.
View larger image
Quick Links
1. Are Human Subjects Involved?
1a. If YES to Human Subjects
2. Are Vertebrate Animals Used?
2a. If YES to Vertebrate Animals
3. Is proprietary/privileged information included in the application?
4. Environmental Questions
5. Is the research performance site designated, or eligible to be designated, as a historic place?
6. Does this project involve activities outside of the United States or partnerships with inter-
national collaborators?
7. Project Summary/Abstract
8. Project Narrative
9. Bibliography & References Cited
10. Facilities & Other Resources
11. Equipment
12. Other Attachments
1. Are Human Subjects Involved?
This field is required.
If activities involving human subjects are planned at any time during the proposed project at any
performance site, check “Yes.” Check “Yes” even if the proposed project is exempt from
regulations for the Protection of Human Subjects, or if activities involving human subjects are
anticipated within the period of award but plans are indefinite.
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K.220 - R&R Other Project Information Form
If activities involving human subjects are not planned at any time during the proposed project at
any performance site, select “No” and skip the rest of the "Are Human Subjects Involved" section.
Whether you answer “Yes” or “No” to the “Are Human Subjects Involved?” question here, your
answer will populate the relevant field in the K.500 – PHS Human Subjects and Clinical Trials
Information form (see exception for Training Applications in the Training-specific instructions).
Follow the K.500 – PHS Human Subjects and Clinical Trials Information form instructions to
complete the relevant questions in that form.
Need help determining whether your application includes human subjects? Check out the
NIH Research Involving Human Subjects website for information, including an Infopath
Questionnaire designed to walk applicants through the decision process.
Note on the use of human specimens or data: Applications involving the use of human
specimens or data may or may not be considered to be research involving human subjects,
depending on the details of the materials to be used. If you check “No” to “Are Human Subjects
Involved?” but your application proposes using human specimens or data, you will be required to
provide a clear justification about why this use does not constitute human subjects research.
Follow the K.500 – PHS Human Subjects and Clinical Trials Information form instructions.
For more information on human biospecimens or data: Refer to the NIH page on Frequently
Asked Questions on Human Specimens, Cell Lines, or Data and the Research Involving Private
Information or Biological Specimens flowchart.
1.a. If YES to Human Subjects
Your answers here in question “1.a. If YES to Human Subjects” will populate the corresponding
fields in the K.500 – PHS Human Subjects and Clinical Trials Information form.
Is the Project Exempt from Federal regulations? Yes/No
If the project is exempt from federal regulations, check “Yes” and check the appropriate
exemption number.
Human subjects research should only be designated as exempt if all of the proposed research
projects in an application meet the criteria for exemption.
If the project is not exempt from federal regulations, check “No.”
For more information, see the NIH’s Exempt Human Subjects Research infographic.
If yes, check appropriate exemption number 1, 2, 3, 4, 5, 6, 7, 8:
If you selected “Yes” to “Is the Project Exempt from Federal Regulations,” select the appropriate
exemption number.
The categories of research that qualify for exemption are defined in the Common Rule for the
Protection of Human Subjects. These regulations can be found at 45 CFR 46.
Need help determining the appropriate exemption number? Refer to NIH's Research Involving
Human Subjects Frequently Asked Questions.
The Office of Human Research Protections (OHRP) guidance states that appropriate use of
exemptions described in 45 CFR 46 should be determined by an authority independent from the
investigators (for more information, see OHRP's Frequently Asked Questions). Institutions often
designate their Institutional Review Board (IRB) to make this determination. Because NIH does
not require IRB approval at the time of application, the exemptions designated often represent
the opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is
evaluated during peer review.
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K.220 - R&R Other Project Information Form
If no, is the IRB review Pending? Yes/No
If IRB review is pending, check “Yes.”
Applicants should check “Yes” to the question “Is the IRB review Pending?” even if the IRB
review/approval process has not started by the time of submission.
If IRB review is not pending (e.g., if the review is complete), check “No.”
IRB Approval Date:
Enter the latest IRB approval date (if available). Leave blank if IRBapproval is pending.
An IRB approval date is not required at the time of submission when IRB review is pending. This
may be requested later in the pre-award cycle as a Just-In-Time requirement. See the NIH Grants
Policy Statement, Section 2.5.1: Just-in-Time Procedures for more information.
Human Subject Assurance Number:
Enter the approved Federalwide Assurance (FWA) number that the applicant has on file with
OHRP. Enter the 8-digit number. Do not enter “FWA” before the number.
Enter “None” if the applicant organization does not have an approved FWA on file with OHRP. In
this case, the applicant organization, by the signature in the Certification section on the K.200 -
SF424 (R&R) Form, is declaring that it will comply with 45 CFR 46 and proceed to obtain a FWA
(see Office for Human Research Protections website). Do not enter the FWA number of any
collaborating institution.
2. Are Vertebrate Animals Used?
This field is required.
If activities involving vertebrate animals are planned at any time during the proposed project at
any performance site, check “Yes.” Otherwise, check “No” and skip the rest of the “2. Are
Vertebrate Animals Used?” section.
Note that the generation of custom antibodies constitutes an activity involving vertebrate
animals.
If animal involvement is anticipated within the period of award but plans are indefinite, check
"Yes."
Additional Instructions for Career Development:
If you have answered “Yes” to the “Are Vertebrate Animals Used?” question, you
must also provide an explanation and anticipated timing of animal use in K.410 -
PHS 398 Career Development Award Supplemental Form, Vertebrate Animals. This
attachment must be submitted and reviewed prior to the involvement of animals in
any research studies.
2.a. If YES to Vertebrate Animals
Is the IACUC review Pending?
If an Institutional Animal Care and Use Committee (IACUC) review is pending, check "Yes."
Applicants should check “Yes” to the "Is the IACUC review Pending?" question even if the IACUC
review/approval process has not started by the time of submission.
If IACUC review is not pending (e.g. if the review is complete), check “No."
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IACUC Approval Date:
Enter the latest IACUC approval date (if available). Leave blank if IACUC approval is pending.
IACUC approval must have been granted within three years of the application submission date to
be valid.
An IACUC approval date is not required at the time of submission. NIH does not require
verification of review and approval of the proposed research by the IACUC before peer review of
the application. However, this information is required under the NIH Grants Policy Statement
Section 2.5.1: Just-in-Time Procedures.
Animal Welfare Assurance Number
Enter the federally approved assurance number, if available.
Enter “None” if the applicant organization does not have an Office of Laboratory Animal Welfare
(OLAW)-approved Animal Welfare Assurance.
To determine whether the applicant organization holds an Animal Welfare Assurance with an
associated number, see the lists of Domestic and Foreign Assured institutions. Do not enter the
Animal Welfare Assurance number for a Project/Performance Site of a collaborating
institution.
When an applicant organization does not have an Animal Welfare Assurance number, the
authorized organization representative’s signature on the application constitutes declaration
that the applicant organization will submit an Animal Welfare Assurance when requested by
OLAW.
If the animal work will be conducted at an institution with an Animal Welfare Assurance and the
applicant organization does not have the following:
l an animal care and use program;
l facilities to house animals and conduct research on site; and
l IACUC;
then, the applicant must obtain an Inter-institutional Assurance from OLAW prior to an award.
3. Is proprietary/privileged information included in the application?
This field is required.
Patentable ideas; trade secrets; or privileged, confidential commercial, or financial information
should be included in applications only when such information is necessary to convey an
understanding of the proposed project.
If the application includes such information, check “Yes” and clearly mark each line or paragraph
on the pages containing the proprietary/privileged information with a statement similar to: “The
following contains proprietary/privileged information that (name of applicant) requests not be
released to persons outside the government, except for purposes of review and evaluation.” This
statement can be included at the top of each page as applicable.
If a grant is awarded as a result of or in connection with the submission of this application, the
government shall have the right to use or disclose the information to the extent authorized by
law. Although the grantee institution and the PD/PI will be consulted about any such disclosure,
the NIH and other PHS agencies will make the final determination. Any indication by the applicant
that the application contains proprietary or privileged information does not automatically shield
the information from release in response to a Freedom of Information Act (FOIA) request should
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the application result in an award (see 45 CFR 5). Additionally, if an applicant fails to identify
proprietary information at the time of submission as instructed here, a significant substantive
justification will be required to withhold the information if requested under FOIA.
4. Environmental Questions
Question 4 pertains to the environmental impact of the proposed research.
4.a. Does this Project Have an Actual or Potential Impact - positive or negative - on the envir-
onment?
This field is required.
Indicate whether or not this project has an actual or potential impact on the environment.
Most NIH research grants are not expected to individually or cumulatively have a significant effect
on the environment, and NIH has established several categorical exclusions allowing most
applicants to answer “No” unless a specific FOA indicates that the National Environmental Policy
Act (NEPA) applies. However, if an applicant expects that the proposed project will have an actual
or potential impact on the environment, or if any part of the proposed research and/or project
includes one or more of the following scenarios, check “Yes.”
1. The potential environmental impacts of the proposed research may be of greater scope
or size than other actions included within a category.
2. The proposed research threatens to violate a federal, state, or local law established for
the protection of the environment or for public health and safety.
3. Potential effects of the proposed research are unique or highly uncertain.
4. Use of especially hazardous substances or processes is proposed for which adequate
and accepted controls and safeguards are unknown or not available.
5. The proposed research may overload existing waste treatment plants due to new loads
(volume, chemicals, toxicity, additional hazardous wasted, etc.).
6. The proposed research may have a possible impact on endangered or threatened
species.
7. The proposed research may introduce new sources of hazardous/toxic wastes or require
storage of wastes pending new technology for safe disposal.
8. The proposed research may introduce new sources of radiation or radioactive materials.
9. Substantial and reasonable controversy exists about the environmental effects of the
proposed research.
4.b. If yes, please explain:
If you answered “Yes” to Question 4.a., you must provide an explanation here as to the actual or
potential impact of the proposed research on the environment. Your entry is limited to 55
characters.
4.c. If this project has an actual or potential impact on the environment, has an exemption been
authorized or an environmental assessment (EA) or environmental impact statement (EIS) been
performed? Yes/No.
This field is required if you answered “Yes” to Question 4.a. Check “Yes” or “No.”
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4.d. If yes, please explain:
Enter additional details about the EA or EIS here. Your entry is limited to 55 characters.
5. Is the research performance site designated, or eligible to be designated, as a
historic place?
This field is required.
If any research performance site is designated, or eligible to be designated, as a historic place,
check the “Yes” box. Otherwise, check “No.”
5.a. If yes, please explain:
If you checked “Yes” to indicate that any performance site is designated, or eligible to be
designated, as a historic place, provide the explanation here. Your entry is limited to 55
characters.
6. Does this project involve activities outside of the United States or partnerships
with international collaborators?
This field is required.
Indicate whether this project involves activities outside of the United States or partnerships with
international collaborators. Check “Yes” or “No.”
Applicants to NIH and other PHS agencies must check “Yes” if the applicant organization is a
foreign institution or if the project includes a foreign component. See NIH Glossary for a
definition of a foreign component.
If you have checked “Yes” to Question 6, you must include a “Foreign Justification” attachment in
Field 12, Other Attachments. Describe special resources or characteristics of the research project
(e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why
the facilities or other aspects of the proposed project are more appropriate than a domestic
setting. In the body of the text, begin the section with a heading indicating “Foreign
Justification” and name the file “Foreign Justification.”
6.a. If yes, identify countries:
This field is required if you answered “Yes” to Question 6. Enter the countries with which
international cooperative activities are planned.
You may use abbreviations. Your entry is limited to 55 characters.
6.b. Optional Explanation:
This field is optional. Enter an explanation for involvement with outside entities. Your entry is
limited to 55 characters.
7. Project Summary/Abstract
The "Project Summary/Abstract" attachment is required.
The project summary is a succinct and accurate description of the proposed work and should be
able to stand on its own (separate from the application). This section should be informative to
other persons working in the same or related fields and understandable to a scientifically literate
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reader. Avoid both descriptions of past accomplishments and the use of the first person. Please
be concise.
Format:
This section is limited to 30 lines of text, and must follow the required font and margin
specifications. A summary that exceeds the 30-line limit will be flagged as an error by the Agency
upon submission.
Attach this information as a PDF file. See the Format Attachments page.
Content:
State the application's broad, long-term objectives and specific aims, making reference to the
health relatedness of the project (i.e., relevance to the mission of the agency). Describe the
research design and methods for achieving the stated goals. Be sure that the project summary
reflects the key focus of the proposed project so that the application can be appropriately
categorized.
Do not include proprietary, confidential information or trade secrets in the project summary. If
the application is funded, the project summary will be entered into an NIH database and made
available on the NIH Research Portfolio Online Reporting Tool (RePORT) and will become public
information.
Note that the "Project Summary/Abstract" attachment is not same as the "Research Strategy"
attachment.
Additional Instructions for Career Development:
In addition to summarizing the research project to be conducted under the career
development award, describe the candidate’s career development plan, the
candidate’s career goals, and the environment in which the career development will
take place. The entire “Project Summary/Abstract” attachment is limited to 30 lines
of text.
8. Project Narrative
The "Project Narrative" attachment is required.
Content:
Describe the relevance of this research to public health in, at most, three sentences. For example,
NIH applicants can describe how, in the short or long term, the research would contribute to
fundamental knowledge about the nature and behavior of living systems and/or the application
of that knowledge to enhance health, lengthen life, and reduce illness and disability. If the
application is funded, this public health relevance statement will be combined with the project
summary (above) and will become public information.
9. Bibliography & References Cited
Who must complete the “Bibliography & References Cited” attachment:
The “Bibliography & References Cited” attachment is required unless otherwise noted in the
FOA.
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K.220 - R&R Other Project Information Form
Format:
Attach this information as a PDF file. See the Format Attachments page.
Content:
See the following instructions for which references to include in the “Bibliography and
References Cited” attachment.
Additional Instructions for Career Development:
The “Bibliography & References Cited” attachment should include any references
cited in K.410 - PHS 398 Career Development Award Supplemental Form and in the
K.500 - PHS Human Subjects and Clinical Trials Information form.
When citing articles that fall under the Public Access Policy, were authored or co-authored by the
applicant, and arose from NIH support, provide the NIH Manuscript Submission reference
number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567)
for each article. If the PMCID is not yet available because the Journal submits articles directly to
PMC on behalf of their authors, indicate “PMC Journal – In Process.” NIHmaintains a list of such
journals.
Citations that are not covered by the Public Access Policy, but are publicly available in a free,
online format may include URLs or PubMed ID (PMID) numbers along with the full reference. The
references should be limited to relevant and current literature. While there is not a page
limitation, it is important to be concise and to select only those literature references pertinent to
the proposed research.
You are allowed to cite interim research products. Note: interim research products have specific
citation requirements. See related Frequently Asked Questions for more information.
10. Facilities & Other Resources
Format:
The “Facilities & Other Resources” attachment is required unless otherwise specified in the FOA.
Content:
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). In
describing the scientific environment in which the work will be done, discuss ways in which the
proposed studies will benefit from unique features of the scientific environment or from unique
subject populations or how studies will employ useful collaborative arrangements.
If there are multiple performance sites, describe the resources available at each site.
Describe any special facilities used for working with biohazards and any other potentially
dangerous substances. Note: Information about select agents must be described in the
Research Plan, Select Agent Research.
For early stage investigators (ESIs), describe institutional investment in the success of the
investigator. See NIH's New and Early Stage Investigator Policies. Your description may include
the following elements:
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K.220 - R&R Other Project Information Form
l resources for classes, travel, or training;
l collegial support, such as career enrichment programs, assistance and guidance in the
supervision of trainees involved with the ESI’s project, and availability of organized peer
groups;
l logistical support, such as administrative management and oversight and best practices
training;
l financial support, such as protected time for research with salary support.
Additional Instructions for Career Development:
Include a detailed description of the institutional facilities and resources available
to the candidate. The information provided is of major importance in establishing
the feasibility of the goals of the career development plan.
11. Equipment
The “Equipment” attachment is required.
Format:
Attach this information as a PDF file.
Content:
List major items of equipment already available for this project and, if appropriate, identify the
equipment's location and pertinent capabilities.
12. Other Attachments
Attach a file to provide additional information only in accordance with the FOA and/or agency-
specific instructions.
If applicable, attach a “Foreign Justification” here. (See Question 6 above).
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K.230 - Project/Performance Site Location(s) Form
K.230 - Project/Performance Site
Location(s) Form
The Project/Performance Site Location(s) Form is used
for all grant applications. It is used to report the primary
location and any other locations at which the project
will be performed.
View larger image
Quick Links
Project/Performance Site Primary Location
Project/Performance Site Location 1
Additional Location(s)
Using the Project/Performance Site Location(s) Form:
This form allows for the collection of multiple performance sites. If you need to add more
project/performance site locations than the form allows, enter the information in a separate file and
add it to the “Additional Locations” section.
Project/Performance Site Primary Location
Generally, the primary location should be that of the applicant organization or identified as off-
site in accordance with the conditions of the applicant organization’s negotiated Facilities and
Administrative (F&A) agreement. This information must agree with the F&A information on the
budget form of the application.
Provide an explanation of resources available from each project/performance site on the
"Facilities and Resources" attachment of the K.220 - R&R Other Project Information Form.
If the proposed project involves human subjects or live vertebrate animals, it is up to the
applicant organization to ensure that all sites meet certain criteria:
Human Subjects: If a project/performance site is engaged in research involving human subjects,
the applicant organization is responsible for ensuring that the project/performance site operates
under an appropriate Federal Wide Assurance for the protection of human subjects and
complies with 45 CFR 46 and other NIH human subject related policies described in the NIH
Grants Policy Statement, Section 4.1.15: Human Subjects Protections.
Vertebrate Animals: For research involving live vertebrate animals, the applicant organization
must ensure that all project/performance sites hold an Office of Laboratory Animal Welfare
(OLAW)-approved Animal Welfare Assurance. If the animal work will be conducted at an
institution with an Animal Welfare Assurance and the applicant organization does not have the
following:
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K.230 - Project/Performance Site Location(s) Form
l an animal care and use program;
l facilities to house animals and conduct research on site; and
l an IACUC;
then applicant must obtain an Inter-institutional Assurance from OLAW prior to an award.
Additional Instructions for Career Development:
Indicate where the work described in the Research and Career Development Plans
will be conducted. Include any foreign sites (if applicable). If there is more than one
site, including any Department of Veterans Affairs (VA) facilities or foreign sites, list
them all in the fields provided for Location 1, and additional locations, as necessary.
Describe any consortium/contractual arrangements in the
"Consortium/Contractual Arrangements" attachment in K.410 – PHS 398 Career
Development Award Supplemental Form.
“I am submitting an application as an individual, and not on behalf of a company, state, local or
tribal government, academia, or other type of organization”:
Do not check the box for “I am submitting an application as an individual, and not on behalf of a
company, state, local or tribal government, academia, or other type of organization” unless
otherwise specified by the FOA.
Organization Name:
This field is required. Enter the organization name of the primary site where the work will be
performed.
DUNS Number:
This field is required for the primary performance site.
Enter the DUNS or DUNS+4 number associated with the organization where the project will be
performed.
Street1:
This field is required. Enter the first line of the street address of the primary performance site
location.
Street2:
Enter the second line of the street address of the primary performance site location.
City:
This field is required. Enter the city for the address of the primary performance site location.
County:
Enter the county of the primary performance site location.
State:
This field is required if the site is located in the United States or its Territories. Enter the state or
territory where the primary performance site is located.
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K.230 - Project/Performance Site Location(s) Form
Province:
If “Country" is Canada, enter the province for the primary performance site; otherwise, skip the
“Province” field.
Country:
This field is required. Select the country of the address for the primary performance site location.
ZIP/Postal Code:
The ZIP+4 is required if the primary performance site location is in the United States. Otherwise,
the postal code is optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the primary
performance site.
Project/Performance Site Congressional District:
Enter the Congressional District as follows: a 2-character state abbreviation, a hyphen, and a 3-
character district number. Examples: CA-005 for California’s 5th district, VA-008 for Virginia’s 8th
district.
It is likely this field will be identical to the “Congressional District of Applicant” field provided
elsewhere in the application.
If the program/project is outside the United States, enter 00-000.
For States and U.S. territories with only a single congressional district, enter “001” for the district
number.
For jurisdictions with no representative, enter “099.”
For jurisdictions with a nonvoting delegate, enter “098” for the district number. Example: DC-098
or PR-098.
If all districts in a state are affected, enter “all” for the district number. Example: "MD-all" for all
congressional districts in Maryland.
If nationwide (all districts in all states), enter "US-all."
If you do not know the Congressional District: Go to the United States House of
Representatives website and search for the Congressional District by entering the ZIP+4. If you
do not know the ZIP+4, look it up on the USPS Look Up Zip Code website.
Project/Performance Site Location 1
Use this “Project/Performance Site Location 1” block to provide information on performance sites
in addition to the Primary Performance Site listed above, if applicable. Include any VA facilities and
foreign sites.
Organization Name:
Enter the organization name of the performance site location.
DUNS Number:
Enter the DUNS or DUNS+4 number associated with the performance site.
Street1:
This field is required. Enter first line of the street address of the performance site location.
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Street2:
Enter the second line of the street address of the performance site location.
City:
This field is required. Enter the city for the address of the performance site location.
County:
Enter the county of the performance site location.
State:
This field is required if the project performance site is located in the United States or its
Territories. Enter the state or territory where the performance site is located.
Province:
If “Country” is Canada, enter the province for the performance site; otherwise, skip the “Province”
field.
Country:
This field is required. Select the country of the performance site location.
ZIP/Postal Code:
The ZIP+4 is required if the performance site location is in the United States. Otherwise, the
postal code is optional. Enter the ZIP+4 (nine-digit postal code) of the performance site location.
Project/Performance Site Congressional District:
Enter the Congressional District as follows: a 2-character state abbreviation, a hyphen, and a 3-
character district number. Examples: CA-005 for California’s 5th district, VA-008 for Virginia’s 8th
district.
If the program/project is outside the United States, enter 00-000.
For States and U.S. territories with only a single congressional district enter “001” for the district
number.
For jurisdictions with no representative, enter “099.”
For jurisdictions with a nonvoting delegate, enter “098” for the district number. Example: DC-098
or PR-098.
If all districts in a state are affected, enter “all” for the district number. Example: "MD-all" (for all
congressional districts in Maryland).
If nationwide (all districts in all states), enter "US-all."
If you do not know the Congressional District: Go to the United States House of
Representatives website and search for your Congressional District by entering your ZIP+4. If you
do not know the ZIP+4 look it up on the USPS Look Up Zip Code website.
Additional Location(s)
If you need to add more project/performance site locations than the form allows, enter the
information in a separate file and add it to the “Additional Locations” section.
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K.240 - R&R Senior/Key Person Profile
(Expanded) Form
The R&R Senior/Key Person Profile (Expanded) Form is
used for all grant applications, and allows the collection
of data for all senior/key persons associated with the
project. Some information for the PD/PI may be pre-
populated from the SF424 (R&R) form. See instructions in
K.200 - SF 424 (R&R) Form if these fields are empty.
View larger image
Quick Links
Profile - Project Director/Principal Investigator
Instructions for a Biographical Sketch
Profile - Senior/Key Person
Additional Senior/Key Person Profile(s)
Using the R&R Senior/Key Person Profile (Expanded) Form
This form allows for the data collection for a PD/PI and up to 99 other senior/key individuals (including
any multi-PD/PIs). After the first 100 individuals have been entered, use the “Additional Senior/Key
Person Profiles Format Page” to attach any remaining data.
To ensure proper performance of this form, save your work frequently.
Who qualifies as a Senior/Key Person?
Unless otherwise specified in a FOA, senior/key personnel are defined as all individuals who contribute
in a substantive, meaningful way to the scientific development or execution of the project, whether or
not salaries are requested. Consultants should be included in this “Senior/Key Person Profile
(Expanded)” Form if they meet this definition.
List individuals that meet the definition of senior/key regardless of what organization they work for.
Profile - Project Director/Principal Investigator
Enter data in this “Profile – Project Director/Principal Investigator” section for the Project
Director/Principal Investigator (PD/PI).
The PD/PI must have an eRA Commons account with the PI role, and the account must be
affiliated with the applicant organization. If you are proposing research at an institute other than
the one you are currently at, do not create a separate Commons account with the proposed
applicant organization. For information on eRA Commons account administration, see the eRA
Account Management System’s Online Help.
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Special Instructions for Multiple PD/PIs: When submitting an application involving multiple
PD/PIs, list the “Contact” PD/PI in this field. List all additional PD/PIs in the Senior/Key Person
section(s) below.
Additional Instructions for Career Development:
For all career development award applications, the candidate is considered the
PD/PI. Therefore, the candidate must have an eRA Commons account with the PI
role and the account must be affiliated with the applicant organization. For
additional information on eRA Commons account administration, see the eRA
Account Management System’s Online Help.
If your proposed career development award will be at a different site than your
current institution, the proposed sponsoring institution will be the applicant
organization. You must affiliate your Commons account with that institution so
that you have access to records submitted on your behalf. Do not create a separate
Commons account with the proposed sponsoring institution.
Note that “multiple PD/PIs” are not applicable to career development award
applications, so do not use the PD/PI role for any other senior/key personnel.
Prefix:
This field may be pre-populated from the SF 424 (R&R) and reflects the prefix, if applicable, for the
name of the PD/PI.
First Name:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the first
(given) name of the PD/PI.
Middle Name:
This field may be pre-populated from the SF 424 (R&R) and reflects the middle name of the PD/PI.
Last Name:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the last
(family) name of the PD/PI.
Suffix:
This field may be pre-populated from the SF 424 (R&R) and reflects the suffix for the name of the
PD/PI.
Position/Title:
This field may be pre-populated from the SF 424 (R&R) and reflects the position/title of the PD/PI.
Department:
This field may be pre-populated from the SF 424 (R&R) and reflects the name of the primary
organizational department, service, laboratory, or equivalent level within the organization of the
PD/PI.
Organization Name:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the
name of the organization of the PD/PI.
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Division:
This field may be pre-populated from the SF 424 (R&R) and reflects the name of the primary
organizational division, office, major subdivision, or equivalent level within the organization of
the PD/PI.
Street1:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the first
line of the street address for the PD/PI.
Street2:
This field may be pre-populated from the SF 424 (R&R) and reflects the second line of the street
address for the PD/PI.
City:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the city
for the address of the PD/PI.
County/Parish:
This field may be pre-populated from the SF 424 (R&R) and reflects the county/parish for the
address of the PD/PI.
State:
This field is required if the PD/PI is located in the United States or its Territories. This field may be
pre-populated from the SF 424 (R&R) and reflects the state or territory in which the PD/PI is
located.
Province:
If “Country” is Canada, enter the province for the PD/PI; otherwise, skip the “Province” field. This
field may be pre-populated from the SF 424 (R&R) and reflects the province in which the PD/PI is
located.
Country:
This field may be pre-populated from the SF 424 (R&R) and reflects the country for the address of
the PD/PI.
ZIP/Postal Code:
The ZIP+4 is required if the PD/PI address is in the United States. Otherwise, the postal code is
optional. This field may be pre-populated from the SF 424 (R&R) and reflects the postal code of
the address of the PD/PI.
Phone Number:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the
daytime phone number for the PD/PI.
Fax Number:
This field may be pre-populated from the SF 424 (R&R) and reflects the fax number for the PD/PI.
E-mail:
This field is required. This field may be pre-populated from the SF 424 (R&R) and reflects the e-
mail address for the PD/PI.
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Credential, e.g., agency login:
This field is required. Enter the assigned eRA Commons username for the project’s PD/PI. The eRA
Commons username must hold the PI role and be affiliated with the applicant organization.
Applications will not pass agency validation requirements without a valid eRA Commons
username.
Special Instructions for Multiple PD/PI: The Commons username must be provided for
all individuals assigned the Project Role of PD/PI on the application.
Additional Instructions for Career Development:
Enter the eRA Commons username for the PD/PI (Career Development
candidate). The eRA Commons Personal Profile associated with the username
entered in the Credential field must include an ORCID ID. For more information on
linking an ORCID ID to an eRA Commons Personal Profile, see the ORCID ID topic in
the eRA Commons online help.
Project Role:
Enter "PD/PI" for the Project Role for the PD/PI.
Other Project Role Category:
Skip the “Other Project Role Category” field, as no other role can be added to the PD/PI role.
Degree Type:
Enter the highest academic or professional degree or other credentials (e.g., R.N.).
Degree Year:
Enter the year the highest degree or other credential was obtained.
Attach Biographical Sketch
Provide a biographical sketch for each PD/PI. See instructions below on how to complete a
biographical sketch.
Attach Current & Pending Support:
Do not use this attachment upload for NIH and other PHS agency submissions unless otherwise
specified in the FOA.
While this information is not required at the time of application submission, it may be requested
later in the pre-award cycle. If and when this occurs, refer to the NIH Grants Policy Statement,
Section 2.5.1: Just-in-Time Procedures.
Instructions for a Biographical Sketch
These instructions apply to Research (R), Career Development (K), Training (T), Fellowship (F),
Multi-project (M), and SBIR/STTR (B).
Who must complete the “Biographical Sketch” section:
All senior/key personnel and other significant contributors (OSCs) must include biographical
sketches (biosketches).
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Format:
Use the sample format on the Biographical Sketch Format Page to prepare this section for all
grant applications.
Figures, tables (other than those included in the provided format pages), or graphics are not
allowed in the biosketch. Do not embed or attach files (e.g. video, graphics, sound, data).
The biosketch may not exceed five pages per person. This five-page limit includes the table at the
top of the first page.
Attach this information as a PDFfile. See the Format Attachments page.
Content:
Note that the instructions here follow the format of Biographical Sketch Format Page.
Name:
Fill in the name of the senior/key person or other significant contributor in the “Name” field of
the Biosketch Format Page.
eRA Commons User Name:
If the individual is registered in the eRA Commons, fill in the eRA Commons User Name in the
“eRA Commons User Name” field of the Biosketch Format Page.
The “eRA Commons User Name” field is required for the PD/PI (including career development and
fellowship applicants), primary sponsors of fellowship applicants, all mentors of candidates for
mentored career development awards, and candidates for diversity and reentry research
supplements.
The “eRA Commons User Name” field is optional for other project personnel.
The eRA Commons User Name should match the information provided in the Credential
field of the R&R Senior/Key Person Profile (Expanded) Form in your grant application.
Position Title:
Fill in the position title of the senior/key person or other significant contributor in the “Position
Title” field of the Biosketch Format Page.
Education/Training
Complete the education block. Begin with the baccalaureate or other initial professional
education, such as nursing. Include postdoctoral, residency, and clinical fellowship training, as
applicable, listing each separately.
For each entry provide:
l the name and location of the institution
l the degree received (if applicable)
l the month and year of end date (or expected end date). For fellowship applicants only,
also include the month and year of start date.
l the field of study (for residency entries, the field of study should reflect the area of
residency training)
Following the education block, complete Sections A-D of the biographical sketch.
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A. Personal Statement
Briefly describe why you are well-suited for your role(s) in this project. Relevant factors may
include: aspects of your training; your previous experimental work on this specific topic or related
topics; your technical expertise; your collaborators or scientific environment; and/or your past
performance in this or related fields.
You may cite up to four publications or research products that highlight your experience and
qualifications for this project. Research products can include, but are not limited to, audio or
video products; conference proceedings such as meeting abstracts, posters, or other
presentations; patents; data and research materials; databases; educational aids or curricula;
instruments or equipment; models; protocols; and software or netware.
You are allowed to cite interim research products. Note: interim research products have specific
citation requirements. See related Frequently Asked Questions for more information.
Note the following additional instructions for ALL applicants/candidates:
l If you wish to explain factors that affected your past productivity, such as family care
responsibilities, illness, disability, or military service, you may address them in this “A.
Personal Statement” section.
l Indicate whether you have published or created research products under another name.
l You may mention specific contributions to science that are not included in Section C. Do
not present or expand on materials that should be described in other sections of this
Biosketch or application.
l Figures, tables, or graphics are not allowed.
Note the following instructions for specific subsets of applicants/candidates:
l For institutional research training, institutional career development, or research
education grant applications, faculty who are not senior/key persons are encouraged,
but not required, to complete the "A. Personal Statement" section.
l Applicants for dissertation research awards (e.g., R36) should, in addition to addressing
the points noted above, also include a description of their career goals, their intended
career trajectory, and their interest in the specific areas of research designated in the
FOA.
l Candidates for research supplements to promote diversity in health-related research
should, in addition to addressing the points noted above, also include a description of
their general scientific achievements and/or interests, specific research objectives, and
career goals. Indicate any current source(s) of educational funding.
B. Positions and Honors
List in chronological order the positions you’ve held that are relevant to this application,
concluding with your present position. High school students and undergraduates may include
any previous positions. For individuals who are not currently located at the applicant
organization, include the expected position at the applicant organization and the expected start
date.
List any relevant academic and professional achievements and honors. In particular:
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l Students, postdoctorates, and junior faculty should include scholarships, traineeships,
fellowships, and development awards, as applicable.
l Clinicians should include information on any clinical licensures and specialty board
certifications that they have achieved.
C. Contributions to Science
Who should complete the “Contributions to Science” section:
All senior/key persons should complete the “Contributions to Science” section except candidates
for research supplements to promote diversity in health-related research who are high school
students, undergraduates, and post-baccalaureates.
Format:
Briefly describe up to five of your most significant contributions to science. The description of
each contribution should be no longer than one half page, including citations.
While all applicants may describe up to five contributions, graduate students and postdoctorates
may wish to consider highlighting two or three they consider most significant.
Content:
For each contribution, indicate the following:
l the historical background that frames the scientific problem;
l the central finding(s);
l the influence of the finding(s) on the progress of science or the application of those
finding(s) to health or technology; and
l your specific role in the described work.
For each contribution, you may cite up to four publications or research products that are
relevant to the contribution. If you are not the author of the product, indicate what your role or
contribution was. Note that while you may mention manuscripts that have not yet been accepted
for publication as part of your contribution, you may cite only published papers to support each
contribution. Research products can include audio or video products (see the NIH Grants Policy
Statement, Section 2.3.7.7: Post-Submission Grant Application Materials); conference
proceedings such as meeting abstracts, posters, or other presentations; patents; data and
research materials; databases; educational aids or curricula; instruments or equipment; models;
protocols; and software or netware.
You are allowed to cite interim research products. Note: interim research products have specific
citation requirements. See related Frequently Asked Questions for more information.
You may provide a URL to a full list of your published work. This URL must be to a Federal
Government website (a .gov suffix). NIH recommends using My Bibliography. Providing a URL to a
list of published work is not required.
Descriptions of contributions may include a mention of research products under development,
such as manuscripts that have not yet been accepted for publication. These contributions do not
have to be related to the project proposed in this application.
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D. Additional Information: Research Support and/or Scholastic Performance
Note the following instructions for specific subsets of applicants/candidates:
l High school students are not required to complete Section D. Additional Information:
Research Support and/or Scholastic Performance.
l Career development award applicants should complete the "Research Support" section
but skip the “Scholastic Performance” section.
l Generally, the following types of applicants can skip the “Research Support” section and
must complete only the “Scholastic Performance” section. However, when these
applicants also have Research Support, they may complete both sections.
o
applicants for predoctoral and postdoctoral fellowships
o
applicants to dissertation research grants (e.g., R36)
o
candidates for research supplements to promote diversity in health-related research
from the undergraduate through postdoctoral levels
Research Support
These instructions apply to all applicants who are completing the “Research Support” section.
List ongoing and completed research projects from the past three years that you want to draw
attention to. Briefly indicate the overall goals of the projects and your responsibilities. Do not
include the number of person months or direct costs.
Do not confuse “Research Support” with “Other Support.” Other Support information is not
collected at the time of application submission.
l Research Support: As part of the Biosketch section of the application, “Research
Support” highlights your accomplishments, and those of your colleagues, as scientists.
This information will be used by the reviewers in the assessment of each your
qualifications for a specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team.
l Other Support: NIH staff may request complete and up-to-date “other support”
information from you as part of Just-in-Time information collection.
Scholastic Performance
Predoctoral applicants/candidates (including undergraduates and post-baccalaureates): List
by institution and year all undergraduate and graduate courses, with grades. In addition, 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.
Also indicate the levels required for a passing grade.
Postdoctoral applicants: List by institution and year all graduate scientific and/or professional
courses with grades. In addition, 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. Also indicate the levels required for a passing grade.
Profile – Senior/Key Person 1
Enter data in this “Profile – Senior/Key Person 1” section to provide information on a senior/key
person (other than the PD/PI listed above), if applicable.
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Format:
List all senior/key person profiles, followed by other significant contributors (OSC) profiles.
Content – Who to include in the “Profile – Senior/Key Person” section:
Senior/Key Persons: Fill in a separate “Profile – Senior/Key Person” block for each senior/key
personnel. Those with a postdoctoral role should be included if they meet the NIH Glossary
definition of senior/key personnel. A biosketch is required for all senior/key persons.
Other Significant Contributors: Also use the “Profile – Senior/Key Person” section to list any
other significant contributors (OSCs). Consultants should be included if they meet the NIH
Glossary definition of OSC. OSCs should be listed after all other senior/key persons.
A biosketch is required for all OSCs. The biosketch should highlight the OSC’s accomplishments
as a scientist. Reviewers assess these pages during peer review. For more information on review
criteria, see the Review Criteria at a Glance document. Although Other Support information is
required as a just-in-time submission, Other Support information will NOT be required or
accepted for OSCs since considerations of overlap do not apply to these individuals.
Should the level of involvement increase for an individual listed as an OSC, thus requiring
measurable effort on the award, the individual must be redesignated as “senior/key personnel.”
This change must be made before any compensation is charged to the project.
For more information:
For more information, refer to these NIHSenior/Key Personnel Frequently Asked Questions.
Additional Instructions for Career Development:
Who to include in the “Profile – Senior/Key Person” information section:
Mentored career development awards require a primary mentor, and there may
also be co-mentor(s). Mentors and co-mentors, should be identified as senior/key
personnel, even if they are not committing any specified measurable effort to the
proposed project, and they must provide an eRA Commons username.
In addition to involving mentor(s), applications may also involve collaborators,
consultants, and advisory committee members. These individuals are usually not
considered senior/key personnel unless they contribute in a substantive,
meaningful way to the career development of the candidate or the career
development project. In determining which individuals to identify as “Senior/Key,”
mentored career development award applicants may wish to keep in mind that
those listed as senior/key personnel on the application should not be asked to
provide reference letters, as such letters are expected to be from individuals not
directly involved in the application. For more information, see NIH's Reference
Letters page.
Prefix:
Enter or select the prefix, if applicable, for the name of the senior/key person.
First Name:
This field is required. Enter the first (given) name of the senior/key person.
Middle Name:
Enter the middle name of the senior/key person.
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Last Name:
This field is required. Enter the last (family) name of the senior/key person.
Suffix:
Enter or select the suffix, if applicable, for the senior/key person.
Position/Title:
Enter the position/title of the senior/key person.
Department:
Enter the name of the primary organizational department, service, laboratory, or equivalent level
within the organization of the senior/key person.
Organization Name:
This field is required. Enter the name of the organization of the senior/key person.
Division:
Enter the name of the primary organizational division, office, major subdivision, or equivalent
level within the organization of the senior/key person.
Street1:
This field is required. Enter the first line of the street address for the senior/key person.
Street2:
Enter the second line of the street address for the senior/key person.
City:
This field is required. Enter the city for the address of the senior/key person.
County/Parish:
Enter the county/parish for the address of the senior/key person.
State:
This field is required if the Senior/Key person is located in the United States or its Territories.
Enter the state or territory where the senior/key person is located.
Province:
If “Country” is Canada, enter the province for the senior/key person; otherwise, skip the
“Province” field.
Country:
This field is required. Select the country for the address of the senior/key Person.
ZIP/Postal Code:
The ZIP+4 is required if the Senior/Key Person is in the United States. Otherwise, the postal code
is optional. Enter the ZIP+4 (nine-digit postal code) or postal code of the senior/key person.
Phone Number:
This field is required. Enter the daytime phone number for the senior/key person.
Fax Number:
Enter the fax number for the senior/key person.
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E-mail:
This field is required. Enter the e-mail address for the senior/key person.
Credential, e.g., agency login:
If you have an established eRA Commons personal profile, enter the senior/key person's
username. If you do not have an eRA Commons personal profile, skip the “Credential” field.
Additional Instructions for Career Development:
For senior/key person who are the primary mentor, an eRA Commons username
must be provided in the “Credential” field. For more information, see the NIH Guide
Notice on eRA Commons Username Requirements for Primary Mentors.
Project Role:
Select a project role. Use "Other (Specify)" if the desired category is not available.
Special Instructions for Multiple PD/PIs:All PD/PIs must be assigned the “PD/PI” role,
even those at organizations other than the applicant organization. The role of “Co-PD/PI”
is not currently used by NIH or other PHS agencies to designate a multiple PD/PI
application. In order to avoid confusion, do not use the role of “Co-PD/PI.”
Note on OSCs: For OSCs, enter “Other (Specify)” for the “Project Role” field, and enter “Other
Significant Contributor” in the “Other Project Role Category” field.
Additional Instructions for Career Development:
For mentors and co-mentors, enter “Other Professional” for the “Project Role” field,
and enter “Mentor” or “Co-mentor” as applicable in the “Other Project Role
Category” field.
“Multiple PD/PIs” are not applicable to career development applications. The PD/PI
role must be used only for the candidate and not for any other senior/key
personnel.
Other Project Role Category:
Complete this field (e.g., Engineer, Chemist, Sponsor, Mentor) if you selected “Other Professional”
or “Other (Specify)” in the “Project Role” field.
Degree Type:
Enter the highest academic or professional degree or other credentials (e.g., R.N.).
Degree Year:
Enter the year the highest degree or other credential was obtained.
Attach Biographical Sketch:
Provide a biographical sketch for each senior/key person and each OSC. See instructions above
on how to complete a biographical sketch.
Attach Current & Pending Support:
Note: The terms “current and pending support,” “other support,” and “active and pending
support” are used interchangeably.
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Do not use the "Current &Pending Support" attachment upload for NIH or other PHS agency
submissions unless otherwise specified in the FOA (see exception for career development
applications in the Career Development-specific instructions below).
While this information is not required at the time of application submission, it may be requested
later in the pre-award cycle. If and when this occurs, refer to the NIH Grants Policy Statement,
Section 2.5.1: Just-in-Time Procedures for instructions and use the Current and Pending Support
Format Page.
Additional Instructions for Career Development:
Who must complete the “Current & Pending Support” field:
For mentored career development award applications, you must include "Current
and Pending Support" pages for each of the mentor and co-mentor(s). You do not
need to include "Current and Pending Support" pages for the candidate.
Format:
Attach this information as a PDF. See the Format Attachments page.
See also the Current and Pending Support Format Page.
Content:
Provide information on the following items for each of the mentor’s and co-
mentor’s current and pending research support relevant to the candidate’s
research plan. Each mentor/co-mentor(s)’s “Current & Pending Support”
attachment is limited to 3 pages.
Project Number: If applicable, include a code or identifier for the project.
Source: Identify the agency, institute, foundation, or other organization that is
providing the support.
Major Goals: Provide a brief statement of the overall objectives of the project,
subproject, or subcontract.
Dates of Approved/Proposed Project: Indicate the inclusive dates of the
project as approved/proposed. For example, in the case of NIH support,
provide the dates of the approved/proposed competitive segment.
Annual Direct Costs: In the case of an active project, provide the current year’s
direct cost budget. For a pending project, provide the proposed direct cost
budget for the initial budget period.
Do not include information on “percent effort/person months” or on “overlap.”
For more Information:
For more information on “Other Support Information,” see the NIH Grants Policy
Statement, Section 2.5.1: Just-in-Time Procedures.
Additional Senior/Key Person Profile(s)
If you need to add more Senior/Key Person Profiles than the form allows, enter the information in
a separate file and attach it as a PDF.
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K.300 - R&R Budget Form
K.300 - R&R Budget Form
The R&R Budget Form is used in the majority of
applications; however, it is important to refer to your
specific FOA for guidance on which budget form(s) are
allowed for your application.
Some application forms packages include two optional
budget forms — (1) the R&R Budget Form and, (2) PHS
398 Modular Budget Form. Include only one of these
forms, but not both, in your application.
View larger image
Quick Links
Introductory Fields
A. Senior/Key Person
B. Other Personnel
C. Equipment Description
D. Travel
E. Participant/Trainee Support Costs
F. Other Direct Costs
G. Direct Costs
H. Indirect Costs
I. Total Direct and Indirect Costs
J. Fee
K. Total Costs and Fee
L. Budget Justification
Research & Related Budget - Cumulative Budget
Who should use the R&R Budget Form?
There are two primary types of Budget Forms: detailed R&R and PHS 398 modular. Generally, you must
use the R&R Budget Form if you are applying for more than $250,000 per budget period in direct
costs, and you must use the Modular Budget Form if you are applying for less than $250,000. However,
some grant mechanisms or programs (e.g., training grants) may require other budget forms to be
used. Refer to your FOA and to the following instructions for guidance on which Budget Form to use.
Note: The terms “detailed budget” and “R&R Budget” are used interchangeably.
If you are requesting a budget with $500,000 or more in direct costs for any budget period, contact
the awarding component to determine whether you must obtain prior approval before submitting the
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application. For more information on applications that request $500,000 or more in direct costs, see
the NIH Grants Policy Statement, Section 2.3.7.2: Acceptance for Review of Unsolicited Applications
Requesting $500,000 or More in Direct Costs.
Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): All
competing (new, renewal, resubmission, and revision) grant applications from foreign (non-U.S.)
institutions must use the R&R Budget Form. Do not use the PHS 398 Modular Budget Form. For
additional information, see NIH Guide Notice on the Requirement for Detailed Budget Submissions
from Foreign Institutions and the NIH Grants Policy Statement, Section 13.3.1: Budget. Applications
from foreign organizations must request budgets in U.S. dollars.
Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use of
human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy
Statement) is included in the proposed application, you must use the R&R Budget Form and
cannot use the PHS Modular Budget Form, regardless of the activity code. Whether or not you incur
costs to obtain HFT, you will need to include a “Human Fetal Tissues Costs” line item (F.8-10) and a
Budget Justification attachment (L).
Note on Subawards/Consortiums: If you have a subaward/consortium, you must use the R&R
Subaward Budget Attachment(s) Form in conjunction with the R&R Budget Form. The prime must
extract the R&R Subaward Budget Attachment(s) from the R&R Subaward Budget Attachment(s)
Form and send the extracted file to the subaward/consortium. The consortium should complete the
R&R Subaward Budget Attachment, following the instructions here and in K.310 – R&R Subaward
Budget Attachment(s) Form.
For more information:
For more information on how to prepare your budget, see NIH's Develop Your Budget page.
Additional Instructions for Career Development:
Who should use the R&R Budget Form?
All career development applications must use the R&R Budget Form. The PHS 398
Modular Budget Form is not permissible.
Refer to your FOA for information regarding allowable costs for the candidate and
any allowable research development or other costs. Contact the targeted awarding
component if you are uncertain about allowable amounts for the applicable career
development award mechanism. Keep in mind that amounts vary with awarding
components.
Transitional Career Award applications: NIH intramural candidates applying for
transitional career award support (e.g., K22, K99/R00) should follow instructions in
the applicable FOA. For the mentored phase of these awards, budgets are
negotiated with the sponsoring intramural laboratory. For awardees who receive
approval to transition to the extramural phase, a budget will be required as part of
the extramural sponsored application.
Using the R&R Budget Form:
The location of the R&R Budget Form may vary with the type of submission (e.g., under an “Optional
Forms” tab).
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You must complete a separate detailed budget for each budget period requested. The form will
generate a cumulative budget for the total project period. If no funds are requested for a required
field, enter “0.”
You must round to the nearest whole dollar amount in all dollar fields.
Competing Revision Applications: For a supplemental/revision application, complete fields for which
additional funds are requested in addition to all required fields. If the initial budget period of the
supplemental/revision application is less than 12 months, prorate the personnel costs and other
appropriate items of the detailed budget.
Introductory Fields
Organizational DUNS:
This field is required. This field may be pre-populated and should reflect the DUNS or DUNS+4
number of the applicant organization (or of the lead organization for the component of a multi-
project application).
Enter name of Organization:
This field may be pre-populated. Enter the name of the organization.
Budget Type:
This field is required. Check the appropriate box for your budget type, following these guidelines:
l Project: The budget being requested is for the primary applicant organization.
l Subaward/Consortium: The budget being requested is for subaward/consortium
organization(s). Note, separate budgets are required only for subaward/consortium
organizations that perform a substantive portion of the project. For
subawards/consortiums that do not perform a substantive portion of the project, then
you must include their costs in Field F5. Subawards/Consortium/Contractual Costs and
in the prime’s Section L. Budget Justification.
If you are preparing an application that includes a subaward/consortium that performs a
substantive portion of the project, in addition to completing this form, see also the instructions
for K.310 - R&R Subaward Budget Attachment(s) Form.
Budget Period:
This field is required.
Identify the specific budget period (for example, 1, 2, 3, 4, 5).
Start Date:
This field is required and may be pre-populated from the SF 424 R&R Form. Enter the
requested/proposed start date of the budget period. For period 1, the start date is typically the
same date as the Proposed Project Start Date on the K.200 - SF 424 (R&R) Form.
End Date:
This field is required. Enter the requested/proposed end date of the budget period.
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A. Senior/Key Person
Who to include in A. Senior/Key Person:
Include the names of senior/key persons at the applicant organization, (or organization leading
the component of a multi-project application), who are involved on the project in a particular
budget period. Include all collaborating investigators and other individuals who meet the
senior/key person definition if they are from the applicant organization.
Consultants designated as senior/key persons in the Senior/Key Person Profile Form can be
included in the "A. Senior/Key Person" section only if they are also employees of the applicant
organization. Otherwise, consultant costs should be included in Consultant Services in Question
F of this form.
Who not to include in A. Senior/Key Person:
Do not list details of collaborators at other institutions here, as they will be provided in the
Subaward Budget for each subaward/consortium organization.
Personnel listed as other significant contributors who are not committing any specific
measurable effort to the project should not be included in the Personnel section (sections "A.
Senior/Key Person" and "B. Other Personnel") since no associated salary and/or fringe benefits
can be requested for their contribution.
Additional Instructions for Career Development:
Include information only for the candidate in the “A. Senior/Key Person" section. Do
not include the mentor(s) or any other senior/key persons. For the candidate,
provide the base salary, person months, and requested salary and fringe benefits.
career development programs include a minimum effort requirement, usually 75%
or nine person months.
Salary description: For the salary column, most NIH ICs limit the amount of salary
contribution provided for career development programs. However, applicants
should include information on actual institutional base salary and fringe benefits,
and the actual amount of salary and fringe being requested. ICs may request
updated salary information prior to award. Any adjustments based on policy
limitations will be made at the time of the award.
The total salary requested must be based on a full-time staff appointment. The
salary must be consistent both with the established salary structure at the
institution and with salaries actually provided by the institution from its own funds
to other staff of equivalent qualifications, rank, and responsibilities in the
department concerned. If full-time, 12-month salaries are not currently paid to
comparable staff members, the salary proposed must be appropriately related to
the existing salary structure. The total salary contribution provided by the NIH may
not exceed the legislatively mandated salary cap. See NIH's Salary Cap Summary.
Salary supplements: The sponsoring institution may supplement the NIH salary
contribution up to a level that is consistent with the institution's salary scale.
However, supplementation may not be from federal funds unless specifically
authorized by the federal program from which such funds are derived. In no case
may PHS funds be used for salary supplementation. Institutional supplementation
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of salary must not require extra duties or responsibilities that would interfere with
the purpose of the career award.
Prefix:
Enter the prefix (e.g., Mr., Mrs., Rev.), if applicable, for the name of the senior/key person.
First Name:
This field is required. Enter the first (given) name of the senior/key person.
Middle Name:
Enter the middle name of the senior/key person.
Last Name:
This field is required. Enter the last (family) name of the senior/key person.
Suffix:
Enter the suffix (e.g., Jr., Sr., PhD), if applicable, of the senior/key person.
Base Salary ($):
Enter the annual compensation paid by the employer for the senior/key person. This includes all
activities such as research, teaching, patient care, and other. An applicant organization may
choose to leave this blank; however, NIH or other PHS Agency staff will request this information
prior to award.
Months (Cal./Acad./Sum.):
NIH and other PHS agencies use the concept of “person months” as a metric for determining
percent of effort. For more information about calculating person months, see NIH's Frequently
Asked Questions on Person Months.
Identify the number of months the senior/key person will devote to the project in the applicable
box (i.e., calendar, academic, summer).
Use either calendar months OR a combination of academic and summer months. Measurable
effort is required for every senior/key person entry.
For an explanation of "measurable effort," see the Frequently Asked Questions on Senior/Key
Personnel.
If effort does not change throughout the year, it is OK to use only the calendar months column.
However, you may use both the academic and summer months columns if your institutional
business process requires noting each separately even if effort remains constant. If effort varies
between academic and summer months, leave the calendar months column blank and use only
the academic and summer months columns.
If your institution does not use a 9-month academic year or a 3-month summer period, indicate
your institution’s definition of these in Section L. Budget Justification.
Requested Salary ($):
This field is required. Regardless of the number of months being devoted to the project, indicate
the salary being requested for this budget period for the senior/key person.
Salary limitations. Some PHS grant programs are currently subject to a legislatively imposed
salary limitation. Any adjustment for salary limits will be made at the time of award; therefore,
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requested salary should be based on institutional base salary at the time the application is
submitted and not adjusted for any limitation. For guidance on current salary limitations, see the
NIH's Salary Cap Summary or contact your office of sponsored programs.
Graduate student compensation: NIH grants also limit compensation for graduate students.
Compensation includes salary or wages, fringe benefits, and tuition remission. While actual
institutional-based compensation should be requested and justified, this may be adjusted at the
time of the award. For more guidance on this policy, see the NIH Grants Policy Statement, Section
2.3.7.9: Graduate Student Compensation.
Fringe Benefits ($):
Enter the amount of requested fringe benefits, if applicable, for the senior/key person.
Funds Requested ($):
This field is automatically calculated and will reflect the total requested salary and fringe benefits
for the senior/key person.
Project Role:
This field is required. Identify the project role of each senior/key person. Roles should correspond
to the roles included on the K.240 - R&R Senior/Key Person Profile (Expanded) Form. Note that
there must be at least one PD/PI per budget period.
Additional Senior/Key Persons:
If you are requesting funds for more senior/key persons than the form allows, you must include
an attachment listing the additional senior/key person(s) in this “Additional Senior/Key Persons”
field. Use the same format as the budget form and include all the information identified in this
section.
Total Funds requested for all persons in the attached file:
If you have attached a file with additional senior/key persons, enter the total funds requested for
everyone listed in the attachment in the “Total Funds requested for all Senior/Key Persons in the
attached file” field.
Total Senior/Key Persons:
This total will be automatically calculated based on the sum of the “Funds Requested” column
and the “Total Funds requested for all Senior/Key Persons in the attached file” field.
Special Instructions for Joint University and Department of Veterans Affairs (V.A.)
Appointments: Individuals with joint university and V.A. appointments may request the university’s
share of their salary in proportion to the effort devoted to the research project. The individual’s
salary with the university determines the base for computing that request. The signature by the
institutional official on the application certifies that: (1) the individual is applying as part of a joint
appointment specified by a formal Memorandum of Understanding between the university and the
V.A.; and (2) there is no possibility of dual compensation for the same work, or of an actual or
apparent conflict of interest regarding such work. Additional information may be requested by the
awarding components.
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B. Other Personnel
Additional Instructions for Career Development:
Skip the "B. Other Personnel" section.
Number of Personnel:
For each project role category, identify the number of personnel proposed.
Administrative, Secretarial, and Clerical Support Salaries: In most circumstances, the salaries of
administrative, secretarial, or clerical staff at educational institutions and nonprofit organizations
are included as part of indirect costs (Section H. Indirect Costs). However, examples of situations
where direct charging of administrative or clerical staff salaries may be appropriate may be found
at: 45 CFR 75.403.
Inclusion of such costs may be appropriate only if all of the following conditions are met:
1. Administrative or clerical services are integral to a project or activity;
2. Individuals involved can be specifically identified with the project or activity;
3. Such costs are explicitly included in the budget or have prior written approval of the
federal awarding agency; and
4. The costs are not also recovered as indirect costs.
Requests for direct charging for secretarial/clerical personnel (i.e., administrative and clerical
staff) must be appropriately justified in Section L. Budget Justification. For all individuals classified
as administrative/secretarial/clerical, provide a justification (in the Budget Justification)
documenting how they meet all four conditions. NIH ICs may request additional information for
these positions in order to assess allowability.
Postdoctoral and Graduate Students: For all postdoctoral associates and graduate students not
already named in "Section A. Senior/Key Person," individually list names, roles (e.g., postdoctoral
associates or graduate student), associated months, and requested salary and fringe benefits in
Section L. Budget Justification.
Project Role:
List any additional project role(s) (e.g., engineer, IT professionals, etc.) in the blank(s) provided.
Identify the number of each personnel proposed.
You may have up to six named roles. If you have more than six, you must combine project roles
here and add an explanation about the named roles in Section L. Budget Justification.
Do not include consultants in this section. Consultants are included below in Section F. Other
Direct Costs.
Months (Cal./Acad./Sum.):
NIH and other PHS agencies use the concept of “person months” as a metric for determining
percent of effort. For more information about calculating person months, see: NIH's Frequently
Asked Questions on Person Months.
Identify the number of months devoted to the project in the applicable box (i.e., calendar,
academic, summer) for each project role category.
Use either calendar months OR a combination of academic and summer months.
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If effort does not change throughout the year, it is OK to use only the calendar months column.
However, you may use both academic and summer months columns if your institutional business
process requires noting each separately, even if effort remains constant. If effort varies between
academic and summer months, leave the calendar months column blank and use only the
academic and summer months columns.
If your institution does not use a 9-month academic year or a 3-month summer period, indicate
your institution’s definition of these in Section L. Budget Justification.
Requested Salary ($):
Regardless of the number of months being devoted to the project, indicate only the amount of
salary/wages being requested for this budget period for each project role. The amount entered
should reflect the total amount of funds requested for all personnel within a project role.
Salary limitations: Some PHS grant programs are currently subject to a legislatively imposed
salary limitation. Any adjustment for salary limits will be made at the time of award; therefore,
requested salary should be based on institutional base salary at the time the application is
submitted and not adjusted for any limitation. For guidance on current salary limitations, see the
NIH's Salary Cap Summary or contact your office of sponsored programs.
Graduate student compensation: NIH grants also limit the compensation for graduate students.
Compensation includes salary or wages, fringe benefits, and tuition remission. While actual
institutional-based compensation should be requested and justified, this may be adjusted at the
time of the award. For more guidance on this policy, see the NIH Grants Policy Statement, Section
2.3.7.9: Graduate Student Compensation.
Fringe Benefits ($):
Enter the amount of requested fringe benefits, if applicable, for this project role category. The
amount entered should reflect the total amount of fringe benefits requested for all personnel
within a project role.
Funds Requested ($):
This field will be automatically calculated and will reflect the total requested salary and fringe
benefits for each project role category.
Total Number of Other Personnel:
This total will be automatically calculated based on the Number of Personnel for each project role
category.
Total Other Personnel:
This total will be automatically calculated based on the sum of the Funds Requested for all Other
Personnel.
Total Salary, Wages and Fringe Benefits (A+B):
This total will be automatically calculated and represents the total Funds Requested for all
Senior/Key persons and all Other Personnel.
C. Equipment Description
The “C. Equipment Description” section is for you to list items and dollar amount for each item
exceeding $5,000 (unless the organization has established lower levels).
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Additional Instructions for Career Development:
Skip the “C. Equipment Description” section.
Equipment Item:
Equipment is defined as an item of property that has an acquisition cost of $5,000 or more
(unless the organization has established lower levels) and an expected service life of more than
one year.
List each item of equipment separately and justify each in Section L. Budget Justification.
Allowable items ordinarily will be limited to research equipment not already available for the
conduct of the work.
Funds Requested:
This information is required. List the estimated cost of each item, including shipping and any
maintenance costs and agreements.
Additional Equipment:
If you're requesting funds for more equipment than the form allows, you must include an
attachment listing the additional equipment items in this “Additional Equipment” field. Enter the
information in a separate file and attach it as a PDF. List each additional item and the funds
requested for each individual item. The dollar amount for each item should exceed $5,000 (unless
the organization has established lower levels).
Total funds requested for all equipment listed in the attached file:
If you have attached a file with additional equipment, enter the total funds requested for all the
equipment listed in the attachment.
Total Equipment:
This total will be automatically calculated based on the sum of the “Funds Requested” column
and the “Total funds requested for all equipment listed in the attached file” field.
D. Travel
Additional Instructions for Career Development:
Skip the "D. Travel" section.
1. Domestic Travel Costs (Incl. Canada, Mexico, and U.S. Possessions):
Enter the total funds requested for domestic travel. Domestic travel includes destinations in the
U.S., Canada, Mexico, and U.S. possessions. In Section L. Budget Justification, include the
purpose, destination, dates of travel (if known), and the number of individuals for each trip. If the
dates of travel are not known, specify the estimated length of trip (e.g., 3 days).
2. Foreign Travel Costs:
Identify the total funds requested for foreign travel. Foreign travel includes any destination
outside of the U.S., Canada, Mexico, or U.S. possessions. In Section L. Budget Justification, include
the purpose, destination, dates of travel (if known), and the number of individuals for each trip. If
the dates of travel are not known, specify the estimated length of trip (e.g., 3 days).
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Total Travel Cost:
This total will be automatically calculated based on the sum of the Domestic and Foreign Funds
Requested fields.
E. Participant/Trainee Support Costs
Unless specifically stated otherwise in a FOA, NIH and other PHS agencies applicants should skip
Section E. Participant/Trainee Support Costs. Note: Tuition remission for graduate students
should be included in Section F. Other Direct Costs when applicable.
1. Tuition/Fees/Health Insurance:
List the total funds requested for Participant/Trainee Tuition/Fees/Health Insurance.
2. Stipends:
List the total funds requested for Participant/Trainee stipends.
3. Travel:
List the total funds requested for Participant/Trainee travel.
4. Subsistence:
List the total funds requested for Participant/Trainee subsistence.
5. Other:
Describe any other Participant/Trainee support costs and list the total funds requested for all
other Participant/Trainee costs described.
Number of Participants/Trainees:
List the total number of proposed Participants/Trainees. Value cannot be greater than 999.
Total Participant/Trainee Support Costs:
This field is required if any data has been entered in “Section E. Participant/Trainee Support
Costs.” This total will be automatically calculated based on the sum of the Funds Requested
column in "Section E. Participant/Trainee Support Costs."
F. Other Direct Costs
1. Materials and Supplies:
List the total funds requested for materials and supplies. In Section L. Budget Justification,
indicate general categories such as glassware, chemicals, animal costs, etc., including an amount
for each category. Categories with amounts less than $1,000 are not required to be itemized.
Additional Instructions for Career Development:
In the "Material and Supplies" field, enter the total research development support
being requested for the initial budget period of the career development award.
Usually, a specific total amount is allowed for research development and other
costs (tuition, fees, research supplies, equipment, computer time, travel, etc.) that
do not require individual cost category identification. Unless instructed differently
in the applicable FOA, applicants should enter only the total requested research
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development support (RDS) amount in this box. All remaining budget fields in this
section should be left blank.
Please note that while this method of entering only the total requested research
development support costs in "Section F. Other Direct Cost" will be simplest for
most applicants, some applicants, including some system-to-system applicants,
may instead choose to enter those costs in the applicable detailed budget
categories. When choosing this option, it is still the applicant’s responsibility to
make certain the total research development support costs do not exceed the
allowable total.
Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If costs for
human fetal tissue obtained from elective abortions (HFT) as defined in the NIHGrants Policy
Statement are included in the proposed budget, they must not be included here but listed as a
specific line item under Section F.8-10 Other.
2. Publication Costs:
List the total funds requested for publication costs. The proposal budget may request funds for
the costs of documenting, preparing, publishing, or otherwise making available to others, the
findings and products of the work conducted under the award. Include supporting information
in Section L. Budget Justification.
3. Consultant Services:
List the total funds requested for all consultant services. Identify the following items in Section L.
Budget Justification, as applicable:
l each consultant, the services he/she will perform, total number of days, travel costs, and
the total estimated costs;
l the names and organizational affiliations of all consultants, other than those involved in
consortium/contractual arrangements;
l consulting physicians in connection with patient care; and
l persons who are confirmed to serve on external monitoring boards or advisory
committees to the project. Describe the services to be performed.
4. Automatic Data Processing (ADP)/Computer Services:
List the total funds requested for ADP/computer services. The cost of computer services,
including computer-based retrieval of scientific, technical, and education information may be
requested. In Section L. Budget Justification, include the established computer service rates at
the proposing organization, if applicable.
5. Subawards/Consortium/Contractual Costs:
List the total funds requested for:
1. all subaward/consortium organization(s) proposed for the project and
2. any other contractual costs proposed for the project.
This line item should include both direct and indirect costs for all subaward/consortium
organizations.
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Contractual costs for support services, such as laboratory testing of biological materials, clinical
services, or data processing, are occasionally sufficiently high to warrant a categorical breakdown
of costs. When this is the case, provide detailed information as part of Section L. Budget
Justification.
NIH policy provides for exclusion of consortium/contractual F&A costs when determining if an
applicant is in compliance with a direct cost limitation. However, you must include the full cost of
consortium/subawards in this field. See the NIH Grants Policy Statement, Section 2.3.7.1:
Applications that Include Consortium/Contractual F&A Costs for policy related to the exclusion
of consortium/subaward amounts in determining whether an applicant is in compliance with a
direct cost limitation.
6. Equipment or Facility Rental/User Fees:
List the total funds requested for equipment or facility rental/user fees. In Section L. Budget
Justification, identify and justify each rental user fee.
7. Alterations and Renovations:
List the total funds requested for alterations and renovations (A&R). In Section L. Budget
Justification, itemize by category and justify the costs of alterations and renovations, including
repairs, painting, and removal or installation of partitions, shielding, or air conditioning. Where
applicable, provide the square footage and costs.
Under certain circumstances the public policy requirements that apply to construction activities
may also apply to A&R activities. Refer to the NIH Grants Policy Statement, Section 10.10:
Construction Grants – Public Policy Requirements and Objectives for more information.
Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): Minor
A&R costs (≤$500,000) are allowable on applications from foreign organizations and domestic
institutions with foreign components. When requesting minor A&R costs under this policy,
please provide detailed information on the planned A&R in the budget justification.
8-10 Other:
Add descriptions for any “other” direct costs not requested above. Use Section L. Budget
Justification to further itemize and justify.
List funds requested for each of the items in lines "8-10 Other.” Use lines 8-10 for costs such as
patient care and tuition remission. If requesting patient care costs, request inpatient and
outpatient costs separately.
Lines "8-10 Other" may also be used to request direct costs related to the use of single
Institutional Review Board (sIRB)for multi-site human subjects research.
For more information on charging direct and indirect costs for single IRBactivities, see the
Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRBReview under the
NIHPolicy on the Use of a Single IRBfor Multi-Site Research.
Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use
of human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy
Statement) is included in the proposed application, regardless of whether costs will be incurred,
it must be noted as a single line item here. The line item must be titled “Human Fetal Tissue
Costs” (without quotation marks, but following exact phrase and spacing). The line item must
only be used for HFT costs and cannot include or be combined with any “Other” costs. If no cost
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will be incurred (e.g. if HFT will be donated), enter “0” in the “Funds Requested” column. Details
regarding HFT must be specified in the Budget Justification attachment (L), pursuant to the
instructions.
Applications proposing HFT that do not address these requirements will be administratively
withdrawn. For further information on HFTpolicy refer to the NIHGrants 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.
Total Other Direct Costs:
This total will be automatically calculated based on the sum of the Funds Requested column in
"Section F. Other Direct Cost."
G. Direct Costs
This total will be automatically calculated based on the sum of the Total funds requested for all
direct costs (sections A-F).
H. Indirect Costs
Indirect costs (Facilities & Administrative [F&A] costs) are defined as costs that are incurred by a
grantee for common or joint objectives and that, therefore, cannot be identified specifically with
a particular project or program. See the NIH Glossary's definition of Indirect Costs.
For more information:
You are encouraged to visit the following Defense Finance and Accounting Services (DFAS)
Websites or call DFAS staff at 301-496-2444 for guidance: Main DFAS website, DFAS Frequently
Asked Questions. The following website has a listing of unallowable and unallocable costs and
the related Federal Acquisition Regulation (FAR) citation for each: NIH Office of Management's
Unallowable/Unallocable Costs.
Refer to the NIH Grants Policy Statement, Section 7.4: Reimbursement of Facilities and
Administrative Costs for more information.
Special Instructions for Foreign Organizations (Non-domestic [non-U.S.] Entities): Foreign
institutions and international organizations may request funds for limited F&A costs (8% of
modified total direct costs less equipment) to support the costs of compliance with HHS and NIH
requirements including, but not limited to, those related to the protection of human subjects,
animal welfare, invention reporting, financial conflict of interest, and research misconduct. Foreign
organizations may not include any charge-back of customs and import fees, such as consular fees,
customs surtax, value-added taxes (VAT), and other related charges.
Indirect Cost Type:
Enter the type of indirect cost (e.g., Salary & Wages, Modified Total Direct Costs, etc.) and
whether the cost is off-site. If more than one rate or base is involved for a given type of indirect
cost, then list them as separate entries. If you do not have a current indirect (F&A) rate(s)
approved by a federal agency, indicate “None--will negotiate” and include information for a
proposed rate. Use Section L. Budget Justification if additional space is needed.
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Additional Instructions for Career Development:
Indicate the Indirect Cost type as Modified Total Direct Costs.
Indirect Cost Rate (%):
Enter the most recent indirect cost rate(s) established with the cognizant federal office, or in the
case of for-profit organizations, the rate(s) established with the appropriate agency. If you have a
cognizant/oversight agency and are selected for an award, you must submit your indirect rate
proposal to the NIH awarding IC or to the PHS awarding office for approval. If you do not have a
cognizant/oversight agency, contact the awarding agency. This field should be entered using a
rate such as “55.5.”
Additional Instructions for Career Development:
Enter the indirect cost rate as 8%. For all career development award applications,
indirect costs are reimbursed at 8% of modified total direct costs (exclusive of
tuition and fees and expenditures for equipment) rather than on the basis of a
negotiated rate agreement.
Indirect Cost Base ($):
Enter the amount of the base for each indirect cost type.
Funds Requested ($):
Enter the funds requested for each indirect cost type.
Total Indirect Costs:
This total will be automatically calculated from the “Funds Requested” column in "Section H.
Indirect Cost."
Cognizant Federal Agency:
Enter the name of the cognizant Federal Agency and the name and phone number of the
individual responsible for negotiating your rate (your point of contact). If no cognizant agency is
known, enter “None.”
Additional Instructions for Career Development:
You may either follow the general instructions above to complete the "Cognizant
Federal Agency" field or you may enter “Not Applicable.” Either response is
acceptable since indirect costs will be reimbursed as 8% of modified total direct
costs rather than on the basis of a negotiated rate agreement.
I. Total Direct and Indirect Costs
This total will be automatically populated from the sum of Total Direct Costs (from Section G.
Direct Cost) and the Total Indirect Costs (from Section H. Indirect Costs).
J. Fee
Do not include a fee in your budget, unless the FOA specifically allows inclusion of a “fee.” If a fee
is allowable, enter the requested fee.
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K. Total Costs and Fee
This total will be automatically calculated from the sum of Total Direct Costs and Fee (from
sections “I. Total Direct and Indirect Costs” and “J. Fee”).
L. Budget Justification
The “Budget Justification” attachment is required. Attach only one file.
Use the Budget Justification to provide the additional information requested in each budget
category identified above and any other information the applicant wishes to submit to support
the budget request. If you have a quote(s), you may include it here. The following budget
categories must be justified, where applicable: equipment, travel, participant/trainee support,
and other direct cost categories.
In addition to the justifications described in the above sections, also include a justification for any
significant increases or decreases from the initial budget period. Justify budgets with more than
a standard escalation from the initial to the future year(s) of support.
Also use the Budget Justification to explain any exclusions applied to the F&A base calculation.
If your application includes a subaward/consortium budget, a separate Budget Justification must
be submitted. See K.310 - R&R Subaward Budget Attachment(s) Form.
Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use
of human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy
Statement) is included in the proposed application include a detailed justification including the
quantity, type(s), and source(s) of the HFT, including the stage of fetal development. This
information must be included if costs for the HFT are assigned to the grant or if the HFT is
acquired under the grant at no costs. The HFT justification must be clearly labeled in the budget
justification attachment.
Additional Instructions for Career Development:
Use the Budget Justification to provide a detailed description and justification for
specific items within the Research Development Support costs (e.g., all equipment,
supplies, and other personnel that will be used to help achieve the career
development and research objectives of this award).
Research & Related Budget - Cumulative Budget
All values on this form are automatically calculated, and the fields are pre-populated. They
present the summations of the amounts you entered previously, under Sections A through K, for
each of the individual budget periods. Therefore, no data entry is allowed or required to
complete this “Cumulative Budget” section.
If any of the amounts displayed on this form appear to be incorrect, you may correct it by
adjusting one or more of the values that contribute to that total. To make any such corrections,
you will need to revisit the appropriate budget period form(s).
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K.310 - R&R Subaward Budget
Attachment(s) Form
The R&R Subaward Budget Attachment(s) Form is used
for applications with a subaward or consortium.
This form is required only when the prime grantee is
submitting an R&R Budget Form and has
subaward/consortium budgets.
Applicants using the Modular Budget Form should see
K.320 - Modular Budget Form for instructions
concerning information on consortium budgets.
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Who should use the R&R Subaward Budget Attachment(s) Form?
The R&R Subaward Budget Attachment(s) Form is required if you have a subaward/consortium and
are using the K.300 - R&R Budget Form.
Do not use this form if you are using the PHS Modular Budget Form or if you do not have a
subaward/consortium.
Each consortium grantee organization that performs a substantive portion of the project must
complete an R&R Subaward Budget Attachment, including the Budget Justification section.
Consortium/Contractual F&A Costs:
NIH policy provides for the exclusion of consortium/contractual F&A costs when determining if an
applicant is in compliance with a direct cost limitation. However, you must include the full cost of
subaward/consortium in the Subawards/Consortium Costs field (K.300 - R&R Budget Form, Section F.
Other Direct Costs, Question 5). If a subaward/consortium is not performing a substantive portion of
the project, they do not need to complete an R&R Subaward Budget Form; however, their costs must
be included in the prime grantee’s R&R Budget Form. All F&A costs count toward the direct cost limit.
Refer to the NIH Grants Policy Statement, Section 2.3.7.1: Applications That Include
Consortium/Contractual F&A Costs for policy related to the exclusion of consortium/subaward
amounts in determining whether an applicant is in compliance with a direct cost limitation.
Applicants should document how their budget falls below the direct cost limit in their Budget
Justification on the R&R Subaward Budget Form.
Note on Project Roles for Consortium Lead Investigators:
It is appropriate and expected that someone may serve as the consortium lead investigator
responsible for ensuring proper conduct of the project or program at each subaward or consortium
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site.
Unless you are submitting your application under the multiple PD/PI policy, consortium lead
investigators are NOT considered PD/PIs for the “Project Role” field. This individual should be assigned
some other project role on the K.300 - R&R Budget Form and in the K.240 – R&R Senior/Key Person
Profile (Expanded) Form. However, the project role of “PD/PI” should be used for a consortium lead
investigator if they also serve as PD/PI for the entire application under the multiple PD/PI policy.
Using the R&R Subaward Budget Attachment(s) Form:
The location of the R&R Subaward Budget Attachment(s) Form may vary with the type of submission
(e.g., under an “Optional Forms” tab).
The steps needed to include a subaward budget in your application vary by submission method. If
submitting using the Grants.gov Workspace, the prime applicant can extract a copy of the R&R
Budget Form from the R&R Subaward Budget Attachment(s) Form and send the extracted file to the
consortium for completion. After the consortium completes the R&R Budget Form, following the
instructions here and in K.300 – R&R Budget Form, the prime grantee must then upload the R&R
Budget Form to the R&R Subaward Budget Attachment(s) Form.
For all submission methods, the R&R Budget Form with a "Budget Type" of Subaward/Consortium is
used to collect subaward budget data. However, ASSIST and other system-to-system solutions may
present a different interface than the R&R Subaward Budget Attachment Form shown here.
This form accommodates a set number of separate subaward budgets. If you need to add more
subaward budgets than the form allows, include the remaining budgets as part of Budget
Justification in K.300 – R&R Budget Form.
Regardless of how many subaward budgets you include, the sum of all subaward budgets (those
attached within the R&R Subaward Budget Attachment(s) Form and those provided as part of the
project budget’s Budget Justification), must be included in K.300 - R&R Budget Form, Section F. Other
Direct Costs, Question 5. Subawards/Consortium/Contractual Costs of the project budget.
Format:
All attachments, including all Subaward Budget Forms and Budget Justifications, must be PDF files.
The R&R Budget Forms are already PDFs when extracted. Do not alter the format.
Content:
On this R&R Subaward Budget Attachment(s) Form, you will attach the R&R Subaward Budget files
for your application. Each consortium should complete the Subaward Budget(s) in accordance with
the K.300 - R&R Budget Form instructions.
Submitting Subaward Budgets that are not Active for all Periods of the Prime Grant:
The R&R Budget Forms do not allow for “empty” budget periods.
Subaward/consortiums organizations should complete all budget periods in the R&R Subaward
Budget Form for their subaward budgets, aligning the budget period numbers, start dates, and end
dates with the budget periods of the prime grant.
Example: The prime fills out an R&R Budget Form with the following periods:
l period 1 - Jan 1, 2017 – Dec 31, 2017
l period 2 - Jan 1, 2018 – Dec 31, 2018
l period 3 - Jan 1, 2019 – Dec 31, 2019
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l period 4 - Jan 1, 2020 – Dec 31, 2020
l period 5 - Jan 1, 2021 – Dec 31, 2021
The budget period numbers and dates should be the same in all the R&R Subaward Budget Forms
included in the R&R Subaward Budget Attachment(s) Form.
The R&R Subaward Budget Forms include several required fields which must be completed (even for
inactive periods) in order to successfully submit the application. Provide the following information for
inactive budget periods in subaward/consortium budgets:
l Organization DUNS
l Budget Type = Subaward/Consortium
l Budget Period Start/End Dates (align with budget periods and dates of the prime budget)
l In Question "A: Senior/Key Person," provide a single entry including the following:
o
PD/PI or subaward lead First and Last names
o
Project Role (may default to PD/PI; can be adjusted as needed)
o
Calendar Months = .01 (smallest amount effort allowed in the field)
o
Requested Salary = $0
o
Fringe Benefits = $0
l Explanation of the inactive budget periods in the Budget Justification of the
subaward/consortium's R&R Subaward Budget Form
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K.410 - PHS 398 Career Development
Award Supplemental Form
The PHS 398 Career Development Award Supplemental
Form is used only for career development applications
and multi-project applications with an "Indiv. Career
Dev" Component.
This form includes fields to upload several attachments
including the Specific Aims, Research Strategy, and
Candidate Background and Goals.
See NIH's Reference Letters page for information
including instructions for referees and how to submit
letters.
The attachments in this form, together with the rest of
your application, should include sufficient information
needed for evaluation of the project and the candidate,
independent of any other documents (e.g., previous
application). Be specific and informative, and avoid
redundancies.
View larger image
Quick Links
Introduction
1. Introduction to Application (for Resubmission and Revision applications)
Candidate Section
2. Candidate Information and Goals for Career Development
Research Plan Section
3. Specific Aims
4. Research Strategy
5. Progress Report Publication List (for Renewal applications)
6. Training in the Responsible Conduct of Research
Other Candidate Information Section
7. Candidate's Plan to Provide Mentoring
Mentor, Co-Mentor, Consultant, Collaborators Section
8. Plans and Statements of Mentor and Co-Mentor(s)
9. Letters of Support from Collaborators, Contributors, and Consultants
Environment and Institutional Commitment to Candidate Section
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10. Description of Institutional Environment
11. Institutional Commitment to Candidate's Research Career Development
12. Description of Candidate’s Contribution to Program Goals
Other Research Plan Sections
13. Vertebrate Animals
14. Select Agent Research
15. Consortium/Contractual Arrangements
16. Resource Sharing
17. Authentication of Key Biological and/or Chemical Resources
Appendix
18. Appendix
Citizenship
19. U.S. Citizen or Non-Citizen National?
Who should use the PHS 398 Career Development Award Supplemental Form:
Use the PHS 398 Career Development Award Supplemental Form only if you are submitting a career
development application or a multi-project application that has an "Indiv. Career Dev" Component.
Some sections of the PHS 398 Career Development Award Supplemental Form are required for all
career development award applications, while others are to be used only when required by the FOA.
Read all the instructions in the FOA before completing this section to ensure your application meets
all IC-specific criteria.
Applicants must follow all policies and requirements related to formatting, page limits, and
proprietary information. See the following pages for more information:
l Format Attachments
l Page Limits
l NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information
l NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act
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Introduction
1. Introduction to Application (for Resubmission and Revision applications)
Who must complete the “Introduction to Application” attachment:
An "Introduction to Application" attachment is required only if the type of application is
resubmission or revision. An introduction is not allowed for new or renewal applications.
Descriptions of different types of applications are listed here: NIH Types of Applications.
Format:
Follow the page limits for the Introduction in the NIH Table of Page Limits unless otherwise
specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Resubmission applications: See specific instructions on the content of the Introduction on the
NIH's Resubmission Applicationspage.
Competing Revisions: See specific instructions on the content of the Introduction on the NIH's
Competing Revisionspage.
Candidate Section
2. Candidate Information and Goals for Career Development
Who must complete the "Candidate Information and Goals for Career Development"
attachment:
The “Candidate Information and Goals for Career Development” attachment is required.
Format:
Follow the page limits for Candidate Information and Goals for Career Development in the
NIHTable of Page Limits, unless otherwise specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Organize your attachment into three sections, following the headings and specified order below,
and discuss each of the points listed below. Start each section with the appropriate section
heading – Candidate’s Background, Career Goals and Objectives, and Candidate’s Plan for Career
Development/Training Activities During Award Period. Also include any additional information
requested in the FOA.
Candidate’s Background:
l Describe your past scientific history, indicating how the award fits into past and future
research career development.
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l If there are consistent themes or issues that have guided previous work, these should be
made clear. Alternatively, if your work has changed direction, indicate the reasons for the
change.
Career Goals and Objectives:
l Describe your short-term and long-term career development goals.
l Justify the need for the award by describing how the career development award will
enable you to develop and/or expand your research career.
l If applicable (e.g., K24), describe how this award will help you to serve as a mentor to
early career investigators.
Candidate’s Plan for Career Development/Training Activities During Award Period:
l Describe the new or enhanced research skills and knowledge you will acquire as a result
of the proposed award, including, as applicable, expertise in rigorous research design,
experimental methods, quantitative approaches and data analysis and interpretation.
l For non-mentored career development awards, describe any planned release from
teaching, administrative, and/or clinical duties that will help you focus on your research
activities, and if applicable, your mentoring activities.
l For mentored career development awards, describe any structured activities that are
part of the developmental plan, such as coursework or workshops that will help you
learn new techniques or develop needed professional skills.
l Briefly discuss each of the activities, other than research, in which you expect to
participate.
l For each activity, other than research, explain how it relates to the proposed research
and to the career development plan. Indicate the percentage of time to be dedicated to
each activity by year, expressed in person months. For more information about
calculating person months, see NIH's Frequently Asked Questions on Person Months.
l You are encouraged to include a timeline, including plans to apply for subsequent grant
support.
Research Plan Section
A Research Plan is required for all types of individual career development awards.
The information in these introductory paragraphs to the Research Plan Section applies to all four
Research Plan attachments: Specific Aims, Research Strategy, Progress Report Publication List,
and Training in the Responsible Conduct of Research.
The Research Plan is a major part of the overall career development goal. It is important to relate
the proposed research to the candidate's scientific career goals. Describe how the research,
coupled with other developmental activities, will provide the experience, knowledge, and skills
necessary to achieve the objectives of the career development plan. Also describe how the
research and other developmental activities will enable the candidate to launch and conduct an
independent research career or enhance an established research career.
For most types of research, the Research Plan Section should include:
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l a specific hypothesis,
l a list of the specific aims and objectives that will be used to examine the hypothesis,
l a description of the methods/approaches/techniques to be used in each aim,
l a discussion of possible problems and how they will be managed, and
l alternative approaches that might be tried if the initial approaches do not work.
A Career Development Award (CDA) Research Plan is expected to be tailored to the experience
level of the candidate and to allow him/her to develop the necessary skills needed for further
career advancement. Reviewers will evaluate the plan accordingly. The plan should be achievable
within the requested time period. Pilot or preliminary studies and routine data gathering are
generally not appropriate as the sole part(s) of a CDA Research Plan.
Although candidates for mentored career development awards are expected to write the
Research Plan, the mentor should review a draft of the plan and discuss it in detail with the
candidate. Review by other knowledgeable colleagues is also helpful. Although it is understood
that CDA applications do not require the extensive detail usually incorporated into regular
research grant applications, a fundamentally sound Research Plan that includes a reasonably
detailed Research Strategy section should be provided.
3. Specific Aims
Who must complete the “Specific Aims” attachment:
The "Specific Aims" attachment is required unless otherwise specified in the FOA.
Format:
Follow the page limits for the Specific Aims in the NIHTable of Page Limits, unless otherwise
specified in the FOA. A “Specific Aims” attachment that exceeds the page limit will be flagged as
an error by the Agency upon submission.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
State concisely the goals of the proposed research and summarize the expected outcome(s),
including the impact that the results of the proposed research will have on the research field(s)
involved.
List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis,
create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice,
address a critical barrier to progress in the field, or develop new technology).
4. Research Strategy
Who must complete the "Research Strategy" attachment:
The “Research Strategy” attachment is required.
Format:
Follow the page limits for the Research Strategy in the NIHTable of Page Limits, unless otherwise
specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
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Content:
Organize the Research Strategy in the specified order and use the instructions provided below.
Start each section with the appropriate heading – Significance, Innovation, Approach.
Cite published experimental details in the Research Strategy section and provide the full
reference in K.220 - R&R Other Project Information Form, Bibliography and References Cited.
In general, less detail will be expected in descriptions of research planned for the future years of
the proposed CDA compared to the initial years’ descriptions. However, sufficient detail should
be provided to enable peer reviewers to determine that the plans for those years, including the
approach to be used, are worthwhile and are likely to enable the candidate to achieve the
objectives of the Research Plan.
Note for mentored CDA applications: Explain the relationship between the candidate’s
research on the CDA and the mentor’s ongoing research program.
Note for non-mentored CDA applications: In general, non-mentored CDA applicants are
expected to have independent, peer-reviewed research support. Applications should include a
brief description of currently funded research, along with a more extensive description of any
new research to be supported by the CDA.
Note for Applications Proposing the Use of Human Fetal Tissue:
If the use of human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH
Grants Policy Statement) is included in the proposed application you must include specific
information in the Approach section of the Research Strategy attachment. See specific
instructions below in Section 3. Approach. This information must be provided regardless of
whether Human Subjects research is proposed or not. These specific instructions do not apply to
institutional career development applications (e.g. K12, KL2).
Note for Applications Proposing the Involvement of Human Subjects and/or Clinical Trials:
l Use the Research Strategy section to discuss the overall strategy, methodology, and analyses
of your proposed research, but do not duplicate information collected in the PHS Human
Subjects and Clinical Trials Information form.
l The PHS Human Subjects and Clinical Trials Information form will capture detailed study
information, including eligibility criteria; inclusion of women, minorities, and children;
protection and monitoring plans; and statistical design and power.
l You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials
Information form as appropriate in your discussion of the Research Strategy (e.g., see
Question 2.4 Inclusion of Women and Minorities).
Note for Applicants with Multiple Specific Aims: You may address the Significance, Innovation,
and Approach either for each Specific Aim individually or for all of the Specific Aims collectively.
1. Significance
l Explain the importance of the problem or critical barrier to progress that the proposed
project addresses.
l 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.
l Explain how the proposed project will improve scientific knowledge, technical capability,
and/or clinical practice in one or more broad fields.
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l Describe how the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field will be changed if the proposed aims are achieved.
2. Innovation
l Explain how the application challenges current research or clinical practice paradigms.
l Describe any novel theoretical concepts, approaches or methodologies, instrumentation
or interventions to be developed or used, and any advantage over existing
methodologies, instrumentation, or interventions.
3. Approach
l 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 section,
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.
l 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.
l Discuss potential problems, alternative strategies, and benchmarks for success
anticipated to achieve the aims.
l 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.
l 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.
l Point out any procedures, situations, or materials that may be hazardous to personnel
and precautions to be exercised. A full discussion on the use of select agents should
appear in the Select Agent Research section below.
l 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.
l 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.
l
Special Instructions for Applications Proposing the Use of Human
Fetal Tissue:
If the use of human fetal tissue obtained from elective abortions (HFT) (as
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defined in the NIH Grants Policy Statement) is included in the proposed
application:
l Use the specific heading: “Human Fetal Tissue Research
Approach”.
l Describe the proposed characteristics, procurement, and
procedures for the research use of HFT. The description should be
sufficiently detailed to permit meaningful evaluation by NIH.
l Justify the use of HFT in the proposed research by indicating the
following:
l Why the research goals cannot be accomplished by using
an alternative to HFT.
l What methods were used (e.g. literature review,
preliminary data) to determine that alternatives could not
be used.
l Results from a literature review used to provide
justifications.
l Plans for the treatment of HFT and the disposal of HFT
when research is complete.
l Description of planned written, voluntary, informed
consent process for cell/tissue donation, or description
and documentation of process if cells/tissue were already
obtained.
l Note: These specific instructions do not apply to
institutional career development applications (e.g.
K12).
l Applications proposing HFT that do not address
these requirements will be administratively
withdrawn. For further information on HFTpolicy
refer to the NIHGrants 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.
As applicable, also include the following information as part of the Research Strategy,
keeping within the three sections (Significance, Innovation, and Approach) listed above.
Preliminary Studies (for New Applications):
For new applications, include information on preliminary studies. Discuss the PD/PI’s
preliminary studies, data, and or experience pertinent to this application.
Progress Report (for Renewal and Revision Applications):
Most career development applicants will not complete this attachment. However, if you are
required to do so, note that the Progress Report falls within the Research Strategy and is
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therefore included in the page limits for the Research Strategy.
For renewal/revision applications, provide a Progress Report. Provide the beginning and
ending dates for the period covered since the last competitive review. In the Progress
Report, you should:
l Summarize the specific aims of the previous project period and the importance of the
findings, and emphasize the progress made toward their achievement.
l Explain any significant changes to the specific aims and any new directions, including
changes resulting from significant budget reductions.
l Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women,
minorities, children, etc.) for any studies meeting the NIH definition for clinical research.
Use the Progress Report section to discuss, but not duplicate information collected
elsewhere in the application.
Do not include a list of publications, patents, or other printed materials in the Progress
Report. That information should be included in the "Progress Report Publication List"
attachment.
5. Progress Report Publication List (for Renewal applications)
Who must complete the “Progress Report Publication List” attachment:
A “Progress Report Publication List” attachment is required only if the type of application is
renewal. Most career development applicants will not complete this attachment.
Descriptions of different types of applications are listed here: NIH's Types of Applications.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
List the titles and complete references to all appropriate publications, manuscripts accepted for
publication, patents, and other printed materials that have resulted from the project since it was
last reviewed competitively.
You are allowed to cite interim research products. Note: interim research products have specific
citation requirements. See related Frequently Asked Questions on citing interim research
products and claiming them as products of your NIH award.
Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed
Central (PMC) reference number (e.g., PMCID234567) for the following:
l Articles that fall under the Public Access Policy,
l Articles that were authored or co-authored by the applicant and arose from NIH
support,
l Articles that were authored or co-authored by the applicant and arose from AHRQ
funding provided after February 19, 2016 (see the Guide Notice on Policy for Public
Access to AHRQ-Funded Scientific Publications).
If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of
their authors, indicate “PMC Journal – In Process.” NIHmaintains a list of such journals.
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Citations that are not covered by the Public Access Policy, but are publicly available in a free,
online format may include URLs or PubMed ID (PMID) numbers along with the full reference.
6. Training in the Responsible Conduct of Research
Who must complete the "Training in the Responsible Conduct of Research" attachment:
The “Training in the Responsible Conduct of Research” attachment is required.
Format:
Follow the page limits for the Training in the Responsible Conduct of Research in the NIHTable
of Page Limits unless otherwise specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Mentored CDA applications should describe a plan to acquire instruction in the responsible
conduct of research (RCR).
Non-mentored (independent) CDAapplications should describe a plan to obtain or provide
instruction in RCR, depending on your level of experience with RCR.
Attach a description of plans for obtaining or providing instruction in RCR. This section should
document prior instruction or participation in RCR training during the applicant’s current career
stage (including the date instruction was last completed). This section should also propose plans
to either receive instruction or provide instruction (e.g., to participate as a course lecturer) to
meet the frequency requirement of RCR training (see the “For more information section” below).
The plan must address the five required instructional components outlined in the NIH Policy on
Instruction in the Responsible Conduct of Research (RCR), as more fully described in the NIH
Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of Research.
1. Format: Describe the required format of instruction, i.e., face-to-face lectures,
coursework, and/or real-time discussion groups (a plan with only on-line instruction is
not acceptable).
2. Subject Matter: Describe the breadth of subject matter (e.g., conflict of interest,
authorship, data management, human subjects and animal use, laboratory safety,
research misconduct, research ethics).
3. Faculty Participation: Describe the role of the mentor(s) and other faculty involvement
in the instruction.
4. Duration of Instruction: Describe the number of contact hours of instruction, taking
into consideration the duration of the program.
5. Frequency of Instruction: Instruction must occur during each career stage and at least
once every four years. Document any prior instruction during the applicant’s current
career stage, including the inclusive dates instruction was last completed.
The plan may include career stage-appropriate individualized instruction or independent
scholarly activities. Instruction and activities should enhance the applicant’s understanding of
ethical issues related to their specific research activities and the societal impact of that research.
The role of the mentor in RCR instruction must be described.
Renewal Applications: Describe the RCR instruction activities undertaken during the previous
project period as well as future plans for RCR instruction.
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For more information:
See the NIH Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of
Research.
Other Candidate Information Section
7. Candidate’s Plan to Provide Mentoring
Who must complete the “Candidate’s Plan to Provide Mentoring” attachment:
Include the “Candidate’s Plan to Provide Mentoring” attachment only when required by the FOA,
(e.g., K05 and K24).
Format:
Follow the page limits for the Candidate’s Plan to Provide Mentoring in the NIH Table of Page
Limits unless otherwise specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
The plan should provide information about both the candidate’s commitment to serve as a
mentor to other investigators and the candidate’s previous mentoring activities. State the
candidate’s proposed percent effort commitment to the mentoring plan, expressed in person
months. For more information about calculating person months, see NIH's Frequently Asked
Questions on Person Months.
Describe proposed mentoring activities: Describe the setting for mentoring and provide
information about the available pool of mentees with appropriate backgrounds and similar
interests in science as the candidate. Include information sufficient for reviewers to evaluate the
quality of the proposed mentoring experience, including the professional levels of mentees and
the frequency and kinds of mentoring interactions between the candidate and mentees.
Describe the productivity of the mentoring relationship for the scientific development of the new
scientists as judged by their publications and current research activities.
Describe past mentoring activities: Include sufficient information on the candidate’s past
mentees so that reviewers can evaluate the quality of prior mentoring experiences. Include
information such as the professional levels of mentees, and the frequency and kinds of
mentoring interactions between the candidate and mentees.
Senior level (K05) candidates: Describe any financial and material support from your own
funded research and research resources that will be available to your mentees.
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Mentor, Co-Mentor, Consultant, Collaborators Section
8. Plans and Statements of Mentor and Co-Mentor(s)
Who must complete the “Plans and Statements of Mentor and Co-Mentor(s)” attachment:
Any candidate applying for a mentored CDA (see Summary of Career Development Award
Mechanisms table) must include a "Plans and Statement of Mentor and Co-Mentor(s)"
attachment.
All mentored career development applications should identify any and all co-mentors involved
with the proposed research and career development program. The mentor and each co-mentor
must provide a statement as described below.
Format:
Follow the page limits for the Plans and Statements of Mentor and Co-mentor(s) in the NIHTable
of Page Limits unless otherwise specified in the FOA.
The plans and statements must be appended together and uploaded as a single PDF file. See
NIH's Format Attachments page.
Content:
The mentor and co-mentor(s) (if applicable) must each document their role and willingness to
participate in the project, and explain how they will contribute to the development of the
candidate's research career. Each statement should include all of the following:
1. The plan for the candidate's training and research career development. Include
information not only about research, but also about other developmental activities, such
as seminars, scientific meetings, training in RCR, and presentations. Discuss expectations
for publications over the entire period of the proposed project. Define what aspects of
the proposed research project the candidate will be allowed to continue to pursue as
part of his/her independent research program.
2. The source of anticipated support for the candidate’s research project for each year of
the award period.
3. The nature and extent of supervision and mentoring of the candidate, and commitment
to the candidate's development that will occur during the award period.
4. The candidate's anticipated teaching load for the award period (number and types of
courses or seminars), clinical responsibilities, committee and administrative assignments,
and the portion of time available for research.
5. A plan for transitioning the candidate from the mentored stage of his/her career to the
independent investigator stage by the end of the project period of the award. Describe
the mentor's (or co-mentor’s) previous experience as a mentor, including type of
mentoring (e.g., graduate students, career development awardees, postdoctoral
fellows), number of persons mentored, and career outcomes.
Note for co-mentor statements: Co-mentors must also address the nature of their role in the
career development plan and how the responsibility for the candidate’s development is shared
with the mentor. Describe respective areas of expertise and how they will be combined to
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enhance the candidate’s development. Also describe the nature of any resources that will be
committed to this CDA.
Note: If the applicant is proposing to gain experience in a clinical trial as part of his or her
research career development, then the mentor or a member of the mentoring team should
include information in the statement to document leadership of the clinical trial (in addition to
the information above). Include the following:
l Source of funding;
l ClinicalTrials.gov Identifier (e.g., NCT87654321), if applicable;
l A description of how your expertise is appropriate to guide the applicant in any
proposed clinical trials research experience; and
l A statement/attestation that the mentor will be responsible for the clinical trial.
l The mentor must have primary responsibility for leading and overseeing the trial and
must describe how she/he will provide this oversight (be careful not to overstate the
candidate’s responsibilities).
l Include details on the specific roles/responsibilities of the applicant and mentor, keeping
in mind that the terms of a CDA award do not always permit the candidate to lead a
clinical trial.
Do not place these statements from the mentor(s) and co-mentor(s) in the Appendix.
9. Letters of Support from Collaborators, Contributors, and Consultants
Note that letters of support are not the same as letters of reference (also known as reference
letters), which are required for some K applications. For more information about letters of
reference, see the NIH's Reference Letters page.
From whom are letters of support required? From whom are letters not required?
Letters of support from collaborators, contributors, and consultants will be required for any such
person who will contribute to the scientific development or execution of CDA application’s
proposed project. Follow the requirements for letters of support as listed in the FOA.
Letters are not required for personnel (such as research assistants) not contributing in a
substantive, measurable way to the scientific development or execution of the project.
Format:
Follow the page limits for the Letters of Support from Collaborators, Contributors, and
Consultants in the NIH Table of Page Limits unless otherwise specified in the FOA.
Attach all appropriate letters of support. The letters must be appended together and uploaded
as a single PDF file. See NIH's Format Attachments page.
Content:
Letters from consultants should include rates/charges for consulting services.
Mentored CDA applications should identify collaborators, contributors, and consultants
involved with the proposed research and career development program, and not already included
in the “Plans and Statements of Mentor(s) and Co-Mentor(s)” section. Letters should briefly
describe their anticipated contributions and document their role and willingness to participate in
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the project. The letters should also briefly describe research materials, data, guidance, or advice
each person will provide.
Non-mentored CDA applications should include letters from collaborators, consultants, and
contributors. Letters should list proposed roles and document their willingness to participate in
the project. The letters should also briefly describe research materials, data, guidance, or advice
each person will provide.
Environment and Institutional Commitment to Candidate Section
10. Description of Institutional Environment
Who must complete the "Description of Institutional Environment" attachment:
The “Description of Institutional Environment” attachment is required.
Format:
Follow the page limits for the Description of Institutional Environment in the NIH Table of Page
Limits unless otherwise specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Mentored CDA applicants: Describe the institution’s research and career development
opportunities related to your area(s) of interest, including the names of key faculty members and
other investigators relevant to your proposed developmental plan and capable of productive
collaboration with the candidate. Indicate how the necessary facilities and other resources will be
made available for both career enhancement and the research proposed in this application –
refer to the resources description in K.220 - R&R Other Project Information Form, Facilities and
Other Resources in your “Description of Institutional Environment” attachment. Describe
opportunities for intellectual interactions with other investigators, including courses offered,
journal clubs, seminars, and presentations.
Non-mentored CDA applicants: Describe the institution’s research and career development
opportunities related to your area(s) of interest, including the names of other faculty members
who are willing to collaborate with you. Indicate how the necessary facilities and other resources
will be made available for both career enhancement and the research proposed in this
application – refer to the resources description in K.220 - R&R Other Project Information Form,
Facilities and Other Resources in your “Description of Institutional Environment” attachment.
Describe opportunities for intellectual interactions with other investigators, including journal
clubs, seminars, and presentations.
11. Institutional Commitment to Candidate’s Research Career Development
Who must complete the "Institutional Commitment to Candidate's Research Career
Development" attachment:
The “Institutional Commitment to Candidate’s Research Career Development” attachment is
required.
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Format:
Follow the page limits for the Institutional Commitment to Candidate’s Research Career
Development in the NIH Table of Page Limits unless otherwise specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
The sponsoring institution must provide a document on institutional letterhead that describes
its commitment to the candidate and the candidate’s career development, independent of the
receipt of the CDA. It is also essential to document the institution's commitment to the retention,
development, and advancement of the candidate during the period of the award.
The “Institutional Commitment to Candidate’s Research Career Development” attachment should
generally document the institution’s agreement to provide adequate time, support, equipment,
facilities, and resources to the candidate for research and career development activities. See the
list below for specific items to include in the document.
In the document describing its institutional commitment, the applicant organization must:
1. Agree to release the candidate from other duties and activities so that the candidate can
devote the required percentage of time for development of a research career, as
specified by the FOA. For most K awards, commitment of at least 75 percent or nine
person months of time is required.
a. NIH and other PHS agencies use the concept of "person months" as a metric for
determining percent of effort. For more information about calculating person
months, see NIH's Frequently Asked Questions on Person Months.
2. Describe actions that will be taken to ensure that the candidate can devote the required
time to research career development (e.g., reduction of the candidate's teaching load,
committee and administrative assignments, and clinical or other professional activities
for the current academic year). If the candidate’s clinical or teaching responsibilities will
be reduced, describe how this will be accommodated (e.g., hiring additional staff,
reassigning staff, etc.).
3. Describe the candidate's academic appointment, bearing in mind that the appointment
must be full-time, and that the appointment (including all rights and privileges
pertaining to full faculty status if in an academic setting) and the continuation of salary
should not be contingent upon the receipt of this award.
4. Describe the proportion of time currently available for the candidate's research and what
the candidate's institutional responsibilities will be if an award is made.
5. Describe how the institution will provide the candidate with appropriate office and
laboratory space, equipment, and other resources (including access to clinical and/or
other research populations) to carry out the proposed Research Plan.
6. Describe how the institution will be supportive of any proposed mentor(s), other staff,
and/or collaborations with other faculty consistent with the career development plan.
Signatures:
The institutional commitment must be dated and signed by the person who is authorized to
commit the institution to the agreements and assurances listed above. In most cases, this
will be the dean or the chairman of the department. The signature must appear over the
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signer's name and title at the end of the statement. If the candidate will be working outside
of the applicant institution (i.e., sponsoring institution), signatures from both the
applicant/sponsoring institution and host institutions are required.
The sponsoring institution, through the submission of the application and in the
institutional commitment section, certifies that all items outlined above will be provided and
that the institution will abide by the applicable assurances and PHS policies.
Note: For applicable assurances, see the NIH Grants Policy Statement, Section 4: Public
Policy Requirements, Objectives and Other Appropriation Mandates.
12. Description of Candidate’s Contribution to Program Goals
Who must complete the "Description of Candidate’s Contribution to Program Goals"
attachment:
Applicants to diversity-related FOAs (e.g., diversity-related K01 and diversity-related K22s):
The “Description of Candidate’s Contribution to Program Goals” attachment is required.
All other Career Development applicants: Skip the “Description of Candidate’s Contribution to
Program Goals” attachment, as it is not required.
Format:
Attach this information as a PDF file. See NIH's Format Attachements page.
Content:
The sponsoring institution must provide a document on institutional letterhead that explains
how the candidate’s participation will further the goals of the career development program to
promote diversity in health-related research.
For NIH’s Interest in Diversity, see the Notice of NIH's Interest in Diversity (NOT-OD-20-031).
Signatures:
The “Description of Candidate’s Contribution to Program Goals” attachment must be dated
and signed by an institutional official. In most cases, this will be the dean or the chairman of
the department. The signature must appear over the signer's name and title at the end of
the statement.
Other Research Plan Sections
13. Vertebrate Animals
Who must complete the “Vertebrate Animals” attachment:
Include the “Vertebrate Animals” attachment if you answered “Yes” to the question “Are
Vertebrate Animals Used?” on the K.220 - R&R Other Project Information Form.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Do not use the Vertebrate Animals attachment to circumvent the page limits of the Research
Strategy.
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Content:
If live vertebrate animals are involved in the project, address each of the following criteria:
1. Description of Procedures: Provide a concise description of the proposed procedures to
be used that involve live vertebrate animals in the work outlined in the “Research
Strategy” attachment. The description must include sufficient detail to allow evaluation
of the procedures. Identify the species, strains, ages, sex, and total numbers of animals
by species, to be used in the proposed work. If dogs or cats are proposed, provide the
source of the animals.
2. Justifications: Provide justification that the species are appropriate for the proposed
research. Explain why the research goals cannot be accomplished using an alternative
model (e.g. computational, human, invertebrate, in vitro).
3. Minimization of Pain and Distress: Describe the interventions including analgesia,
anesthesia, sedation, palliative care, and humane endpoints that will be used to minimize
discomfort, distress, pain, and injury.
Each of the criteria must be addressed. Failure to adequately address the criteria may negatively
affect the application’s impact score. In addition to the 3 criteria above, you should also:
l Identify all project performance (or collaborating) sites and describe the proposed
research activities with vertebrate animals that will be conducted at those sites.
l Explain when and how animals are expected to be used if plans for the use of animals
have not been finalized.
See the following pages for more information:
l NIH’s Office of Laboratory Animal Welfare website
l NIH's Vertebrate Animals Section Worksheet
l NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements (an applicable
Animal Welfare Assurance will be required if the grantee institution does not have one)
14. Select Agent Research
Who must complete the “Select Agent Research” attachment:
Include the “Select Agent Research” attachment if your proposed activities involve the use of
select agents at any time during the proposed project period, either at the applicant
organization or at any performance site.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
For more information:
Select agents are hazardous biological agents and toxins that have been identified by HHS or the
U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public
health and safety, to animal and plant health, or to animal and plant products. The Centers for
Disease Control and Prevention (CDC) and the Animal APHIS Select Agent Programs jointly
maintain a list of these agents. See the Federal Select Agent Program website.
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See also the NIH Grants Policy Statement, Section 4.1.24.1: Public Health Security and Bioterrorism
Preparedness and Response Act (Select Agents).
Content:
Excluded select agents: If the activities proposed in your application involve only the use of a
strain(s) of select agents which has been excluded from the list of select agents and toxins as per
42 CFR 73.3, the select agent requirements do not apply. Use this “Select Agent Research” section
to identify the strain(s) of the select agent that will be used and note that it has been excluded
from this list. The CDC maintains a list of exclusions which is available on the Select Agents and
Toxins Exclusions website.
Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list
of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from
the list, use this section to indicate the status of your request or your intent to apply for an
exclusion and provide a brief justification for the exclusion.
All applicants proposing to use select agents: Address the following three points for each site
at which select agent research will take place. Although no specific page limitation applies to this
section, be succinct.
1. Identify the select agent(s) to be used in the proposed research.
2. Provide the registration status of all entities* where select agent(s) will be used.
l If the performance site(s) is a foreign institution, provide the name(s) of the country
or countries where select agent research will be performed.
l *An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or
local), academic institution, corporation, company, partnership, society, association,
firm, sole proprietorship, or other legal entity.”
3. Provide a description of all facilities where the select agent(s) will be used.
l Describe the procedures that will be used to monitor possession, use and transfer
of select agent(s).
l Describe plans for appropriate biosafety, biocontainment, and security of the select
agent(s).
l Describe the biocontainment resources available at all performance sites.
15. Consortium/Contractual Arrangements
Who must complete the “Consortium/Contractual Arrangements” attachment:
Include the “Consortium/Contractual Arrangements” attachment if you have
consortium/contracts in your budget.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Explain the programmatic, fiscal, and administrative arrangements to be made between the
applicant organization and the consortium organization(s). If consortium/contractual activities
represent a significant portion of the overall project, explain why the applicant organization,
rather than the ultimate performer of the activities, should be the grantee.
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Note: The signature of the authorized organization representative in K.200 – SF 424 (R&R),
Authorized Representative signifies that the applicant and all proposed consortium participants
understand and agree to the following statement:
The appropriate programmatic and administrative personnel of each organization involved in
this grant application are aware of the agency’s consortium agreement policy and are prepared
to establish the necessary inter-organizational agreement(s) consistent with that policy.
For more information:
Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more
information.
16. Resource Sharing
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Data Sharing Plan: Investigators seeking $500,000 or more in direct costs (exclusive of
consortium F&A) in any budget period 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 example
human subject concerns, the Small Business Innovation Development Act provisions, etc.).
Specific FOAs may require that all applications include this information regardless of the dollar
level. Applicants are encouraged to read the FOA carefully and discuss their data-sharing plan
with their program contact at the time they negotiate an agreement with the Institute/Center
(IC) staff to accept assignment of their application. For more information, see the NIH Data
Sharing Policy or the NIH Grants Policy Statement, Section 8.2.3.1: Data Sharing Policy.
Sharing Model Organisms: Regardless of the amount requested, all applications where the
development of model organisms is anticipated are expected to include a description of a specific
plan for sharing and distributing unique model organisms or state why such sharing is restricted
or not possible. For more information, see the NIH Grants Policy Statement, Section 8.2.3.2:
Sharing Model Organisms.
Genomic Data Sharing (GDS): Applicants seeking funding for research that generates large-
scale human or non-human genomic data are expected to provide a plan for sharing of these
data. Examples of large-scale genomic data include genome-wide association studies (GWAS),
single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic,
epigenomic, and gene expression data. Supplemental Information to the NIH GDS provides
examples of genomic research projects that are subject to the Policy. For more information, see
the NIH GDS Policy, the NIH Grants Policy Statement, Section 8.2.3.3: Genomic Data Sharing (GDS)
Policy/ Policy for Genome-Wide Association Studies (GWAS), and the GDS website.
Note on GDS: For proposed studies generating human genomic data under the scope of the
GDS Policy, an Institutional Certification may be submitted at the time of application submission,
but it is not required at that time. The Institutional Certification, however, will be requested as
Just-in-Time (JIT) information prior to award. The Institutional Certification, or in some cases, a
Provisional Institutional Certification, must be submitted and accepted before the award can be
issued.
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For more information:
NIH considers the sharing of unique research resources developed through NIH-sponsored
research an important means to enhance the value and further the advancement of the research.
When resources have been developed with NIH funds, and the associated research findings
published or provided to NIH, it is important that they be made readily available for research
purposes to qualified individuals within the scientific community. See the NIH Grants Policy
Statement, Section 8.2.3: Sharing Research Resources.
17. Authentication of Key Biological and/or Chemical Resources
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
If applicable to the proposed science, briefly describe methods to ensure the identity and validity
of key biological and/or chemical resources used in the proposed studies. A maximum of one
page is suggested.
More information:
Key biological and/or chemical resources are characterized as follows:
l Key biological and/or chemical resources may or may not have been generated with NIH
funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities
and/or qualifications that could influence the research data; and 3) are integral to the
proposed research. These include, but are not limited to, cell lines, specialty chemicals,
antibodies, and other biologics.
l Standard laboratory reagents that are not expected to vary do not need to be included
in the plan. Examples are buffers and other common biologicals or chemicals.
l See NIH's page on Rigor and Reproducibility for more information.
Appendix
18. Appendix
Refer to the FOA to determine whether there are any special appendix instructions for your
application. See the updated NIH Guide Notice on the Appendix Policy.
Format:
A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 allowable
appendix attachments are needed, combine the remaining information into attachment #10.
Use filenames for attachments that are descriptive of the content.
A summary sheet listing all of the items included in the Appendix is encouraged but not required.
When including a summary sheet, it should be included in the first appendix attachment.
Content:
The only allowable appendix materials are:
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l Blank data collection forms, blank survey forms, and blank questionnaire forms - or
screenshots thereof
l Simple lists of interview questions
Note: In your blank forms and lists, do not include items such as: data, data
compilations, lists of variables or acronyms, data analyses, publications, manuals,
instructions, descriptions or drawings/figures/diagrams of data collection methods or
machines/devices.
l Blank informed consent/assent forms
l Other items only if they are specified in the FOA as allowable appendix materials
No other items are allowed in the Appendix. Simply relocating disallowed materials to other parts
of the application will result in a noncompliant application.
Some FOAs may have different instructions for the Appendix. Always follow the instructions in
your FOA if they conflict with these instructions.
Note: Applications will be withdrawn and not reviewed if they do not follow the appendix
requirements in these instructions or in your FOA.
Information that expands upon or complements information provided in any section of the
application – even if it is not required for the review – is not allowed in the Appendix unless it is
listed in the allowed appendix materials above or in your FOA. For example, do not include
material transfer agreements (MTA) in the appendix unless otherwise specified in the FOA.
For more information:
l The NIH Guide Notice on Reminder: NIH Applications Must Be Complete and Compliant With
NIH Policy and Application Instructions At Time of Submission.
l Failure of reviewers to address non-required appendix materials in their reviews is not an
acceptable basis for an appeal of initial peer review. For more information, see the NIH Grants
Policy Statement, Section 2.4.2: Appeals of Initial Scientific Review.
l Appendix Policy Frequently Asked Questions
Citizenship
Information on Citizenship Requirements for CDA Applicants:
The candidate must be a citizen or non-citizen national of the United States or its possessions
and territories, or must have been lawfully admitted to the United States for permanent
residence by the time of award EXCEPT if any of the following apply:
l candidate is applying to the K99/R00 award program;
l candidate is applying to the K43 award program; or
l the FOA specifies otherwise.
Note for permanent residents: Before an award is issued, a permanent resident will be required
to submit a notarized statement that the candidate holds a current and valid Permanent
Resident Card or some other valid verification from the U.S. Immigration and Naturalization
Service of legal admission to the U.S. as a permanent resident.
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K.410 - PHS 398 Career Development Award Supplemental Form
Note for candidates whose citizenship status changes or is expected to change: For those
career development award programs that require candidates to be U.S. citizens or permanent
residents, an individual who has applied for permanent residence and expects to have obtained
such status prior to the time award may submit an application recognizing that no award will be
made until legal verification of permanent resident status is provided. If a candidate’s citizenship
status changes after submission of the application, the new status should be reported in the
candidate’s Personal Profile in the eRA Commons.
Note on K99/R00 applicants on temporary visas: It is the responsibility of the applicant
organization to determine and document in the application that the candidate’s visa will allow
him or her to remain in the U.S. long enough to complete the phase of the award (e.g., K99 or
R00) covered by the application. Information may be requested by the NIH or another PHS
Agency prior to issuance of an award as a Just-in-Time submission.
Check the applicable boxes for the following questions:
19. U.S. Citizen or Non-Citizen National?
Check “Yes” if the candidate is either a U.S. Citizen or a Non-Citizen national; otherwise check
“No.”
Non-Citizen nationals are people who, although not citizens of the United States, owe
permanent allegiance to the United States. They generally are people born in outlying
possessions of the United States (e.g., American Samoa and Swains Island).
If no, select most appropriate Non-U.S. Citizen option:
Please select the most appropriate response from the options provided.
With a Permanent U.S. Resident Visa:
Check this box if the candidate has been lawfully admitted for permanent residence (i.e., is in
the possession of a current and valid Permanent Resident Card or other legal verification of
such status). A notarized statement will be required as part of the pre-award process.
With a Temporary U.S. Visa:
Check this box if the candidate currently holds a temporary U.S visa. This box is applicable
only to specific programs that do not require U.S. citizenship or permanent residency (e.g.,
K99/R00).
Not Residing in the U.S.:
Check this box if the candidate is a citizen of a country other than the U.S. and plans to
pursue career development outside of the U.S. This box is applicable only to specific
programs (e.g., K43).
If you are a non-U.S. citizen with a temporary visa applying for an award that requires per-
manent residency status, and expect to be granted a permanent resident visa by the start
date of the award, check here:
Check this box to indicate that permanent resident status is pending (i.e., if the candidate is not a
U.S citizen but has applied for permanent residence and expects to hold a permanent resident
visa by the earliest possible start date of the award). A notarized statement will be required as a
part of the pre-award process. The statement must show that a licensed notary has seen the
career development applicant’s valid Permanent Resident Card (USCIS Form I-551) or other valid
verification from the U.S. Immigration and Naturalization Service of legal admission to the U.S.
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K.500 - PHS Human Subjects and Clinical Trials Information
K.500 - PHS Human Subjects and Clinical
Trials Information
The PHS Human Subjects and Clinical Trials Information
form is used to collect information on human subjects
research, clinical research, and/or clinical trials, including
study population characteristics, protection and
monitoring plans, and a protocol synopsis.
This form accommodates the full spectrum of all types of
clinical trials, including, but not limited to, behavioral,
exploratory/development, mechanistic, pilot/feasibility,
early phase, efficacy, effectiveness, group-randomized,
and others.
Read all the instructions in the Funding Opportunity
Announcement (FOA) before completing this form to
ensure your application meets all IC-specific criteria.
"Section II. Award Information" of the FOA will indicate
whether clinical trials are or are not allowed and
whether clinical trial research experience is or is not
allowed. The designation of your FOA will determine how to use these instructions, and
subsequently, how to fill out this form.
The PHS Human Subjects and Clinical Trials Information form, together with the rest of your
application, should include sufficient information for the evaluation of the project,
independent of any other documents (e.g., previous application). Be specific, describe each
study clearly, and avoid redundancies. Be especially careful to avoid redundancies with your
research strategy.
View larger image
Quick Links
PHS Human Subjects and Clinical Trials Information
Use of Human Specimens and/or Data
If No to Human Subjects
If Yes to Human Subjects
Other Requested Information
Study Record(s)
Delayed Onset Study(ies)
Study Record: PHS Human Subjects and Clinical Trials Information
Section 1 - Basic Information
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1.1 Study Title (each study title must be unique)
1.2 Is this Study Exempt from Federal Regulations?
1.3 Exemption Number
1.4 Clinical Trial Questionnaire
1.5 Provide the ClinicalTrials.gov Identifier (e.g. NCT87654321) for this trial, if applicable.
Section 2 - Study Population Characteristics
2.1 Conditions or Focus of Study
2.2 Eligibility Criteria
2.3 Age Limits
2.3.a Inclusion of Individuals Across the Lifespan
2.4 Inclusion of Women and Minorities
2.5 Recruitment and Retention Plan
2.6 Recruitment Status
2.7 Study Timeline
2.8 Enrollment of First Participant
2.9 Inclusion Enrollment Report(s)
Section 3 - Protection and Monitoring Plans
3.1 Protection of Human Subjects
3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human
subjects research at more than one domestic site?
3.3 Data and Safety Monitoring Plan
3.4 Will a Data and Safety Monitoring Board be appointed for this study?
3.5 Overall Structure of the Study Team
Section 4 - Protocol Synopsis
4.1 Study Design
4.2 Outcome Measures
4.3 Statistical Design and Power
4.4 Subject Participation Duration
4.5 Will the study use an FDA-regulated intervention?
4.6 Is this an applicable clinical trial under FDAAA?
4.7 Dissemination Plan
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
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Complete the PHS Human Subjects and Clinical Trials Information form after you have completed the
K.220 - R&R Other Project Information Form.
This form accommodates the full spectrum of all types of clinical trials, including, but not limited to,
exploratory/development, mechanistic, pilot/feasibility, early phase, efficacy, effectiveness, group-
randomized, and others.
Who should use the PHS Human Subjects and Clinical Trials Information form:
The designation of your FOA will determine how to use these instructions, and subsequently, how to
fill out this form.
All applicants must use the PHS Human Subjects and Clinical Trials Information form regardless of your
answer to the question “Are human subjects involved?” on the K.220 - R&R Other Project Information
Form.
Note for studies involving only the secondary use of identifiable biospecimens or data: For
studies where the only involvement of human subjects is the use of identifiable biospecimens or data
originally collected for another purpose, complete the PHS Human Subjects and Clinical Trials
Information form with information specific to the current study and not the original collection unless
the information associated with the original collection is pertinent to the proposed study. If
information about the original collection is necessary, provide context and clearly distinguish between
the current study and historical information.
Using the PHS Human Subjects and Clinical Trials Information form:
Everyone must complete the "Use of Human Specimens and/or Data" section of the PHS Human
Subjects and Clinical Trials Information form. However, your answer to the “Are human subjects
involved?” question will determine which other sections of the PHS Human Subjects and Clinical Trials
Information form you must complete. Once you have completed the "Use of Human Specimens and/or
Data" section, follow instructions on the form that are specific to your answer to the "Are human
subjects involved?" question on the K.220 - R&R Other Project Information Form:
l if you answered "Yes" to the question "Are human subjects involved?" on the K.220 - R&R
Other Project Information Form, see the "If Yes to Human Subjects" section for instructions.
l if you answered "No" to the question "Are human subjects involved?" on the K.220 - R&R
Other Project Information Form, see the "If No to Human Subjects" section for instructions.
The PHS Human Subjects and Clinical Trials Information form allows you to add Study Record(s) and/or
Delayed Onset Study(ies), as applicable.
Within each Study Record, you will add detailed information at the study level. Do not duplicate
studies within your application. Each study within the application should be unique and should have a
unique study title. Each Study Record is divided into numbered sections:
l Section 1 - Basic Information
l Section 2 – Study Population Characteristics (includes Inclusion Enrollment Report)
l Section 3 – Protection and Monitoring Plans
l Section 4 – Protocol Synopsis
l Section 5 – Other Clinical Trial-related Attachments
Note: The PHS Human Subjects and Clinical Trials Information form will capture detailed information at
the study level. Although you are encouraged to refer to information in the PHS Human Subjects and
Clinical Trials Information form in your discussion of the Research Strategy, do not duplicate
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information between the Research Strategy attachment and the PHS Human Subjects and Clinical
Trials Information form.
For more information on what a “study” is for the purposes of the PHS Human Subjects and Clinical
Trials Information form, see the relevant FAQ on the Applying Electronically FAQ page.
The PHS Human Subjects and Clinical Trials Information form is dynamic and may eliminate sections
that are not relevant to your application. The dynamic form behavior may not be enabled on all
submission methods.
Note: Some fields in this form match fields within ClinicalTrials.gov and are identified as such within
these instructions. Additional information about the fields can be found on the ClinicalTrials.gov
Protocol Registration Data Element Definitions website.
Additional Instructions for Career Development:
There are three primary situations by which K applicants can apply for human
subjects and/or clinical trial research.
Career Development Award (CDA) applicants who are not proposing a clinical
trial: Follow the standard instructions to complete the PHS Human Subjects and
Clinical Trials Information form.
CDA applicants who are proposing an independent clinical trial: Make sure you
are applying to a FOA that allows independent clinical trials (this is noted in
“Section II. Award Information” of the FOA). Follow the standard instructions to
complete the PHS Human Subjects and Clinical Trials Information form. (Note that
not every Study Record within your application has to be a clinical trial).
For more information on independent clinical trials, see:
l NIH Glossary definitions of Independent Clinical Trial and Ancillary Study
l NIH Definition of Clinical Trial Case Studies
l FAQ on Ancillary Studies
l FAQs on the Human Subjects and Clinical Trials Information form, including a
specific FAQ on K99/R00 applications.
l FAQs on Clinical Trial-specific FOAs, including a specific FAQ on K99/R00
applications.
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): You will generally follow the standard instructions to complete the
PHS Human Subjects and Clinical Trials Information form, but follow relevant Career
Development instructions where they are given. Make sure you are applying to a
FOA that allows Clinical Trial Research Experience (this is noted in “Section II. Award
Information” of the FOA). Additionally, the mentor or co-mentor is required to
include a statement to document leadership of the clinical trial. The statement
must include the following:
l Source of funding;
l ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable;
l A description of how your expertise is appropriate to guide the applicant in any
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proposed clinical trials research experience; and
l A statement/attestation that the mentor will be responsible for the clinical trial.
o
The mentor must have primary responsibility for leading and overseeing the
trial and must describe how she/he will provide this oversight (be careful
not to overstate the candidate’s responsibilities).
o
Include details on the specific roles/responsibilities of the applicant and
mentor, keeping in mind that the terms of a CDA award do not always
permit the candidate to lead a clinical trial.
This statement must be included in the “Plans and Statements of Mentor and Co-
Mentor(s)” attachment in the K.410 - PHS 398 Career Development Award
Supplemental Form.
Applicants must follow all policies and requirements related to formatting, proprietary
information, human subjects, and clinical trials. See the following pages for more information:
l Format Attachments
l Rules for Text Fields
l NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information
l NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act
l NIH's Human Subjects Research website
l NIH's Clinical Trials website
Note: There are no page limits for any attachments in the PHS Human Subjects and Clinical Trials
Information form.
PHS Human Subjects and Clinical Trials
Information
Applicants must complete the human subjects questions on the K.220 - R&R Other Project
Information Form prior to completing this form.
Use of Human Specimens and/or Data
Regardless of your answer to the question “Are Human Subjects Involved?” on the K.220
- R&R Other Project Information Form, answer the following question(s) about the use of
human specimens and/or human data.
Does any of the proposed research in the application involve human specimens and/or data?
Select “Yes” or “No” to indicate whether the proposed research involves human specimens
and/or data.
Note: Applications involving the use of human specimens or data may not be considered to be
research involving human subjects, depending on the details of the materials to be used.
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Provide an explanation for any use of human specimens and/or data not considered to be human
subjects research.
If you answered “No” to the “Does any of the proposed research in the application involve human
specimens and/or data?” question, you do not need to attach an explanation here.
If you answered “Yes” to the “Does any of the proposed research in the application involve
human specimens and/or data?” question, you must provide an explanation for any use of
human specimens and/or data not considered to be human subjects research. To help determine
whether your research is classified as human subjects research, refer to the Research Involving
Private Information or Biological Specimens flowchart. For any human specimens and/or data
that is considered human subjects research, you will add a Study Record. Do not duplicate the
information in your explanation in any of your Study Records.
Attach the explanation as a PDF file. See NIH’s Format Attachments page.
This explanation should include:
l information on who is providing the data/biological specimens and their role in the
proposed research;
l a description of the identifiers that will be associated with the human specimens and
data;
l a list of who has access to subjects’ identities; and
l information about the manner in which the privacy of research participants and
confidentiality of data will be protected.
Please complete the human subjects section of the Research & Related Other
Project Information form prior to completing this form.
Are Human Subjects Involved? Yes/No
This field is pre-populated from the K.220 - R&R Other Project Information Form. If the value in
this field appears to be incorrect, you may correct it by adjusting it on the K.220 - R&R Other
Project Information Form.
Is the Project Exempt from Federal regulations? Yes/No
This field is pre-populated from the K.220 - R&R Other Project Information Form. If the value in
this field appears to be incorrect, you may correct it by adjusting it on the K.220 - R&R Other
Project Information Form.
Exemption number: 1, 2, 3, 4, 5, 6, 7, 8
This field is pre-populated from the K.220 - R&R Other Project Information Form. If the value in
this field appears to be incorrect, you may correct it by adjusting it on the K.220 – R&R Other
Project Information Form.
Note: If you change your answer to the “Are Human Subjects Involved” question on the K.220 - R&R
Other Project Information Form after you have started entering information into the PHS Human
Subjects and Clinical Trials Information form, your data in the PHS Human Subjects and Clinical Trials
Information form may be lost.
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If No to Human Subjects
If you answered "No" to the question “Are Human Subjects Involved?” on the K.220 - R&R
Other Project Information Form, skip the rest of the PHS Human Subjects Clinical Trials
Information form unless otherwise directed by your FOA.
If Yes to Human Subjects
If you answered “Yes” to the question “Are Human Subjects Involved?” on the K.220 - R&R
Other Project Information Form, add a Study Record for each proposed study involving
human subjects by selecting “Add New Study” or “Add New Delayed Onset Study,” as
appropriate.
Other Requested Information
Who may provide Other Requested Information:
Follow the instructions below and any instructions in your FOA to determine whether you are
permitted to include the “Other Requested Information” attachment.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Content is limited to what is described in your FOA or in these instructions. Do not use the
“Other Requested Information” attachment to include any other information.
Renewal applications: When preparing a renewal (or resubmission of a renewal), you can
provide a list of ongoing studies or ClinicalTrials.gov identifiers (e.g., NCT87654321).
Study Record(s)
Adding Study Record Attachment(s):
Add a study record for each proposed study involving human subjects. If specific plans for your
study involving human subjects can be described in the application but will not begin
immediately (i.e., your study has a delayed start), you must add a Study Record for that study. If
your study anticipates involving human subjects within the period of award but specific plans
cannot be described in the application (i.e., delayed onset), see the instructions for Delayed
Onset Study(ies).
For all submission methods, the Study Record is used to collect human subjects study data.
Note: The steps to add a Study Record attachment(s) may vary with the submission method. For
example, from the ASSIST Human Subjects and Clinical Trials tab, use the ‘Add New Study’ button
to access the data entry screens to enter Study Record information directly into ASSIST. With
other submission methods, you may have to extract a blank copy of the Study Record, complete it
offline, and then attach it to your application.
Note on Grouping Studies into Study Records: While there may be more than one way to split
or group studies into Study Records, you are encouraged to group studies that use the same
human subjects population and same research protocols into a single Study Record, to the
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extent that the information you provide is accurate and understandable to NIH staff and
reviewers.
If information in any attachment is identical across studies, include the complete information only
in the first Study Record for which the information is relevant. In the subsequent Study Records
for which the identical information is needed, upload an attachment that says, “See information
for attachment X in Study Record entitled [include study title]." No other information is needed in
the attachment. Do not submit attachments that are duplicated from one Study Record to
another. Note that you should not name Study Records by number. Examples of attachments
that may be identical across studies include, but are not limited to, the 3.1 Protection of Human
Subjects and 3.5 Overall Structure of the Study Team attachments.
See the NIH Glossary definitions of Study and Study Record.
The PHS Human Subjects and Clinical Trials Information form accommodates up to 150 separate
Study Records.
Format:
All attachments must be PDF files. If you extract a Study Record, it will already be in a fillable PDF
format. Please use this PDF file and do not alter the format of the Study Record file. Use unique
filenames for each human subject study record. The filename for each attachment within a study
must be unique within the application (i.e., do not use the same filename in multiple Study
Records).
Content:
Follow the instructions in the “Study Record: PHS Human Subjects and Clinical Trials Information”
section below.
Delayed Onset Study(ies)
If you anticipate conducting research involving human subjects but cannot describe the study at
the time of application (i.e., your study is a delayed onset human subject study), enter a Delayed
Onset Study Record as instructed below.
Generally, for any study that you include as a delayed onset study in this section, you will provide
a study title, indicate whether the study is anticipated to include a clinical trial, and include a
justification attachment. Since by definition, information for a delayed onset study is not available
at the time of application, you will not be given the option to complete a full Study Record for a
delayed onset study. For delayed onset studies, the Delayed Onset Study Record is sufficient.
Notes on delayed onset studies:
l Delayed onset does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start). Refer to the NIH Glossary definition of Delayed Onset
Study and Delayed Start.
l If you anticipate multiple delayed onset studies, you can include them together in a
single Delayed Onset Study Record.
Study Title
This field is required.
The Study Title can have a maximum of 600 characters.
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Enter a brief, unique title that describes the study the participants will be involved in. Each study
within your application must have a unique Study Title. The first 150 characters will display in the
application image bookmarks.
Note on multiple delayed onset studies: If you are including multiple delayed onset studies in
one delayed onset study entry, you may enter “Multiple Delayed Onset Studies” as the title of this
record.
Anticipated Clinical Trial?
This field is required.
Check this box if you anticipate that this study will be a clinical trial. For help determining whether
your study meets the definition of clinical trial, see the Clinical Trial Questionnaire below.
Read your FOA carefully to determine whether clinical trials are allowed in your application.
Note on multiple delayed onset studies: If you are including multiple delayed onset studies in
one delayed onset study entry, and you anticipate that any of these studies will be a clinical trial,
check the “Anticipated Clinical Trial?” checkbox.
Additional Instructions for Career Development:
Career Development Award (CDA) applicants who are not proposing a clinical
trial: Follow the standard instructions.
CDA applicants who are proposing an independent clinical trial: Follow the
standard instructions.
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not check the “Anticipated Clinical Trial?” box.
Justification Attachment
This attachment is required.
Attach the justification as a PDF file. See NIH’s Format Attachments page.
l All delayed onset studies must provide a justification explaining why human subjects
study information is not available at the time of application.
l
If NIH’s Single Institutional Review Board (sIRB) policy will apply to your study, this
justification must also include information regarding how the study will comply with the
policy. The applicant must provide a statement naming the sIRB of record in the Just-in-
Time submission prior to award.
l If NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information will apply to
your study, this justification must also include the dissemination plan.
Note on multiple delayed onset studies: If you are including more than one delayed onset
study in any given delayed onset study entry, address all the included studies in a single
justification attachment.
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Study Record: PHS Human Subjects and Clinical
Trials Information
Section 1 - Basic Information
Who must complete “Section 1 – Basic Information:”
“Section 1 – Basic Information” is required for all studies involving human subjects.
1.1 Study Title (each study title must be unique)
The “Study Title” field is required.
The Study Title can have a maximum of 600 characters.
Enter a brief title that describes the study the participants will be involved in. If there is more than
one study (i.e., you are including more than one Study Record and/or delayed onset study in your
application), each one must have a unique study title. The first 150 characters will display in the
bookmarks of the application image.
Note: When registering a clinical trial in ClinicalTrials.gov, all study titles across your organization
must be unique.
Note: This field matches a ClinicalTrials.gov field (Official Title).
1.2 Is this Study Exempt from Federal Regulations?
An answer to the “Is this Study Exempt from Federal Regulations?” question is required.
Indicate whether the study is exempt from Federal regulations for the Protection of Human
Subjects.
For more information, see the NIH's Definition of Human Subjects Research website.
1.3 Exemption Number
The “Exemption Number” field is required if you selected “Yes” to the “Is this Study Exempt from
Federal Regulations?” question.
Select the appropriate exemption number(s) for this particular study. Multiple selections are
permitted. Regardless of whether these exemptions may apply to you in the future, you must fill
out your application following the instructions below.
For more information:
The categories of research that qualify for exemption are defined in the Common Rule for the
Protection of Human Subjects. These regulations can be found at 45 CFR 46.
Need help determining the appropriate exemption number?
l Refer to NIH's Human Subjects FAQs.
l See the NIH's Human Subjects Frequently Asked Questions section on Exemptions.
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The Office of Human Research Protections (OHRP) guidance states that appropriate use of
exemptions described in 45 CFR 46 should be determined by an authority independent from the
investigators (for more information, see OHRP's Frequently Asked Questions). Institutions often
designate their Institutional Review Board (IRB) to make this determination. Because NIH does
not require IRB approval at the time of application, the exemptions designated often represent
the opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is
evaluated during peer review.
1.4 Clinical Trial Questionnaire
The Clinical Trial Questionnaire is required.
Note for basic and mechanistic studies involving human participants: The NIH definition of a
clinical trial encompasses a broad range of studies, including studies using human participants
that aim to understand fundamental aspects of phenomena, the pathophysiology of a disease,
or the mechanism of action of an intervention. This includes many mechanistic studies and
studies submitted to Basic Experimental Studies with Humans FOAs.
Answer “Yes” or “No” to the following questions to determine whether this study involves a
clinical trial. Answer the following questions based only on the study you are describing in this
Study Record.
Note: The answer to question “1.4.a Does the study involve human participants?” will be pre-
populated with “Yes” for all study records. You will not be able to change this answer.
1.4.a. Does the study involve human participants? Yes/No
1.4.b. Are the participants prospectively assigned to an intervention? Yes/No
1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?
Yes/No
1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral out-
come? Yes/No
If you answered “Yes” to all the questions in the Clinical Trial Questionnaire, this study meets the
definition of a clinical trial.
Refer to the table below for information about what sections of this form are required, based on
your answers to Question 1.4 "Clinical Trial Questionnaire."
Form Section
If you answered "yes"
to all the questions in
the Clinical Trial
Questionnaire
If you answered "no"
to any of the questions
in the Clinical Trial
Questionnaire
Section 2 - Study Population
Characteristics
Required
Required
Section 3 - Protection and
Monitoring Plans
Required
Required
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Form Section
If you answered "yes"
to all the questions in
the Clinical Trial
Questionnaire
If you answered "no"
to any of the questions
in the Clinical Trial
Questionnaire
Section 4 - Protocol Synopsis
Required
Do not complete
Section 5 - Other Clinical Trial-
related Attachments
Required if specified in the
FOA
Do not complete
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Even if you answered “Yes” to all the questions in the Clinical Trial
Questionnaire, only certain fields of the PHS Human Subjects and Clinical Trials
Information form are required (and other fields are not allowed) because the study
is not an independent clinical trial. Do not provide information in “Section 4 –
Protocol Synopsis” or in “Section 5 – Other Clinical Trial-related Attachments” of the
Study Record. Inputting information into these sections will result in errors and will
prevent your application from being accepted.
You will generally follow the standard instructions to complete the PHS Human
Subjects and Clinical Trials Information form, but follow relevant Career
Development instructions where they are given.
For more information:
l NIH Glossary’s definition of an NIH-defined clinical trial
l NIH's Definition of a Clinical Trial page
l NIH Definition of Clinical Trials Case Studies page
l FAQs on the NIH Clinical Trial Definition
l NIH’s decision tool will help determine whether your human subjects research study is
an NIH-defined clinical trial
l Your study may also be subject to additional regulations. Read NIH’s Requirements for
Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov.
1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if
applicable
If a clinical trial has already been entered into ClinicalTrials.gov, enter the ClinicalTrials.gov
identifier (e.g., NCT87654321) for this trial. Enter the identifier only if you are proposing to work
on that specific clinical trial. If you are only getting samples and/or data from a clinical trial that
has already been entered into ClinicalTrials.gov, do NOT enter the identifier.
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If you are building on an existing study (e.g., ancillary study), enter the ClinicalTrials.gov identifier
only for the ancillary study (if registered separately), not the parent study.
Note: The number you enter in this field should match the ClinicalTrials.gov identifier assigned by
ClinicalTrials.gov.
Section 2 - Study Population Characteristics
Who must complete “Section 2 - Study Population Characteristics:”
All of “Section 2 – Study Population Characteristics” is required (see exceptions for Question 2.7 Study
Timeline and for Question 2.8 Enrollment of First Subject) for all human subjects studies unless the
following applies to you:
l If you selected only Exemption 4 and no other exemptions on the "1.3 Exemption Number"
question, then “Section 2 – Study Population Characteristics” is not required.
2.1 Conditions or Focus of Study
At least 1 entry is required, and up to 20 entries are allowed (enter each entry on its own line).
Each entry is limited to 255 characters.
Identify the name(s) of the disease(s) or condition(s) you are studying, or the focus of the study. If
available, use appropriate descriptors from NLM's Medical Subject Headings (MeSH) so the
application can be categorized. Include an entry for each condition.
Note: This field matches a ClinicalTrials.gov field (Primary Disease or Condition Being Studied in
the Trial, or the Focus of the Study).
2.2 Eligibility Criteria
List the study’s inclusion and exclusion criteria. To provide a bulleted list, use a dash (or other
character) followed by a space (“- “) at the start of each bullet. Be sure to check the formatting in
the assembled application image. Further explanation or justification should be included in the
Recruitment and Retention plan.
Your text entry is limited to 15,000 characters (but typically needs only 500 characters).
Note: This field matches a ClinicalTrials.gov field (Eligibility Criteria).
For more information about formatting text entry fields, see NIH's Rules for Text Fields page and
the ClinicalTrials.gov's Protocol Registration and Results System User's Guide.
2.3 Age Limits
Minimum Age
Enter the numerical value for the minimum age a potential participant can be to be eligible for
the study. Provide the relevant units of time (i.e., years, months, weeks, days, hours, or minutes). If
there is no lower limit or no lower limit is known, enter “N/A (No Limit)” and do not enter a unit of
time.
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Maximum Age
Enter the numerical value for the maximum age a potential participant can be to be eligible for
the study. Provide the relevant units of time (i.e., years, months, weeks, days, hours, or minutes). If
there is no upper limit or no upper limit is known, enter “N/A (No Limit)” and do not enter a unit
of time.
Note: This field matches a ClinicalTrials.gov field (Age Limits).
2.3.a Inclusion of Individuals Across the Lifespan
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Discuss each of the points listed below. Also include any additional information requested in the
FOA.
You will also have to complete an Inclusion Enrollment Report (IER). Note that you may need to
include multiple IERs for each study. Refer to the instructions for the IER below for more
information.
Inclusion of Individuals Across the Lifespan
For the purposes of the Inclusion of Individuals Across the Lifespan, exclusion of any specific age
or age range group (e.g., children or older adults) should be justified in this section. In addition,
address the following points:
l Individuals of all ages are expected to be included in all NIH-defined clinical research
unless there are scientific or ethical reasons not to include them. Discuss whether
individuals will be excluded based on age and provide a rationale for the minimum and
maximum age of study participants, if applicable. Additionally, if individuals will be
excluded based on age, provide a scientific or ethical rationale for their exclusion. See the
NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as
Participants in Research Involving Human Subjects for additional information about
circumstances that may justify the exclusion of individuals based on age.
l Include a description of the expertise of the investigative team for working with
individuals of the ages included, the appropriateness of the available facilities to
accommodate individuals in the included age range, and how the age distribution of
participants will contribute to a meaningful analysis relative to the purpose of the study.
When children are involved in research, the policies under HHS’ 45 CFR 46, Subpart D - Additional
Protections for Children Involved as Subjects in Research apply and must be addressed in the
Protection of Human Subjects attachment.
Existing Datasets or Resources. If you will use an existing dataset, resource, or samples that may
have been collected as part of a different study, you must address inclusion, following the
instructions above. Generally, you must provide details about the sex/gender, race, and ethnicity
of the existing dataset/resource and justify the details as appropriate to the scientific goals of the
proposed study.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Monitoring Inclusion When Working with Existing Datasets and/or
Resources.
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For more information, see:
l NIH Policy Implementation Page on Inclusion Across the Lifespan
l Inclusion Across the Lifespan: Guidance for Applying the Policy infographic
l NIH FAQs on Inclusion Across the Lifespan
l HHS’ 45 CFR 46 Subpart D – Additional Protections for Children
l NIH Grants Policy Statement, Section 4.1.15.7: Inclusion of Individuals Across the Lifespan
as Participants in Research Involving Human Subjects
2.4 Inclusion of Women and Minorities
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Discuss each of the points listed below and include any additional information requested in the
FOA.
You will also have to complete an Inclusion Enrollment Report (IER). Note that you may need to
include multiple IERs for each study. Refer to the instructions for the IER below for more
information.
Inclusion of Women and Minorities
Address the following points:
l Describe the planned distribution of subjects by sex/gender, race, and ethnicity.
l Describe the rationale for selection of sex/gender, racial, and ethnic group members in
terms of the scientific objectives and proposed study design. The description may
include, but is not limited to, information on the population characteristics of the
disease or condition under study.
l Describe proposed outreach programs for recruiting sex/gender, racial, and ethnic
group members.
l Inclusion and Excluded Groups: Provide a reason for limiting inclusion of any group by
sex/gender, race, and/or ethnicity. In general, the cost of recruiting certain groups
and/or geographic location alone are not acceptable reasons for exclusion of particular
groups. See the Inclusion of Women and Minorities as Participants in Research Involving
Human Subjects - Policy Implementation Page for more information.
Existing Datasets or Resources. If you will use an existing dataset, resource, or samples that may
have been collected as part of a different study, you must address inclusion, following the
instructions above. Generally, you must provide details about the sex/gender, race, and ethnicity
of the existing dataset/resource and justify the details as appropriate to the scientific goals of the
proposed study.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Monitoring Inclusion When Working with Existing Datasets and/or
Resources.
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NIH-Defined Phase III Clinical Trials. If the proposed research includes an NIH-Defined Phase
III Clinical Trial, the “Inclusion of Women and Minorities” attachment MUST address plans for how
sex/gender, race, and ethnicity will be taken into consideration in the design and valid analysis of
the trial. See the instructions for “Valid Analysis” and “Plans to test for Differences in Effect among
Sex/gender, Racial, and/or Ethnic Groups” below.
Additional information about valid analysis is available on the NIH Policy and Guidelines on The
Inclusion of Women and Minorities as Subjects in Clinical Research page.
Valid Analysis (for NIH-Defined Phase III Clinical Trials only):
Address the following issues for ensuring valid analyses:
l Inclusive eligibility criteria – in general, the cost of recruiting certain groups and/or
geographic location alone are not acceptable reasons for exclusion of particular
groups;
l Allocation of study participants of both sexes/genders and from different racial
and/or ethnic groups to the intervention and control groups by an unbiased process
such as randomization;
l Unbiased evaluation of the outcome(s) of study participants; and
l Use of unbiased statistical analyses and proper methods of inference to estimate and
compare the intervention effects by sex/gender, race, and/or ethnicity, particularly if
prior evidence strongly suggests that such differences exist.
Plan to Test for Differences in Effect among Sex/gender, Racial, and/or Ethnic Groups (for NIH-
Defined Phase III Clinical Trials only):
Applicants also should address whether they plan to test for differences in effect among
sex/gender, racial, and/or ethnic groups and why such testing is or is not appropriate.
This plan must include selection and discussion of one of the following analysis plans:
l Plans to conduct analyses to detect significant differences in intervention effect
among sex/gender, racial, and/or ethnic subgroups when prior studies strongly
support these significant differences among one or more subgroups, or
l Plans to include and analyze sex/gender, racial, and/or ethnic subgroups when prior
studies strongly support no significant differences in intervention effect between
subgroups. (Representation of sex/gender, racial, and ethnic groups is not required
as subject selection criteria, but inclusion is encouraged.), or
l Plans to conduct valid analyses of the intervention effect in sex/gender, racial, and/or
ethnic subgroups (without requiring high statistical power for each subgroup) when
the prior studies neither support nor negate significant differences in intervention
effect among subgroups.
For more information, see:
l NIH's Policy Implementation Page on the Inclusion of Women and Minorities
l HHS’ 45 CFR 46 Subpart B – Additional Protections for Pregnant Women, Fetuses, and
Neonates
l NIH Grants Policy Statement, Section 4.1.15.8: Inclusion of Women and Minorities as
Subjects in Clinical Research and Reporting Sex/Gender, Racial, and Ethnic Participation
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2.5 Recruitment and Retention Plan
Who must complete the "Recruitment and Retention Plan" attachment:
The “Recruitment and Retention Plan” attachment is required unless the following applies to you:
l You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Describe how you will recruit and retain participants in your study. You should address both
planned recruitment activities as well as proposed engagement strategies for retention.
2.6. Recruitment Status
Who must complete the "Recruitment Status" question:
The “Recruitment Status” question is required unless the following applies to you:
l You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.
Content:
From the dropdown menu, select the "Recruitment Status" that best describes the proposed
study, based upon the status of the individual sites. If any facility in a multi-site study has an
individual site status of “recruiting,” then choose “recruiting” for this question. Only one selection
is allowed. Choose from the following options:
l Not yet recruiting
l Recruiting
l Enrolling by invitation
l Active, not recruiting
l Completed
l Suspended
l Terminated (Halted Prematurely)
l Withdrawn (No Participants Enrolled)
Note: This field matches a ClinicalTrials.gov field (Overall Recruitment Status).
2.7. Study Timeline
Who must complete the "Study Timeline" attachment:
The “Study Timeline” attachment is required if you answered "Yes" to all the questions in the
"Clinical Trial Questionnaire" (i.e., your study is a clinical trial).
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The "Study Timeline" attachment is optional if either of the following apply to you:
l You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.
l You answered "No" to any of the questions in the "Clinical Trial Questionnaire" (i.e., your
study is not a clinical trial).
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Provide a description or diagram describing the study timeline. The timeline should be general
(e.g., "one year after notice of award"), and should not include specific dates.
Note: Additional milestones or timelines may be requested as just-in-time information or post-
award.
2.8. Enrollment of First Participant
Who must complete the "Enrollment of First Participant" question:
Do not complete this field if you will answer "Yes" to the question "Using an Existing Dataset or
Resource" in the Inclusion Enrollment Report.
The “Enrollment of First Participant” question is otherwise required unless the following applies
to you:
l You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.
Content:
Enter the date (MM/DD/YYYY) of the enrollment of the first participant into the study. From the
dropdown menu, select whether this date is anticipated or actual.
2.9. Inclusion Enrollment Report(s)
Who must complete the Inclusion Enrollment Report(s):
An Inclusion Enrollment Report is required for all human subjects studies unless, on Question 1.3
“Exemption Number,” you selected only Exemption 4 and no other exemptions.
Using the Inclusion Enrollment Report:
Each proposed study, unless it falls under Exemption 4, must contain at least one Inclusion Enrollment
Report (IER). However, more than one IER per study is allowed.
Once you have added an IER for a given study, you may edit, remove, or view it.
Note: You can add a maximum of 20 IERs per Study Record. These can be a combination of planned
and cumulative reports.
Multi-site studies: Generally, if the application includes a study recruiting subjects at more than one
site/location, investigators may create one IER or separate, multiple IERs to enable reporting by study
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or by site, depending on the scientific goals of the study and whether monitoring of inclusion
enrollment would benefit from being combined or separated. At a minimum, participants enrolled at
non-U.S. sites must be reported separately from participants enrolled at U.S. sites, even if they are part
of the same study. Please review the FOA to determine whether there are any other specific
requirements about how to complete the IER.
Duplicative Inclusion Reports: It is important that the IER for a given study be associated with only
one application and be provided only once in a given application (e.g., do not submit the same IER on
both the data coordinating center and the research site). If submitting individual application(s) as part
of a network or set of linked applications, please provide the IER with the individual site applications
unless otherwise directed by the FOA.
Renewal applications: When preparing a renewal (or resubmission of a renewal), investigators should
provide a narrative description regarding the cumulative enrollment from the previous funding period
(s) as part of the progress report section of the research strategy attachment in the application. The
IER should NOT be used for this purpose. If a given study will continue with the same enrollment or
additional enrollment, or if new studies are proposed, provide a new IER for each as described in the
instructions below.
Resubmission applications: If IERs were provided in the initial submission application, and if those
studies will be part of the resubmission application, complete the IER and submit again with the
resubmission application, regardless of whether the enrollment has changed or not. Also, provide any
new (additional) IERs.
Revision applications: Provide an IER if new studies are planned as part of the Revision and they meet
the NIH definition for clinical research.
For more information:
Refer to the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects -
Policy Implementation Page.
1. Inclusion Enrollment Report Title
The “Inclusion Enrollment Report Title” field is required.
The “Inclusion Enrollment Report title can have a maximum of 600 characters.
Enter a unique title for each IER. The title should indicate specific criteria that uniquely identify
each report. If the Project Title is pre-populated, you may edit it so that each IER title is unique.
2. Using an Existing Dataset or Resource?
The “Using an Existing Dataset or Resource” question is required.
If the study involves analysis of an existing dataset or resource (e.g., biospecimens) only, answer
“Yes” to this question. If the study involves prospective recruitment or new contact with
participants answer “No” to this question. Use separate IERs for studies involving use of existing
datasets or resources only and for studies that involve prospective recruitment or new contact
with study participants.
For additional guidance on what is considered an existing dataset, refer to the NIH FAQs on
Monitoring Inclusion When Working with Existing Datasets and/or Resources.
3. Enrollment Location Type (Domestic/Foreign)
The “Enrollment Location Type” field is required.
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Select whether the participants described in the IER are based at a U.S. (Domestic) or at a non-
U.S. (Foreign) site. Participants at U.S. and non-U.S. sites must be reported separately (i.e., on
separate IERs), even if it is for the same study.
For additional guidance on how to complete the IER if you will be working with non-U.S.
populations, refer to these FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.
4. Enrollment Country(ies)
The “Enrollment Country(ies)” field is optional.
Indicate the country or countries in which participants will be enrolled. Multiple U.S. sites can be
reported together in one IER. Foreign countries can be reported together in one IER. However,
you must use separate IERs for U.S. and non-U.S. sites. You can add up to 200 countries per IER.
5. Enrollment Location(s)
The “Enrollment Location(s)” field is optional.
Indicate the type of enrollment location (e.g., hospital, university, or research center), not the
name of the enrollment location.
Enrollment locations are typically where the research is conducted, and can be different from the
recruitment site.
6. Comments
Your comments are limited to 500 characters.
Enter information you wish to provide about this IER. This includes, but is not limited to,
addressing information about distinctive subpopulations if relevant to the scientific hypotheses
being studied. If inclusion monitoring is conducted on another study or NIH grant (e.g., data
coordinating center or research site), please indicate here.
Revision applications: If there are no updates to the IER(s) in your original grant application, do
not include an IER in your Revision application. Instead, provide a comment in this field to the
effect that previous IER(s) are still applicable. If you are revising the IER(s) in your original grant
application, provide a comment here to that effect.
Planned
Who must complete planned enrollment tables:
All studies must enter planned enrollment counts unless your proposed study will use only an
existing dataset or resource. Planned enrollment generally means that individuals will be
recruited into the study and/or that individuals have already been recruited and continue to be
part of the study.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.
For more information on racial categories, see the NIH Glossary definition of Racial Categories.
For more information on ethnic categories, see the NIH Glossary definition of Ethnic Categories.
Racial Categories
American Indian/Alaska Native:
These fields are required.
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Enter the expected number of females and males (in the respective fields) who are both American
Indian/Alaska Native and Not Hispanic or Latino. Enter the expected number of females and
males (in the respective fields) who are both American Indian/Alaska Native and Hispanic or
Latino.
Asian:
These fields are required.
Enter the expected number of females and males (in the respective fields) who are both Asian
and Not Hispanic or Latino. Enter the expected number of females and males (in the respective
fields) who are both Asian and Hispanic or Latino.
Native Hawaiian or Other Pacific Islander:
These fields are required.
Enter the expected number of females and males (in the respective fields) who are both Native
Hawaiian or Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of
females and males (in the respective fields) who are both Native Hawaiian or Other Pacific
Islander and Hispanic or Latino.
Black or African American:
These fields are required.
Enter the expected number of females and males (in the respective fields) who are both Black or
African American and Not Hispanic or Latino. Enter the expected number of females and males (in
the respective fields) who are both Black or African American and Hispanic or Latino.
White:
These fields are required.
Enter the expected number of females and males (in the respective fields) who are both White
and Not Hispanic or Latino. Enter the expected number of females and males (in the respective
fields) who are both White and Hispanic or Latino.
More than One Race:
These fields are required.
Enter the expected number of females and males (in the respective fields) who both identify with
more than one racial category and are Not Hispanic or Latino. Enter the expected number of
females and males (in the respective fields) who both identify with more than one racial category
and are Hispanic or Latino.
Total:
The total fields at the bottom will be automatically calculated and reflect the totals of all racial
categories for females, males, and individuals of unknown/not reported sex/gender who are Not
Hispanic or Latino and of all racial categories for females, males, and individuals of unknown/not
reported sex/gender who are Hispanic or Latino. The “Total” fields in the right column will be
automatically calculated to total all individuals.
Cumulative (Actual)
Who must complete cumulative (actual) enrollment tables:
You must enter cumulative enrollment counts if your proposed study will use an existing dataset
or resource.
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For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.
For more information on racial categories, see the NIH Glossary definition of Racial Categories.
For more information on ethnic categories, see the NIH Glossary definition of Ethnic Categories.
Racial Categories
American Indian/Alaska Native:
These fields are required.
Enter the number of females and males (in the respective fields) who are both American
Indian/Alaska Native and Not Hispanic or Latino. Enter the number of females and males (in the
respective fields) who are both American Indian/Alaska Native and Hispanic or Latino. Use the
“Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity is unknown).
Asian:
These fields are required.
Enter the number of females and males (in the respective fields) who are both Asian and Not
Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who
are both Asian and Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e.,
race and/or ethnicity is unknown).
Native Hawaiian or Other Pacific Islander:
These fields are required.
Enter the number of females and males (in the respective fields) who are both Native Hawaiian or
Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of females and
males (in the respective fields) who are both Native Hawaiian or Other Pacific Islander and
Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity
is unknown).
Black or African American:
These fields are required.
Enter the number of females and males (in the respective fields) who are both Black or African
American and Not Hispanic or Latino. Enter the expected number of females and males (in the
respective fields) who are both Black or African American and Hispanic or Latino. Use the
“Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity is unknown).
White:
These fields are required.
Enter the number of females and males (in the respective fields) who are both White and Not
Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who
are both White and Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e.,
race and/or ethnicity is unknown).
More than One Race:
These fields are required.
Enter the number of females and males (in the respective fields) who both identify with more
than one racial category and are Not Hispanic or Latino. Enter the expected number of females
and males (in the respective fields) who both identify with more than one racial category and are
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Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity
is unknown).
Unknown or Not Reported:
These fields are required.
Enter the number of females, males, and individuals of unknown/not reported sex/gender (in the
respective fields) whose race is unknown/not reported and who are Not Hispanic or Latino. Enter
the number of females, males, and individuals of unknown/not reported sex/gender (in the
respective fields) whose race is unknown/not reported and who are Hispanic or Latino. Enter the
number of females, males, and individuals of unknown/not reported sex/gender (in the
respective fields) who are both of unknown/not reported race and of unknown/not reported
ethnicity. Use the “Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity is
unknown).
Total:
The total fields at the bottom will be automatically calculated and reflect the totals of all racial
categories for females, males, and individuals of unknown/not reported sex/gender who are Not
Hispanic or Latino and of all racial categories for females, males, and individuals of unknown/not
reported sex/gender who are Hispanic or Latino. Use the “Unknown/Not Reported” fields as
needed (i.e., race and/or ethnicity is unknown). The “Total” fields in the right column will be
automatically calculated to total all individuals.
Section 3 – Protection And Monitoring Plans
Who must complete “Section 3 – Protection and Monitoring Plans:”
All of “Section 3 – Protection and Monitoring Plans” is required for all studies involving human
subjects, unless otherwise noted.
3.1 Protection of Human Subjects
The “Protection of Human Subjects” attachment is required.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Do not use the “Protection of Human Subjects” attachment to circumvent the page limits of the
Research Strategy.
For Human Subjects Research Claiming Exemptions: If you are claiming that your human
subjects research falls under any exemptions, justify why the research meets the criteria for the
exemption(s) that you have claimed. This justification should explain how the proposed research
meets the criteria for the exemption claimed. Do not merely repeat the criteria or definitions
themselves.
For Studies that involve Non-Exempt Human Subjects Research: For any proposed non-
exempt study involving human subjects, NIH requires a Protection of Human Subjects
attachment that is commensurate with the risks of the study, its size, and its complexity. Organize
your attachment into four sections, following the headings and specified order below, and
discuss each of the points listed below. Start each section with the appropriate section heading –
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Risks to Human Subjects, Adequacy of Protection Against Risks, Potential Benefits of the
Proposed Research to Research Participants and Others, and Importance of the Knowledge to be
Gained. Also include any additional information requested in the FOA.
1. Risks to Human Subjects
a. Human Subjects Involvement, Characteristics, and Design
l Briefly describe the overall study design.
l Describe the subject population(s) to be included in the study; the procedures for assignment
to a study group, if relevant; and the anticipated numbers of subjects for each study group.
l List any collaborating sites where human subjects research will be performed, and describe
the role of those sites and collaborating investigators in performing the proposed research.
b. Study Procedures, Materials, and Potential Risks
l Describe all planned research procedures (interventions and interactions) involving study
subjects; how research material, including biospecimens, data, and/or records, will be
obtained; and whether any private identifiable information will be collected in the proposed
research project.
l For studies that will include the use of previously collected biospecimens, data or records,
describe the source of these materials, whether these can be linked with living individuals,
and who will be able to link the materials.
l Describe all the potential risks to subjects associated with each study intervention, procedure
or interaction, including physical, psychological, social, cultural, financial, and legal risks; risks
to privacy and/or confidentiality; or other risks. Discuss the risk level and the likely impact to
subjects.
l Where appropriate, describe alternative treatments and procedures, including their risks and
potential benefits. When alternative treatments or procedures are possible, make the
rationale for the proposed approach clear.
2. Adequacy of Protection Against Risks
a. Informed Consent and Assent
l Describe the process for obtaining informed consent. Include a description of the
circumstances under which consent will be sought and obtained, who will seek it, the nature
of the information to be provided to prospective subjects, and the method of documenting
consent. When appropriate, describe how potential adult subjects’ capacity to consent will be
determined and the plans for obtaining consent from a legally authorized representative for
adult subjects not able to consent.
o
For research involving children: If the proposed studies will include children, describe
the process for meeting HHS regulatory requirements for parental permission and child
assent (45 CFR 46.408). See the HHS page on Research with Children FAQs and the NIH
page on Requirements for Child Assent and Parent/Guardian Permission.
l If a waiver of some or all of the elements of informed consent will be sought, provide
justification for the waiver. Do not submit informed consent document(s) with your
application unless you are requested to do so.
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b. Protections Against Risk
l Describe planned strategies for protecting against or minimizing all potential risks identified,
including strategies to manage and protect the privacy of participants and confidentiality of
research data.
l Where appropriate, discuss plans for ensuring necessary medical or professional intervention
in the event of adverse effects on participants.
l Describe plans for handling incidental findings, such as those from research imaging,
screening tests, or paternity tests.
c. Vulnerable Subjects, if relevant to your study
Explain the rationale for the involvement of special vulnerable populations, such as fetuses, neonates,
pregnant women, children, prisoners, institutionalized individuals, or others who may be considered
vulnerable populations. 'Prisoners' includes all subjects involuntarily incarcerated (for example, in
detention centers).
Pregnant Women, Fetuses, and Neonates or Children
If the study involves vulnerable subjects subject to additional protections under Subparts B and D
(pregnant women, fetuses, and neonates or children), provide a clear description of the risk level and
additional protections necessary to meet the HHS regulatory requirements.
l HHS’ Subpart B - Additional Protections for Pregnant Women, Fetuses, and Neonates
l HHS’ Subpart D - Additional Protections for Children
l OHRP Guidance on Subpart D Special Protections for Children as Research Subjects and the
HHS 407 Review Process
Prisoners
If the study involves vulnerable subjects subject to additional protections under Subpart C (prisoners),
describe how proposed research meets the additional regulatory requirements, protections, and
plans to obtain OHRP certification for the involvement of prisoners in research.
Refer to HHS regulations, and OHRP guidance:
l HHS’ Subpart C - Additional Protections Pertaining to Prisoners as Subjects
l OHRP Subpart C Guidance on Involvement of Prisoners in Research
3. Potential Benefits of the Proposed Research to Research Participants and Others
l Discuss the potential benefits of the research to research participants and others.
l Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to
research participants and others.
l Note: Financial compensation of subjects should not be presented as a benefit of
participation in research.
4. Importance of the Knowledge to be Gained
l Discuss the importance of the knowledge to be gained as a result of the proposed research.
l Discuss why the risks to subjects are reasonable in relation to the importance of the
knowledge that reasonably may be expected to result.
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For more information:
l Refer to the NIH’s Human Subjects Research website.
3.2 Is this a multi-site study that will use the same protocol to conduct non-
exempt human subjects research at more than one domestic site?
Select "Yes" or "No" to indicate whether this is a multi-site study that will use the same
protocol to conduct non-exempt human subjects research at more than one domestic site.
Select “N/A” only if any of the following apply (do not select “N/A” if none of the following apply):
l You answered “Yes” to “Question 1.2 Is this Study Exempt from Federal Regulations?
(Yes/No)”
l You are a training grant applicant.
Applicants who check “Yes” are expected to use a single Institutional Review Board (sIRB) to
conduct the ethical review required by HHS regulations for the Protections of Human Subjects
Research unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation,
or policy.
Note: The NIH sIRB policy applies to participating domestic sites. Foreign sites
participating in NIH-funded, multi-site studies are not expected to follow this
policy.
For more information:
l HHS regulations and requirements for the Protections of Human Subjects can be found
at 45 CFR 46.
l See NIH’s Single IRB Policy for Multi-site Research for more information.
l See the FAQ about answering “No” for this question on the Applying Electronically FAQ
page.
If yes, describe the single IRB plan
For NIHApplicants, the single IRBplan is no longer required. See additional information in
the content section below.
For AHRQ applicants, if this is a research project that involves more than one institution and
that will be conducted in the United States, Applicants are expected to use a single Institutional
Review Board (sIRB) to conduct the ethical review required by HHS regulations for the
Protections of Human Subjects Research, and include a single IRB plan as instructed below,
unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.
Note: The sIRB requirement applies to participating sites in the United States. Foreign sites
participating in AHRQ-funded, cooperative research studies are not expected to follow this
requirement.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
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Although one sIRB attachment per application is sufficient, you must include a file for each study
within your application. All filenames within your application must be unique. You may either
attach the same sIRB plan (with different filenames) to different studies or attach a file that refers
to the sIRB plan in another study within your application. For example, you may attach a file that
says “See sIRB plan in the 'My Unique Study Name' study.”
Content:
For NIHapplicants, the single IRB plan is no longer required. Do not provide an attachment.
The applicant must provide a statement naming the sIRB of record in the Just-in-Time
submission prior to award.
For Studies with Legal-, Regulatory-, or Policy-based Claims for Exception as described by
the sIRB Policy: As part of the Just-in-Time submission prior to award, indicate that review by an
sIRB will not be possible for all or some sites (specify which sites) because local IRB review is
required by an existing federal/state/tribal law or policy. Include a specific citation to the relevant
law, policy, or regulation.
For sites requesting an exception based on compelling justification: Indicate which site(s) is
requesting an exception to the use of the sIRB and provide compelling justification based on
ethical or human subjects protection issues or other well-justified reasons. NIH will determine
whether to grant an exception following an assessment of the need. Note: If you intend to
request an exception to the sIRB policy based on compelling justification, do not account for this
exception in your proposed budget. The proposed budget must reflect any necessary sIRB costs
without an exception (i.e., applicants should not assume that an exception will be granted when
considering what sIRB costs to include in the budget).
For more information:
l NIH's Single IRB Policy for Multi-site Research page
l NIH's FAQs on Single IRB Policy for Multi-site Research
l NIH's Office of Science Policy's FAQs on NIH Policy on the Use of a Single IRB for Multi-
Site Research Costs
l NIH's Office of Science Policy's FAQs on Implementation of the sIRB policy
l NIH Guide Notice on the Revised NIHPolicy on SIRB.
For AHRQ applicants, the single IRB plan should include the following elements:
l Describe how you will comply with the single IRB review requirement under the Revised
Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the
IRB that you anticipate will serve as the sIRB of record.
l Indicate that all identified participating sites will agree to rely on the proposed sIRB and that
any sites added after award will rely on the sIRB.
l Briefly describe how communication between sites and the sIRB will be handled.
l Indicate that all participating sites will, prior to initiating the study, sign an
authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and
participating sites.
l Indicate which institution or entity will maintain records of the authorization/reliance
agreements and of the communication plan.
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l Note: Do not include the authorization/reliance agreement(s) or the communication plan(s)
documents in your application.
l Note: If you anticipate research involving human subjects but cannot describe the study at
the time of application, include information regarding how the study will comply with the
single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in
the delayed onset study justification.
For Studies with Legal-, Regulatory-, or Policy-based Claims for Exception as described by
the sIRB Policy: Indicate that review by a sIRB will not be possible for all or some sites (specify
which sites) because local IRB review is required by an existing federal/state/tribal law or policy.
Include a specific citation to the relevant law, policy, or regulation.
For more information:
• AHRQ Guide Notice on Single IRB
• AHRQ Protection of Human Subjects page
3.3 Data and Safety Monitoring Plan
A “Data and Safety Monitoring Plan” attachment is required if you answered “Yes” to all the
questions in the “Clinical Trial Questionnaire.” The “Data and Safety Monitoring Plan” attachment
is optional for all other human subjects research.
For human subjects research that does not involve a clinical trial: Your study, although it is
not a clinical trial, may have significant risks to participants, and it may be appropriate to include
a data and safety monitoring plan. If you choose to include a data and safety monitoring plan,
you may follow the content criteria listed below, as appropriate.
For AHRQ Applicants, Data and Safety Monitoring (DSM) plans are required in all non-exempt
research applications when support is sought to study the effect of a health-related intervention
on outcomes in human subjects where there is greater than minimal risk.
If you seek AHRQ support to conduct non-exempt research to study the effect of a health-
related intervention on outcomes in human subjects where there is greater than minimal risk, a
“Data and Safety Monitoring Plan” attachment is required.
Refer to AHRQ Data and Safety Monitoring Policy
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Include only the following information in your data and safety
monitoring plan (i.e., do not follow the standard instructions for the data and
safety monitoring plan):
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l The names of the individual(s) or group that will be responsible for trial
monitoring (i.e., the lead investigator of the clinical trial)
l If applicable, the name of an independent safety monitor or a data and
safety monitoring board
For any proposed clinical trial, NIH requires a data and safety monitoring plan (DSMP) that is
commensurate with the risks of the trial, its size, and its complexity. Provide a description of the
DSMP, including:
l Indicate how many people and what type of entity will provide the monitoring. Include
such details as whether a single person, multiple people, or a data safety monitoring
board will provide monitoring. Also indicate what type of entity will provide the
monitoring (e.g., PD/PI, Independent Safety Monitor/Designated Medical Monitor,
Independent Monitoring Committee, Safety Monitoring Committee, Data and Safety
Monitoring Board, etc.).
l The overall framework for safety monitoring and what information will be monitored.
l The frequency of monitoring, including any plans for interim analysis and stopping rules
(if applicable).
l The process by which Adverse Events (AEs), including Serious Adverse Events (SAEs) such
as deaths, hospitalizations, and life threatening events and Unanticipated Problems
(UPs), will be managed and reported, as required, to the IRB, the person or group
responsible for monitoring, the awarding IC, the NIH Office of Biotechnology Activities,
and the Food and Drug Administration.
l The individual(s) or group that will be responsible for trial monitoring and advising the
appointing entity. Because the DSMP will depend on potential risks, complexity, and the
nature of the trial, a number of options for monitoring are possible. These include, but
are not limited to, monitoring by a:
o
PD/PI: While the PD/PI must ensure that the trial is conducted according to the
approved protocol, in some cases (e.g., low risk trials, not blinded), it may be
acceptable for the PD/PI to also be responsible for carrying out the DSMP.
o
Independent safety monitor/designated medical monitor: a physician or other expert
who is independent of the study.
o
Independent Monitoring Committee or Safety Monitoring Committee: a small group
of independent experts.
o
Data and Safety Monitoring Board (DSMB): a formal independent board of experts
including investigators and biostatisticians. NIH requires the establishment of DSMBs
for multi-site clinical trials involving interventions that entail potential risk to the
participants, and generally, for all Phase III clinical trials, although Phase I and Phase II
clinical trials may also need DSMBs. If a DSMB is used, please describe the general
composition of the Board without naming specific individuals.
For more information:
l NIH Grants Policy Statement, Section 4.1.15.6: Data and Safety Monitoring
l NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials
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3.4 Will a Data and Safety Monitoring Board be appointed for this study?
The “Data Safety and Monitoring Board” question is required if you answered “Yes” to all the
questions in the “Clinical Trial Questionnaire.” This question is optional for all other human
subjects research.
Check the appropriate box to indicate whether a Data Safety and Monitoring Board (DSMB) will
be appointed for this study.
3.5 Overall Structure of the Study Team
The “Overall Structure of the Study Team” attachment is optional. Refer to your specific FOA for
specific instructions on the "Overall Structure of the Study Team" attachment.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Provide a brief overview of the organizational/administrative structure and function of the study
team, particularly the administrative sites, data coordinating sites, enrollment/participating sites,
and any separate laboratory or testing centers. The attachment may include information on
study team composition and key roles (e.g., medical monitor, data coordinating center), the
governance of the study, and a description of how study decisions and progress are
communicated and reported.
Note: Do not include study team members’ individual professional experiences (i.e., biosketch
information).
Section 4 – Protocol Synopsis
Who must complete “Section 4 – Protocol Synopsis:"
If you answered "Yes" to all the questions in the "Clinical Trial Questionnaire:" All the questions
in the “Protocol Synopsis” section are required.
If you answered “No” to any question in the “Clinical Trial Questionnaire:” Do not provide
information in this section. Inputting information in this section will result in errors and will prevent
your application from being accepted.
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not provide information in “Section 4 - Protocol Synopsis.”
Inputting information in this section will result in errors and will prevent your
application from being accepted.
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4.1. Study Design
4.1.a. Detailed Description
Enter a narrative description of the protocol. Studies differ considerably in the methods used to
assign participants and deliver interventions. Describe your plans for assignment of participants
and delivery of interventions. You will also need to show that your methods for sample size and
data analysis are appropriate given those plans. For trials that randomize groups or deliver
interventions to groups, special methods are required; additional information is available at the
Research Methods Resources webpage. The Narrative Study Description is not meant to be a
repeat of the Research Strategy.
The narrative description is limited to 32,000 characters (but typically needs only 5,000
characters), should be written in layperson’s terms, and may repeat some of the information in
the Research Strategy.
Note: This field matches a ClinicalTrials.gov field (Detailed Description).
For more information about formatting text entry fields, see NIH's Rules for Text Fields page.
4.1.b. Primary Purpose
Enter or select from the dropdown menu a single "Primary Purpose" that best describes the
clinical trial. Choose from the following options:
l Treatment
l Prevention
l Diagnostics
l Supportive Care
l Screening
l Health Services Research
l Basic Science
l Device Feasibility
l Other (If you select “Other,” provide a description in the space provided. Your response
is limited to 255 characters.)
Note: This field matches a ClinicalTrials.gov field (Primary Purpose).
4.1.c. Interventions
Complete the “Interventions” fields for each intervention to be used in your proposed protocol. If
an arm of the study to which subjects will be assigned (as discussed in 4.1.a. Detailed Description)
includes more than one intervention (e.g., drug plus educational intervention), complete this
section for each intervention. You can add up to 20 interventions.
Intervention Type: Enter or select from the dropdown menu the intervention type the clinical
trial will administer during the proposed award. Choose from the following options:
l Drug (including placebo)
l Device (including sham)
l Biological/Vaccine
l Procedure/Surgery
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l Radiation
l Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
l Genetic (including gene transfer, stem cell, and recombinant DNA)
l Dietary Supplement (e.g., vitamins, minerals)
l Combination Product
l Diagnostic Test
l Other
Name: Enter the name of the intervention. The name is limited to 200 characters.
Description: Enter a description of the intervention. The description is limited to 1,000
characters.
Note: This field matches a ClinicalTrials.gov field. (Interventions, including Intervention Type and
Intervention Name(s)).
For more information on how to answer this question for behavioral research trials, refer to the
relevant FAQ on the Applying Electronically FAQ page.
4.1.d. Study Phase
Enter or select from the dropdown menu a "Study Phase" that best describes the clinical trial. If
your study involves a device or behavioral intervention, choose “N/A”.
Choose from the following options:
l Early Phase 1 (or Phase 0)
l Phase 1
l Phase 1/2
l Phase 2
l Phase 2/3
l Phase 3
l Phase 4
l N/A
Is this an NIH-defined Phase III clinical trial? Yes/No
Select "Yes" or "No" to indicate whether the study includes an NIH-defined Phase III clinical trial.
Device and behavioral intervention studies may select “Yes” here even if the answer above is
“Other”.
For more information on how to answer this question for devices or behavioral interventions,
refer to the relevant FAQ on the Applying Electronically FAQ page.
4.1.e. Intervention Model
Enter or select from the dropdown menu a single "Intervention Model" that best describes the
clinical trial. If you select “Other,” provide a description in the space provided. Choose from the
following options:
l Single Group
l Parallel
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l Cross-Over
l Factorial
l Sequential
l Other (If you select “Other,” provide a description in the space provided. Your response
is limited to 255 characters.)
Note: This field matches a ClinicalTrials.gov field (Interventional Study Model).
For more information: Definitions of intervention models may be found in ClinicalTrials.gov’s
Glossary of Common Site Terms or in the ClinicalTrials.gov’s description of Study Design.
4.1.f. Masking
Select "Yes" or "No" to indicate whether the protocol uses masking. Note that masking is also
referred to as “blinding.”
If you answered “Yes” to the “Masking” question, select one or more types of masking that best
describes the protocol. Choose from the following options:
l Participant
l Care Provider
l Investigator
l Outcomes Assessor
Note: This field matches a ClinicalTrials.gov field (Masking).
4.1.g. Allocation
Enter or select from the dropdown menu a single "Allocation" that best describes how subjects
will be assigned in your protocol. If allocation is not applicable to your clinical trial, select “N/A”
(e.g., for a single-arm trial). Choose from the following options:
l N/A
l Randomized
l Non-randomized
Note: This field matches a ClinicalTrials.gov field (Allocation).
4.2. Outcome Measures
Complete the “Outcome Measures” fields for each primary, secondary, and other important
measures to be collected during your proposed clinical trial. You may have more than one
primary outcome measure, and you can add up to 50 outcome measures.
Name: Enter the name of the individual outcome measure. The outcome measure must be
unique within each Study Record.
Type: Enter or select from the dropdown menu the type of the outcome measure. Choose from
the following options:
l Primary – select this option for the outcome measures specified in your protocol that are
of greatest importance to your study
l Secondary – select this option for outcome measures specified in your protocol that are
of lesser importance to your study than your primary outcomes
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l Other – select this option for additional key outcome measures used to evaluate the
intervention.
Time Frame: Indicate when a measure will be collected for analysis (e.g., baseline, post-
treatment).
Brief Description: Describe the metric used to characterize the outcome measure if the metric is
not already included in the outcome measure name. Your description is limited to 999 characters.
NIH-Defined Phase III Clinical Trials: If the proposed research includes an NIH-Defined Phase
III Clinical Trial, then outcomes for required analyses by sex/gender, race, and ethnicity should be
entered.
Additional information about valid analysis is available on the NIH Policy and Guidelines on The
Inclusion of Women and Minorities as Subjects in Clinical Research page.
Note: This field matches a ClinicalTrials.gov field (e.g., Primary Outcome Measure Information,
which includes Title, Description, and Time Frame).
For more information:
l Refer to the relevant FAQ for question 4.2 Outcome Measures on the Applying
Electronically FAQ page.
4.3. Statistical Design and Power
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Specify the number of subjects you expect to enroll, the expected effect size, the power, and the
statistical methods you will use with respect to each outcome measure you listed in 4.2 Outcome
Measures.
You will need to show that your methods for sample size and data analysis are appropriate given
your plans for assignment of participants and delivery of interventions. For trials that randomize
groups or deliver interventions to groups, special methods are required; additional information is
available at the Research Methods Resources webpage.
4.4 Subject Participation Duration
Enter the time (e.g., in months) it will take for each individual participant to complete all study
visits. If the participation duration is unknown or not applicable, write “unknown” or “not
applicable.” The subject participation duration is limited to 255 characters.
4.5 Will the study use an FDA-regulated intervention?
Select "Yes" or "No" to indicate whether the study will use an FDA-regulated intervention (see the
definition of “FDA Regulated Intervention” under the Oversight section of the ClinicalTrials.gov
Protocol Registration Data Element Definitions for Interventional and Observational Studies
page).
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4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New
Drug (IND)/Investigational Device Exemption (IDE) status:
This attachment is required if you answered “Yes” to the “Will the study use an FDA-regulated
intervention?” question.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
This attachment’s typical length is approximately 3,000 characters.
Content:
Provide a summary describing the availability of study agents and support for the acquisition and
administration of the study agent(s).
Please indicate, if applicable, the IND/IDE status of the study agent, including whether a clinical
investigation is exempt from the IND/IDE requirement. Also indicate whether the investigators
have had any interactions with the FDA (e.g., indicate if the FDA has stated that research may
proceed). If the study agent currently has an IND/IDE number, provide that information.
Do not include the IND/IDE application, manufacturer’s product specifications, study protocol, or
protocol amendments in this attachment.
Additional information such as FDA letters or correspondence with the FDA may be requested in
the FOA.
Note: The awarding component may request consultation with the FDA and the IND/IDE
sponsor about the proposed clinical trial after peer review and prior to award.
4.6 Is this an applicable clinical trial under FDAAA?
Select "Yes" or "No" to indicate whether the study is an applicable clinical trial (ACT) under the
Food and Drug Administration Amendments Act (FDAAA).
For more information:
l NIH Glossary’s definition of an applicable clinical trial
l FAQs on the ClinicalTrials.gov & FDAAA
4.7 Dissemination Plan
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Although one Dissemination Plan per application is sufficient, you must include a file for each
study within your application. All filenames within your application must be unique. You may
either attach the same Dissemination Plan to different studies or attach a file that refers to the
Dissemination Plan in another study within your application. For example, you may attach a file
that says “See Dissemination Plan in the 'My Unique Study Name' study.”
Content:
Explain briefly your plan for the dissemination of NIH-funded clinical trial information and
address how the expectations of the policy will be met. The plan must contain sufficient
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information to assure the following:
l the applicant will ensure that clinical trial(s) under the award are registered and results
information is submitted to ClinicalTrials.gov as outlined in the policy and according to
the specific timelines stated in the policy;
l informed consent documents for the clinical trial(s) will include a specific statement
relating to posting of clinical trial information at ClinicalTrials.gov; and
l the recipient institution has an internal policy in place to ensure that clinical trials
registration and results reporting occur in compliance with policy requirements.
Note: Do not include informed consent documents in the Dissemination Plan attachment.
Note: If your human subjects study meets the definition of “Delayed Onset,” include the
Dissemination Plan attachment in the delayed onset study justification.
For more information:
l See the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
l See the NIH Guide Notice on the Delayed Enforcement and Short-Term Flexibilities for
Some Requirements Affecting Prospective Basic Science Studies Involving Human
Participants
l See the NIH Grants Policy Statement, Section 4.1.3.1 NIH Policy on Dissemination of NIH-
Funded Clinical Trial Information.
Section 5 – Other Clinical Trial-related Attachments
Who must complete “Section 5 – Other Clinical Trial-related Attachments:"
If you answered “Yes” to all the questions in the “Clinical Trial Questionnaire:” Include an
attachment only if your FOA specifies that an attachment(s) is required or permitted; otherwise, do
not include any Other Clinical Trial-related attachments.
If you answered “No” to any question in the “Clinical Trial Questionnaire:” Do not provide
information in this section. Inputting information in this section will result in errors and will prevent
your application from being accepted.
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not provide information in “Section 5 – Other Clinical Trial-related
Attachments.” Inputting information in this section will result in errors and will
prevent your application from being accepted.
5.1 Other Clinical Trial-related Attachments
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
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A maximum of 10 PDF attachments is allowed in the “Other Clinical Trial-related Attachments”
section.
Content:
Provide additional trial-related information only if your FOA specifically requests it. Include only
attachments requested in the FOA, and use requested filenames. If a specific filename is not
given in the FOA, use a meaningful filename since it will become a bookmark in the assembled
application image.
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The PHS Assignment Request Form may be used to
communicate specific application assignment and
review preferences to the Division of Receipt and
Referral (DRR) and to Scientific Review Officers (SROs).
This information will not be part of your assembled
application, and it will neither be made available to
program staff nor provided to reviewers. It is used
specifically to convey additional, optional information
about your preference(s) for assignment and review of
your application to DRR and SROs.
View larger image
Completing the PHS Assignment Request Form:
This form is optional. Use it only if you wish to communicate
specific awarding component assignments or review preferences. There is no requirement that all
fields or all sections be completed. You have the flexibility to make a single entry or to provide
extensive information using this form.
Note on Application Assignments: The Division of Receipt and Referral (DRR), Center for Scientific
Review (CSR) is responsible for assigning applications to awarding components such as NIH
Institutes/Centers (ICs) and other PHS agencies for funding consideration. DRR also assigns
applications to NIH Scientific Review Groups (SRGs) and Special Emphasis Panels (SEPs).
Awarding Component Assignment Suggestions (optional)
To facilitate accurate communication of any assignment preferences to NIH referral and review
staff, use the short abbreviation (e.g., NCI for the National Cancer Institute).
All assignment suggestions will be considered; however, not all assignment suggestions can be
honored. Applications are assigned based on relevance of your application to an individual
awarding component mission and scientific interests in addition to administrative requirements
such as IC participation in the funding opportunity announcement used to submit your
application.
Descriptions of the scientific areas covered by all NIH ICs and links to other PHS agency
information can be found on the PHS Assignment Information website.
You do not need to make entries in all three boxes of the “Awarding Component Assignment
Suggestions” section.
Suggested Awarding Component(s):
You may enter up to three preferences for primary assignment in the boxes in the “Suggested
Awarding Component(s)” row. Note: Your application will be assigned based on the most
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appropriate match between it, the terms of the FOA, and the mission of each possible awarding
component, with your preference(s) taken into consideration when possible.
Study Section Assignment Suggestions (optional)
To facilitate accurate communication of any review assignment preferences to NIH referral and
review staff, use the short abbreviation of the SRG/SEP you would prefer. For example, enter
“CAMP” for the NIH Cancer Molecular Pathobiology study section or enter “ZRG1HDMR” for the
NIH Healthcare Delivery and Methodologies SBIR/STTR panel for informatics. Be careful to
remove all hyphens, parentheses, and spaces when you type in the suggestion. Freeform text
(such as "special emphasis panel" or "member conflict SEP") should not be entered.
All suggestions will be considered; however, not all assignment suggestions can be honored.
More information about how to identify CSR and NIH SRGs and SEPs, including their short
abbreviations, can be found on CSR Study Sections and Special Emphasis Panel. A list of all NIH
SRGs and SEPs is also available.
While the majority of NIH research grant and fellowship applications are reviewed by CSR, some
are assigned to individual IC review groups and some are clustered for review in SRGs/SEPs,
depending on existing locus of review agreements within NIH and other PHS agencies. This limits
flexibility for honoring assignment preferences.
You do not need to make an entry in all three boxes of the "Study Section Assignment
Suggestions" section.
Suggested Study Sections:
You may enter up to three preferences for SRGs/SEPs in the boxes in the “Suggested Study
Sections” row. Use one box per individual SRG/SEP preference suggestion. All review preferences
will be considered. Note: Your application will be assigned based on the most appropriate match
between it, the terms of the FOA, and the guidelines for each SRG/SEP, with your preference(s)
taken into consideration when possible.
Note: This information is not applicable if you are submitting an application to an RFA.
Rationale for assignment suggestions (optional)
Enter the rationale (i.e., why you think the assignment is appropriate) for your Awarding
Component and Study Section suggestions.
Your answer can have a maximum of 1000 characters.
List individuals who should not review your application and why (optional)
You may list specific individuals, if any, who should not review your application and why they
should not review your application. Provide sufficient information (e.g., name, organizational
affiliation) so that the SRO can correctly identify the individual. Be prepared to provide additional
information to the SRO if needed. Simply stating “Dr. John Smith is in conflict with my application”
is not helpful.
Your answer can have a maximum of 1000 characters.
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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K.600 - PHS Assignment Request Form
Identify scientific areas of expertise needed to review your application (optional)
You may list up to five general or specific types of expertise needed for the review of your
application. Limit your answers to areas of expertise – do not enter names of individuals you
would like to review your application.
Each field can have a maximum of 40 characters.
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
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Form Screenshots
K.- i
Form Screenshots
Quick Links
SF 424 (R&R) Form
PHS 398 Cover Page Supplement Form
R&R Other Project Information Form
Project/Performance Site Location(s) Form
R&R Senior/Key Person Profile (Expanded) Form
R&R Budget Form
R&R Subaward Budget Attachment(s) Form
PHS 398 Career Development Award Supplemental Form
PHS Human Subjects and Clinical Trials Information
PHS Assignment Request Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- ii
SF 424 (R&R)Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- iii
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- iv
PHS 398 Cover Page Supplement Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- v
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- vi
R&R Other Project Information Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- vii
Project/Performance Site Location(s) Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- viii
R&R Senior/Key Person Profile (Expanded) Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- ix
R&R Budget Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- x
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xi
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xii
R&R Subaward Budget Attachment(s) Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xiii
PHS 398 Career Development Award Supplemental Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xiv
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xv
PHS Human Subjects and Clinical Trials Information
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xvi
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xvii
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xviii
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xix
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xx
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
Form Screenshots
K.- xxi
PHS Assignment Request Form
Career Development Instructions for NIH and Other PHS Agencies - Forms Version F Series
