Transition to Forms E for all NIH Grant Applications with Due Dates On or After January 25, 2018
About the New NIH Application Form
National Institutes Health has published its new application guide for applications with due dates on or after January 25, 2018.
Focus of changes:
- New PHS Human Subjects & Clinical Trials Information
- 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
- 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
- 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
- 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:
Learn More about the Forms E Application
- New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018 -
web link - published 09/25/17
- New NIH "FORMS-E" Grant Application Forms and Instructions Coming for
Due Dates On or After January 25, 2018 - web link - published
Learn More about Single IRB for Multi-Site Clinical Trials
- Overview (3:37 minutes)
- Part I: Changes for All Research Involving Human Subjects (4:52 minutes)
- Part II: Changes for Clinical Trials (6:18 minutes)
last updated 10/19/17
- Updated Appendix Policy Eliminates Clinical Trial-Related Materials
for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After
January 25, 2018 - web link -
- Revision: Notice of Extension of Effective Date for Final NIH Policy
on the Use of Single Institution Review Board for Multi-Site
Research - web link - published 06/16/17
- NOT-OD-17-043 - Update on Clinical Trial Funding Opportunity Announcement Policy - web link - published 02/17/17
- Reminder: New Appendix policy for NIH/AHRQ/NIOSH Applications
submitted for Due Dates On or After January 25, 2017 - web
link - published 01/13/17
- Scenarios to Illustrate the Use of Direct and Indirect Costs for
Single IRB Review under the NIH Policy on the Use of a Single IRB for
Multi-site Research - web link - 06/21/16
- NOT-OD-16-094 - Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research - web link - 06/21/16
- NOT-OD-15-015 - Notice of Revised NIH Definition of “Clinical Trial” - web link - 10/23/14