May 2020 SAGE Grant Runner Forms F Release
These are the Grant Runner updates for Forms F:
- The expiration date for every form has been updated to 02/28/2023
- PHS 398 Cover Page Supplement
- Added new Human Fetal Tissue Section with the question: Does the proposed project involve human fetal tissue obtained from elective abortions?
- If answered Yes, two new attachments are requested
- 1. HFT Compliance Assurance
- 2. HFT Sample IRB Consent Form
- Renumbered form fields, as needed
- PHS 398 Career Development Award Supplemental Form
- Added new attachment titled “Description of Candidate’s Contribution to Program Goals” to the Environment and Institutional Commitment to Candidate Section
- Renumbered form fields, as needed
- PHS Fellowship Supplemental Form
- Added new attachment titled “Description of Candidate’s Contribution to Program Goals” to the Institutional Environment and Commitment to Training Section
- Renumbered form fields, as needed
- PHS Human Subjects and Clinical Trials Information
- Reworked the form summary page to require an answer and supporting explanation (if applicable) for the question “Does any of the proposed research in the application involve human specimens and/or data?” for all applications
- Study record changes
- Defaulted Clinical Trial Questionnaire question “1.4.a Does the study involve human participants?” to Yes, since study records are only available when the answer to the “Are Human Subjects Involved?” question on the R&R Other Project Information form is Yes
- Separated “Inclusion of Women, Minorities, and Children” attachment into two attachments – “Inclusion of Individuals Across the Lifespan” and “Inclusion of Women and Minorities”
- Renamed “Enrollment of First Subject” field to “Enrollment of First Participant”
- Added “Inclusion Enrollment Report Title” field to the Inclusion Enrollment Report
- Removed “Brief Summary” attachment
- Renamed “Narrative Study Description” attachment to “Detailed Description”
- Added a new question and checkbox – “Is this an applicable clinical trial under FDAAA?”
- Renumbered form fields, as needed
- PHS Assignment Request form
- Clarified instruction text displayed on form
- Changed several field labels
- Removed fields
- Do Not Assign to Awarding Components
- Do Not Assign to Study Sections
- Added “Rationale for assignment suggestions” text box