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

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

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

What Does This Change Mean for Principal Investigators? If a FORMS D application is submitted for Jan 25, 2018 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?

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

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

FOA Clinical Trial Status Indicators

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 https://nexus.od.nih.gov/all/2017/12/07/be-careful-to-pick- the-right-funding-opportunity-announcement-foa/ What if the Incorrect FOA is Used?

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

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

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

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

Study Record: Section 2

Study Record: Section 2

Study Record: Section 2

Study Record: Section 2 – Inclusion Enrollment Report

Study Record: Section 3

Study Record: Section 4

Study Record: Section 4

Study Record: Section 4

Study Record: Section 4

Study Record: Section 5

Decision Making tool https://grants. nih FAQ https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm Case Studies https://grants.nih.gov/policy/clinical-trials/case-studies.htm Video: A Walk-through of the PHS Human Subjects and Clinical Trial Information Form https://grants.nih.gov/policy/clinical-trials/new-human-subject- clinical-trial-info-form.htm SF424 Instruction Guide https://grants.nih.gov/grants/how-to-apply-application-guide.html NIH Resources

A Note About the SF424 Application Guide Choose FORMS E Version of SF424 Instruction Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms- 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

FORMS E - SF424 Instruction Guide

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

Office of Sponsored Projects (OSP) www. dartmouth. edu/~osp sponsored Office of Sponsored Projects (OSP) www.dartmouth.edu/~osp sponsored.projects@dartmouth.edu (603) 646-3007 Committee for the Protection of Human Subjects (CPHS) www.dartmouth.edu/~cphs cphs.tasks@dartmouth.edu (603) 646-6482 Dartmouth Resources