Transcription of Supplemental Grant Application Instructions
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Supplemental Grant Application Instructions
Updated 03/2016 Supplemental Grant Application Instructions For All Competing Applications and Progress Reports Form Approved Through 10/31/2018 OMB No. 0925-0001 and OMB No. 0925-0002 ii TABLE OF CONTENTS PART II Supplemental Instructions FOR PREPARING THE PROTECTION OF HUMAN SUBJECTS SECTION OF THE RESEARCH PLAN, AND HUMAN SUBJECTS RESEARCH POLICY Table of Contents .. i 1. Introduction .. II-1 2. Scenarios .. II-1 Scenario A. No Human Subjects Research .. II-1 Scenario B. Non-Exempt Human Subjects Research .. II-1 Scenario C. Exempt Human Subjects Research .. II-2 Scenario D. Delayed-Onset Human Subjects Research .. II-2 Scenario E. Human Subjects Research Involving a Clinical Trial .. II-2 Scenario F. Human Subjects Research Involving an NIH-Defined Phase III Clinical Trial .. II-3 Scenario A. No Human Subjects Research Proposed .. II-3 Scenario B.
the Inclusion of Women and Minorities, the PHS Inclusion Enrollment Reports(s), and the Inclusion of Children. All definitions related to human subjects research are linked to text found in Part III Section 3 under Human Subjects Research Definitions and Terms. Part II Section 5 of this document includes descriptions of
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