Ethics and Research with Children: A Case-Based Approach

By Eric Kodish | Go to book overview

16
Children and Placebos

Jessica Wilen Berg


CASE DESCRIPTION

Many children suffer from psychiatric illnesses, and yet few studies have been done on the available medications. In one case a research trial is proposed involving children suffering from attention deficit-hyperactivity disorder (ADHD). ADHD is not life-threatening but may result in significant learning and social disabilities. Standard therapies, such as Ritalin, are available. The trial is designed as a double-blind placebo-controlled study. Subjects in the placebo arm would be without medication for a 2-month period.

Pediatric research is a subject of controversy, as evidenced by the chapters in this book. Placebo-controlled trials are a hotly debated issue (Hoffman, 2001). The combination of the two—use of placebos in pediatric research—is certain to raise ethical concern in both the scientific and lay communities. This chapter explores the ethical aspects of using placebo controls in pediatric research trials, drawing on the study described above to demonstrate the range of issues raised. It begins with a brief discussion of placebos and outlines the arguments supporting their use in pediatric populations, starting from the assumption that placebos are ethical in some studies with competent adult subjects and in fact may be necessary in order to obtain good scientific data regarding new treatments (Leber, 2000). Analysis of the debate about placebo use in general is left to others (Miller & Brody, 2002; Rothman & Michels, 2002). After providing this brief background on placebo use in pediatric research, the chapter then identifies the current legal and ethical guidelines that apply to such use. Finally, it considers the ethical issues raised by the placebos use and explores how those issues play out when the subjects in question are children. It does not seek to provide definitive answers on the use of placebos in pediatric research trials, but rather to identify the range of ethical concerns that may help evaluation of different protocols.

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