Main Sections

Introduction

Objectives

Part I: History and Background

Part II: Federal Policies and Regulations

Part III: Definitions
1 2 3
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Part IV: The Review Process

End Notes and Completion Items

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Part 3: Definitions

  • What is a human subject?

Human Subject means

a living individual about whom an investigator conducting research obtains

1) data through intervention or interaction with the individual, or

2) identifiable private information.

  • What is private information?

Private Information means

1) Information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place.

2) Information provided for specific purposes that the individual can reasonably expect will not be made public (e.g., a medical record).

  • What is research?

Research means

1) A systematic investigation designed to develop or contribute to generalized knowledge

2) It includes research, development, testing, evaluation, i.e., pilot studies.

  • What is Minimal Risk?

Minimal risk is a term that

1) is critical to the way IRBs evaluate proposed research.

2) means the risks of harm anticipated in the proposed research are not greater, considering both probability and magnitude, than those ordinarily encountered in daily life, or during routine physical examinations.