Transcription of Supplemental Grant Application Instructions
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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.
information provided in the Research Plan and Protection of Human Subjects section. Please note: if the proposed research involves only the use of human data or biological specimens, you should first determine whether the research involves human subjects.
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