Main Sections

Introduction

Objectives

Part I: History and Background

Part II: Federal Policies and Regulations
1 2 3 4 5 6

Part III: Definitions

Part IV: The Review Process

End Notes and Completion Items

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Part 2: Federal Policy and Regulations

  • The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.) The main elements of the Common Rule include:
    • Requirements for assuring compliance by research institutions
    • Requirements for researchers’ obtaining and documenting informed consent
    • Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.