Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent--have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations&#8212racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis&#8212are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: * expand the definition of "prisoner"; * ensure universally and consistently applied standards of protection; * shift from a category-based to a risk-benefit approach to research review; * update the ethical framework to include collaborative responsibility; and * enhance systematic oversight of research involving prisoners.