Children in medical research: balancing protection and access--has the pendulum swung too far?

This paper examines the changes in policies regarding children in research between 1966 and 2003. The changes reflect a shift in focus from protection to access. The need for protection was brought to light in 1966, with the publication of Henry Beecher's "Ethics and Clinical Research," which described 22 research projects that he considered unethical. Four of these involved child subjects. Within a few years, Paul Ramsey and Richard McCormick debated the ethical acceptability of enrolling children in any non-therapeutic research. The first U.S. policies to address the protection of human subjects were written in the 1970s and 1980s, and additional protections (Subpart D) were provided to child subjects, who were considered particularly vulnerable. In the 1990s, however, several new policies were implemented by the National Institutes of Health, the Food and Drug Administration, and Congress, in which the focus had shifted from protecting children from research risks to ensuring access. The article describes the new policies, examines the motivations for the change, and describes some of the effects of these policies. It concludes by suggesting that greater attention must be paid to ensure that increased access is not achieved by undermining the additional protections to children provided by Subpart D.