1. NIH FORMS E Changes Faculty Info Session
Office of Sponsored Projects January 10, 2018

2. Show Principal Investigators the new PHS Human Subjects and Clinical Trial Information Form
Explain how new requirements will impact proposal submission
Funding Opportunity Announcement (FOA) selection
Discuss three submission scenarios:
Human Subjects = No
Human Subjects = Yes - No Clinical Trial
Human Subjects = Yes - Clinical Trial
List NIH resources available to help PIs navigate the new process
Session Goals

3. For NIH Applications Due on or after January 25, 2018
Purpose of the Changes
For NIH Applications Due on or after January 25, 2018
Current FORMS D application is being replaced by FORMS E application
New PHS Human Subjects & Clinical Trial Information Form
Consolidates Human Subject & Inclusion Report Info into one form
Expands clinical trial data collection for review and oversight
Future potential to integrate with ClinicalTrials.gov, when applicable

4. What Does This Change Mean for Principal Investigators?
If a FORMS D application is submitted for Jan 25, or later, NIH will reject the proposal without review
PIs will need to know in advance if their application is a Clinical Trial or not
PIs will need to know how to find and select the correct FOA to give to their administrators
PIs will need to provide more information for all proposals – even if an application is not a Clinical Trial
What Does This Change Mean for Principal Investigators?

5. NIH “Clinical Trial Questionnaire”
The Linchpin of the New Requirements
NIH “Clinical Trial Questionnaire”

6. Choosing the Correct FOA is Essential to Submission Success
4 Clinical Trial Questions determine correct FOA
NIH resources for Clinical Trial (CT) definition
There will be 4 types of FOAs
CT Not Allowed
CT Required
CT Optional
CT Infrastructure (e.g., NIH cooperative agreement)
FOA Titles will indicate type
FOA Section II will indicate type
All ‘Clinical Trial Required’ FOAs will be reissued
Read the entire FOA before applying
Clinical Trial-specific review criteria
Choosing the Correct FOA is Essential to Submission Success

7. FOA Clinical Trial Status Indicators

8. What if the Incorrect FOA is Used?
Technically, your application cannot be submitted
NIH Application Validations prevent incorrect FOA use
Last set of validations; occur before OSP submission
You do not want to learn this on the day your application is due!
Adhering to the OSP Proposal Deadlines will help
7-Business Day Review
2-Business Day Submission
Insure that you are using the correct FOA
Utilize NIH resources
the-right-funding-opportunity-announcement-foa/
What if the Incorrect FOA is Used?

9. The New Form Presentation Abbreviations
PHS Human Subjects & Clinical Trials Information Form
CT = Clinical Trial
HS = Human Subjects
Show Form Completion Examples:
Human Subjects = No
Human Subjects = Yes – No CT
Human Subjects = Yes – CT
The New Form Presentation Abbreviations

10. Human Subjects = No New Required Question:
Does the proposed research involve human specimens and/or data?
If Yes, Document Upload Required
If No, No Further Action Required
Human Subjects = No
Required if No

11. Human Subjects = Yes New Requirement: Must Select a Study Record:
Proposed Study
Delayed Onset Study
NIH Definition: Delayed onset generally means that a study has not been developed and cannot be described in terms of human subjects protection and inclusion
Human Subjects = Yes
Q3 or Q4 Required

12. Delayed Onset Study Record
A Study that can be described but will not start until later in the project is NOT Delayed Onset per NIH
Refer to the SF424 Instructions for question completion
Delayed Onset Study Record

14. Study Record: Section 2

15. Study Record: Section 2

16. Study Record: Section 2

17. Study Record: Section 2 – Inclusion Enrollment Report

18. Study Record: Section 3

19. Study Record: Section 4

20. Study Record: Section 4

21. Study Record: Section 4

22. Study Record:
Section 4

23. Study Record: Section 5

24. Decision Making tool https://grants. nih
FAQ
Case Studies
Video: A Walk-through of the PHS Human Subjects and Clinical Trial Information Form clinical-trial-info-form.htm
SF424 Instruction Guide
NIH Resources

25. A Note About the SF424 Application Guide
Choose FORMS E Version of SF424 Instruction Guide e/general/g.100-how-to-use-the-application-instructions.htm
Includes Instructions for Specific Mechanisms (e.g., Career Development, Fellowship)
Step-by-Step Guidelines for New Form Completion (screen shot examples on next slides)
A Note About the SF424 Application Guide

26. FORMS E - SF424 Instruction Guide

28. Summary PIs will need more time for proposal development
To read the new form guidelines
To research and choose the correct FOA
To prepare answers for the new form using the SF424 Guidelines (before routing preferably)
To work with department research administrators before routing a proposal
Summary

29. Office of Sponsored Projects (OSP) www. dartmouth. edu/~osp sponsored
Office of Sponsored Projects (OSP) (603) Committee for the Protection of Human Subjects (CPHS) (603)
Dartmouth Resources