Chapter 1 - Human Subjects Research Protections

Abstract

The aim of this chapter is to present an overview of the history, processes, and selected issues related to the institutional oversight of human subjects research. Our beginning point is the human research protection program (HRPP). An HRPP encompasses all aspects and components of an institution involved in conduct and oversight of human subjects research—in other words, more than just the Institutional Review Board (IRB) or Research Ethics Committee (REC) itself. This chapter begins with a historical perspective—a discussion of some of the practices and processes that gave rise to our contemporary principles of, and processes for, human subject research protections. An overview of the regulatory context follows: review of the major regulatory mandates and the regulatory agencies as well as committees empowered to oversee and implement those mandates. The chapter concludes with a discussion of common challenges, mechanisms for addressing or preventing noncompliance issues, and, finally, a discussion of some of the issues that may shape the future directions of human subjects protection.