U.S.DepartmentofHealthandHumanServices.doc

U.S. Department of Health and Human ServicesPublic Health ServiceGrant Application (PHS 398)Instructions for PHS 398 Form Approved Through 06/30/2021Rev. 06/2021 OMB No. 0925-0001TABLE OF CONTENTSPART I. INSTRUCTIONS FOR PREPARING AND SUBMITTING AN APPLICATION1. Foreword I-11.1 Application Guide Format I-21.2 NIH Extramural Research and Research Training Programs I-31.3 Research Grant Programs and Program Guidelines I-31.4 Interactions with PHS Staff I-41.5 Grants Policy Statements I-71.6 References I-71.7 Authorization I-81.7.1 Collection of Personal Demographic Data I-81.8 Paperwork Burden I-92. General Instructions I-92.1 Introduction I-92.2 Registration Processes I-102.2.1 (Reserved) I-102.2.2 DUNS Registration for the Applicant Organization & Subaward/Consortium Organizations I-102.2.3 Central Contractor Registration (CCR) for the Applicant Organization I-102.2.4 eRA Commons Registration I-112.3 (Reserved) I-122.4 Funding Opportunities I-122.4.1 NIH Guide for Grants and Contracts I-122.4.2 Funding Opportunity Announcements (FOAs) I-132.5 (Reserved) I-132.6 Format Specifications I-132.7 Resubmission Applications I-152.8 Revision Application I-172.9 Similar, Essentially Identical, or Identical Applications I-172.10 (Reserved) I-182.11 (Reserved) I-182.12 (Reserved) I-182.13 Post-Submission of Application Materials I-182.14 Application Submission Dates I-192.15 Submission, Review and Award Cycles I-202.16 Resources for Finding Help I-212.16.1 (Reserved) I-212.16.2 Finding Help for the eRA Commons Registration I-212.16.3 Finding Help for Application Preparation I-213. Submission of the Grant Application I-223.1 Cover Letter I-223.2 Number of Copies I-233.3 Bindings and Packaging I-233.4 Application Mailing Address I-244. Completing the PHS 398 Forms and Format Pages I-244.1 Face Page I-254.2 Description, Project/Performance Sites, Senior/key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells I-314.2.1 Description: Project Summary and Relevance I-314.2.2 Project/Performance Site(s) I-324.2.3 Senior/key Personnel I-324.2.4 Other Significant Contributors I-324.2.5 Human Embryonic Stem Cells I-334.3 Research Grant Table of Contents I-334.4 Budget Instructions I-334.5 Budget for Entire Proposed Period of Support I-364.6 Biographical Sketch I-364.6.1 Other Support Information I-384.7 Resources I-394.8 All Personnel Report I-395. Preparing the Research Plan, the Checklist, and the Appendix I-415.1 (Reserved) I-415.2 (Reserved) I-415.3 (Reserved) I-415.4 Research Plan Format and Notice of Proprietary Information I-415.4.1 Research Plan Format I-415.4.2 Notice of Proprietary Information I-415.5 Content of Research Plan I-425.5.1 Introduction (Resubmission or Revision Applications only) I-435.5.2 Specific Aims I-435.5.3 Research Strategy I-435.5.4 Inclusion Enrollment Report (Renewal or Revision Applications only) I-445.5.5 Bibliography and References Cited/Progress Report Publication List I-445.5.6 Protection of Human Subjects I-455.5.7 Inclusion of Women and Minorities I-455.5.8 Targeted/Planned Enrollment Table I-455.5.9 Inclusion of Children I-455.5.10 Vertebrate Animals I-455.5.11 Select Agent Research I-465.5.12 Multiple Project Director/Principal Investigator (PD/PI) Leadership Plan I-475.5.13 Consortium/Contractual Arrangements I-475.5.14 Letters of Support (e.g., Consultants) I-475.5.15 Resource Sharing Plan(s) I-485.6 Checklist I-485.7 Appendix I-496. The Peer Review Process I-50PART II. SUPPLEMENTAL INSTRUCTIONS FOR PREPARING THE PROTECTION OF HUMAN SUBJECTS SECTION OF THE RESEARCH PLAN1. Introduction II-12. Scenarios II-13. Instructions for Preparing the Section on Protection of Human Subjects II-34. Instructions Pertaining to Non-Exempt Human Subjects Research II-74.1 Protection of Human Subjects II-74.1.1 Risks to Human Subjects II-74.1.2 Adequacy of Protection Against Risks II-84.1.3 Potential Benefits of the Proposed Research to Human Subjects and Others II-94.1.4 Importance of the Knowledge to be Gained II-94.1.5 Data and Safety Monitoring Plan II-94.1.6 ClinicalTrials.gov Requirements II-104.2 Inclusion of Women and Minorities II-114.2.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed II-134.3 Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research II-134.4 Inclusion of Children II-155. Human Subjects Research Policy II-165.1 Protection of Human Subjects II-165.2 Vulnerable Populations II-175.3 Data and Safety Monitoring Plans for Clinical Trials II-175.4 IRB Approval II-185.5 Required Education in the Protection of Human Research Participants II-185.6 NIH Policy on the Inclusion of Women an。