New Human Subjects and Clinical Trial Information Form

Learn about the new Human Subjects and Clinical Trial Information form which will be made available for all contract proposals for Requests for Proposals issued as of January 25, 2018 and in grant application packages for all human subjects and/or clinical trial research applications for due dates on and after January 25, 2018.

Purpose

A primary component of NIH’s initiative to enhance the stewardship of clinical trials is the creation of a new application form that consolidates all Human Subjects and Clinical Trial related information into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. This new form will be included in the new FORMS-E Application Packages to be used for all due dates on or after January 25, 2018 and should be used for all human subject contract proposals responding to Requests for Proposals issued as of January 25, 2018. 

Key Dates

  • September 25, 2017 – New FORMS-E Application Instructions available on the How to Apply - Application Guide website
     
  • October 25, 2017 - FORMS-E Application Packages will start being published for FOAs with due dates on or after January 25, 2018.
    • Note that all new application packages will be published at least 60 days ahead of the first due dates
  • January 25, 2018 – First due dates for new FORMS-E Application Packages. Responses to Requests for proposals issued as of this date must use the PHS Human Subject and Clinical Trial Information form for all proposals involving human subjects. 

During the transition period from FORMS-D to FORMS-E, both form packages will be available for some FOAs. It is important that applicants pay close attention and choose the announcement specific for their due date.

Form Changes

The most significant change with the new FORMS-E Application Package is the addition of a new PHS Human Subjects and Clinical Trials Information form. This form consolidates human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms. The form collects information on human subjects and clinical trials at the study level.

  • Leads applicants through the human subject and clinical trial information collection requirements
  • Expands the use of discrete form fields to capture clinical trial information to provide the level of detail needed for peer review
  • Presents key information to reviewers and agency staff in a consistent format
  • Aligns with ClinicalTrials.gov (where possible) and positions the NIH for future data exchange with ClinicalTrials.gov
     
Use FORMS-D for... Use FORMS-E for...

Applications submitted for due dates on or before January 24, 2018

Applications submitted under NIH Late Policy 2-week window of consideration for intended due dates on or before January 24, 2018

Applications submitted by February 7, 2018 under NIH Continuous Submission Policy for January 7, 2018 AIDS intended due date

Applications submitted for due dates on or after January 25, 2018

All application types (New, Resubmission, Renewal, Revision)

Applications submitted early for intended due dates on or after January 25, 2018

 

Resources

  1. Application Form Instructions for Forms E (see section G. 500 for PHS Human Subjects and Clinical Trial Information Form). HTML / PDF
     
  2. Take a video tour of the new form. Link to Non-U.S. Government Site - Click for Disclaimer

Thumbnail of video frame
 

  1. Annotated Form Set for NIH Grant Applications - FORMS-E Series
     
  2. High Level Summary of Form Changes: FORMS-E to learn about other form changes.  


Notices

  • NOT-OD-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions
  • NOT-OD-17-119 New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018
  • NOT-OD-18-128 Grant Application Instruction Correction for Training Grants with Human Subjects Involvement