Notice Number: NOT-OD-17-119

Key Dates
Release Date: September 25, 2017

Issued by
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)

Purpose

This Notice informs the biomedical and health services research communities that we have updated our application guide for use with grant application due dates on or after January 25, 2018 (see NOT-OD-17-062).

Focus of changes:

• New PHS Human Subjects & Clinical Trials Information Form
  • Consolidates human subjects, inclusion enrollment, and clinical trial information into one form.
  • Collects information at the study-level.
  • Uses discrete form fields to capture clinical trial information and provide the level of detail needed for peer review.
  • Presents key information to reviewers and staff in a consistent format.
  • Aligns with ClinicalTrials.gov (where possible) for future data exchange with ClinicalTrials.gov.
  • Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (see NIH-OD-17-076).
• Clarification that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form.
• Incorporation of updated appendix policy (see NOT-OD-17-098).
• Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms.
• Discontinue use of supplemental instructions for all competing applications and progress reports
• All information has been folded into the application guide form instructions and/or is contained in the appropriate policy website (e.g., NIH Grants Policy Statement).

All updates to form instructions are listed at: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.120-significant-changes.htm.

These instructions will be used in conjunction with application form packages identified with a Competition ID of "FORMS-E .

Resources:

• High-level Summary of Form Changes in FORMS-E Application Packages
• Annotated Form Set for NIH Grant Applications
• Do I Have the Right Form Version For My Application?
• Application Forms, Form Updates, and Choosing the Correct Forms FAQs
• New Human Subjects and Clinical Trial Information Form

Inquiries

Please direct all inquiries to:

NIH Grants Information
Email: grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-945-7573