U.S. Department of Health and Human Services
Public Health Service
PHS 398 (Revised 03/2020)
All notable changes made to PHS 398 instructions and form pages are listed at the bottom of this page (updated 03/25/2020).
Downloadable Instructions and Form Files
PHS 398 Instructions - 3/2020 Revision PDF (454 KB)
PHS 398 Fillable Forms - 3/2020 Revision
The links below allow for the downloading of individual and combined form files in MS Word and PDF formats. Some of the files are large and may take a few minutes to download. Please see the "Help Downloading Files" section of the Digital Standards page for information on using the fillable PDF forms.
|Fillable Individual PHS 398 Forms
(These forms are to be used only with paper submissions using the PHS 398. Do not use the PDF samples provided below in an SF424 (R&R) application. These are fillable PDF forms which will cause an error in the electronic submission of an SF424 (R&R) application. See the How to Apply - Application Guide for appropriate formats to be used for electronic submission.
|Form Page 1: Face Page||MS Word||PDF (414 KB)|
|Form Page 1-continued: Additional form for use only if Multiple PD/PIs are proposed. Do not include if submitting a single-PD/PI application.||MS Word||PDF (434 KB)|
|Form Page 2: Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells||MS Word||PDF (565 KB)|
|Project/Performance Site Format Page - use only if additional space is needed.||MS Word||PDF (282 KB)|
|Form Page 3: Research Grant Table of Contents||MS Word||PDF (273 KB)|
|Form Page 4: Detailed Budget for Initial Budget Period||MS Word||PDF (2 MB)|
|Form Page 5: Budget for Entire Proposed Project Period||MS Word||PDF (342 KB)|
|Resources Format Page||MS Word||PDF (281 KB)|
|Checklist Form Page||MS Word||PDF (528 KB)|
|Continuation Format Page||MS Word||PDF (224 KB)|
|PHS Human Subjects and Clinical Trials Information||PDF (118 KB)|
|Mailing Address||MS Word||PDF (27 KB)|
|All Personnel Report Format Page||MS Word||PDF (281 KB)|
|Combined PHS 398 Forms File
Does NOT include the Biographical Sketch page, Continuation Page, or any of the Sample/Example pages (Biosketch Sample, Other Support Sample). See Individual Form file links above.
|Combined PHS 398 Form Files
|Combined PHS 398 Form Files
(PDF) (659 KB)
Other Support: see http://grants.nih.gov/grants/forms/othersupport.htm
Biosketches: see http://grants.nih.gov/grants/forms/biosketch.htm
For Questions Related to:
- Application Procedures/Forms Submission: contact GrantsInfo at email@example.com or 301-945-7573.
Note: Other software packages for completing these applications may be available from other sources; however, it is essential that the type size and format specifications are met. Otherwise application processing may be delayed, or the application may be returned to the applicant without review.
Disclaimer: Reference to these software packages neither constitutes nor should be inferred to be an endorsement or recommendation of any product, service, or enterprise by the National Institutes of Health, any other agency of the United States Government, or any employee of the United States Government. No warranties are stated or implied.
Updated the OMB expiration date to 2/28/2023.
PHS Human Subjects and Clinical Trials Information form
- Changes were made to the form’s organization in the following sections:
- Who should use the PHS Human Subjects and Clinical Trials Information form
- Using the PHS Human Subjects and Clinical Trials Information form
- Use of Human Specimens and/or Data
- Clarified and updated instructions throughout. Significant changes were made for the following fields:
- “Provide the ClinicalTrials.gov Identifier”
- “Section 2 – Study Population Characteristics” instructions now reflect updated exceptions for required questions.
- Study Timeline
- 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.
- “Data and Safety Monitoring Plan” attachment
- Updated instructions for delayed onset studies regarding use of single IRB.
- Added new “Inclusion of Individuals Across the Lifespan” attachment.
- Updated instructions for the “Inclusion of Women and Minorities” attachment to reflect separate “Inclusion of Individuals Across the Lifespan” attachment.
- Added new “Inclusion Enrollment Report Title” field.
- Removed the “Brief Summary” field.
- Changed the “Narrative Study” field to “Detailed Description.”
- 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. Included instructions specific for AHRQ applicants.
- Included instructions specific for AHRQ applicants to Section 3.3 "Data and Safety Monitoring Plan."
- Added new "Is this an applicable clinical trial under FDAAA?" field.
- Renumbered form fields.
- Updated biosketch instructions so that scholastic performance requires only scientific/professional graduate courses to be listed
- PHS Inclusion Enrollment Report: Discontinued use (data collection moved to new PHS Human Subjects and Clinical Trials Information form)
- There is a new form for consolidated human subjects, inclusion enrollment report, and clinical trial information.
- Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
- Includes the updated appendix policy that eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.