In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children
considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
"...comprehensively discusses the conflicting objectives of scientific research that involves children: ensuring that children benefit from the progress in medical care made possible by such research while minimizing the risks from their participation. ... The report is both welcome and timely. ... The report does not merely stress the need to protect children from being exploited in research but correctly emphasizes the ethical importance of such pediatric research. ... The committee should be commended on its willingness to make important recommendations on difficult issues. The report contains a wealth of information and suggestions for all who are concerned with clinical research that involves children, and it should receive wide dissemination and discussion."
-- New England Journal of Medicine, August 12, 2004