The research will explore the ethical and policy issues raised by the participation of children in medical research. The goals of this project are: 1) to show that the current safeguards are inadequate and that there are systemic breeches of research ethics standards; and 2) to motivate policy makers, health care analysts, and the leaders of medicine to change practice and policy regarding the participation of children in research Specifically, the broad objectives of the project are: 1) to examine the ethical issues raised by the participation of children in research, and the need to balance access and protection; 2) to assess the ethical and policy implications of the new national policies and commissioned reports regarding the participation of children in research; 3) to identify recent published pediatric research that supports the thesis that current policies and practices are inadequate protection of children-subjects; and 4) to make policy recommendations to re-equilibrate the balance between protection and access. The main outcome of the research will be a book that offers a sustained ethical and policy critique of current policies, guidelines, and statements. The book will be entitled: Children in Medical Research: An Ethical and Policy Challenge. The book is divided into five sections. Part I addresses the problem and the current solutions and includes a historical overview of the regulations of children in research and an analytical critique of current policies, regulations and guidelines. Part H is entitled Beecher Revisited and addresses current research controversies including a chapter on placebo-controlled clinical trials, research involving healthy children and "at risk" children, genetic research, and phase I cancer research. Part Ill addresses barriers to pediatric research and includes chapters on funding, recruitment, incentives, retention of subjects, and informed consent issues. Part IV addresses research on special populations including newborns and adolescents. Part V offers revised policy recommendations.

G13LM007472

2001-09-30

2004-09-29