Main Sections

Introduction
1 2 3 4 5

Objectives

Part I: History and Background

Part II: Federal Policies and Regulations

Part III: Definitions

Part IV: The Review Process

End Notes and Completion Items

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Research Involving Human Subjects

  • Research has to be based on the highest standards of responsible conduct, based upon ethical principles by each and every individual taking part. Let me make it unmistakably clear, in case anyone has any doubts. If institutions and individuals fail to accept their responsibilities and in good faith work to achieve them, then they simply should not be permitted to engage in this [research] endeavor. (Dr. Greg Koski, Director, DHHS OHRP, August 2000.)
  • What’s at stake is the integrity of research, and public confidence in that research. (Donna Shalala, Secretary, Department of Health and Human Services, May 2000)