May 6, 2020

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 鈥淒escription of Candidate鈥檚 Contribution to Program Goals鈥� to the Environment and Institutional Commitment聽to Candidate Section
    • Renumbered form fields, as needed
  • PHS Fellowship Supplemental Form
    • Added new attachment titled 鈥淒escription of Candidate鈥檚 Contribution to Program Goals鈥� 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 鈥淒oes any of the proposed research in the application involve human specimens and/or data?鈥� for all applications
    • Study record changes
      • Defaulted Clinical Trial Questionnaire question 鈥�1.4.a Does the study involve human participants?鈥� to Yes, since study records are only聽available when the answer to the 鈥淎re Human Subjects Involved?鈥� question on the R&R Other Project Information form is Yes
      • Separated 鈥淚nclusion of Women, Minorities, and Children鈥� attachment into two attachments 鈥� 鈥淚nclusion of Individuals Across the Lifespan鈥澛燼nd 鈥淚nclusion of Women and Minorities鈥�
      • Renamed 鈥淓nrollment of First Subject鈥� field to 鈥淓nrollment of First Participant鈥�
      • Added 鈥淚nclusion Enrollment Report Title鈥� field to the Inclusion Enrollment Report
      • Removed 鈥淏rief Summary鈥� attachment
      • Renamed 鈥淣arrative Study Description鈥� attachment to 鈥淒etailed Description鈥�
      • Added a new question and checkbox 鈥� 鈥淚s this an applicable clinical trial under FDAAA?鈥�
      • 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 鈥淩ationale for assignment suggestions鈥� text box