INTRODUCTION

The recent escalation in pediatric research, and thus the number of children exposed to research risks, raises concerns as to whether the ethical and regulatory framework for protecting children in research is adequate. What are the acceptable limits on the risks to which we should expose children for the benefit of others and society? To remain within these limits, the regulations and ethical guidelines on research involving children require careful interpretation and application. Are children truly research participants or are they merely being exploited for commercial gain? Research may be exploiting children if it does not result in publicly available knowledge regardless of the level of research risk exposure. We exploit children within research if we use them simply for the generation of profit or personal gain. The conduct of pediatric research is a privilege granted to us by the parents and children who willingly participate. The financial and professional benefits of performing this research reflect a social contract entrusting us with the future health and welfare of our children – a trust that requires transparency and full public disclosure of the research results.

This chapter (1) highlights important features of recent legislation to stimulate pediatric research; (2) reviews key elements of the U.S. pediatric research regulations, compared to guidance from the International Conference on Harmonisation (ICH), the Council for International Organizations of Medical Sciences (CIOMS), and the 2001 EU Clinical Trial Directive; (3) applies these guidelines to the choice of control group, illustrated by clinical trials of inhaled steroids in moderate asthma; and (4) briefly reviews the controversy over the use of antidepressants for major depressive disorder in adolescents.