Summary excerpt from the Statement of American Society of Transplantation: On behalf of the American Society of Transplantation, Children's Hospital Boston and the North American Pediatric Renal Transplant Cooperative Study, I would like to thank the Members of the IOM Committee on Clinical Research Involving Children for the opportunity to provide comments and suggestions regarding children's participation in clinical research. I wish to emphasize for the committee the importance of well-designed and properly conducted clinical research involving children with serious medical disorders. Without this research, these children will not be able to benefit appropriately from the extraordinary advances of biomedical research of our age. In doing so, I will address the third and fourth questions that you have proposed. While we do agree that special safeguards must be put in place to assure that children are protected during clinical research, we caution you to assure that those safegurads are not so onerous as to prevent their participation altogether. The worst outcome for children would be that we not learn how to apply our modern medical tools and medication for their disorders.