Responsible Conduct of Research

By Adil E. Shamoo; David B. Resnik | Go to book overview

9
The Use of Human Subjects in Research

This chapter discusses the history of human experimentation, with special attention to cases that have helped to shape ethical codes and policies. It discusses important codes, such as the Nuremberg Code and the Declaration of Helsinki, and it provides an overview of U.S. federal regulations. The chapter also addresses some key concepts and principles in human research, such as informed consent, risk/benefit ratios, minimal risk, research versus therapy, and vulnerable populations.

The use of human subjects in research came into sharp focus during the Nuremberg war crimes trials, when the world discovered the atrocities committed by Nazi doctors and scientists on tens of thousands of prisoners held in concentration camps. While these tribunals were unfolding, the American Medical Association (AMA) was developing a set of principles to be followed in experiments using human subjects (Advisory Committee 1995). After the tribunals concluded, in 1947 the research community adopted the world's first international code for research on human subjects, the Nuremberg Code (quoted in Advisory Committee 1995, p. 103). The code emphasizes the importance of fully informed and voluntary consent of research subjects, minimization of harms and risks to subjects, scientific validity of research design, and the social value of the research. Since Nuremberg, there have also been many documented cases of unethical or questionable research conducted in the United States and other countries (Capron 1989; Beauchamp and Childress 1994; Advisory Council 1995). There have also been many ethical controversies in human subjects research, such as the use of placebos in research, the nature and practice of informed consent, and research on vulnerable populations, such as children, prisoners, and the mentally ill (Shamoo and Irving 1993, Egilman et al. 1998 a, b). As a result, various federal agencies and scientific and professional associations have developed regulations and codes governing human subjects research, and there has been a great deal of discussion and debate about ethical standards that should govern the use of humans in research (Levine 1988, Pence 1996). This chapter reviews these regulations after providing a historical and philosophical perspective on these issues.


HISTORICAL BACKGROUND: HUMAN EXPERIMENTATION BEFORE WORLD WAR II

Alexander Morgan Capron (1989) has observed that “the darkest moments in medical annals have involved abuses of human research subjects” (p. 127). A brief survey of the history of human subjects research supports this view. Before the Scientific Revolution (circa 1500–1700 AD), medicine was an observational rather than an experimental science. Medical research was based on the

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