Summary excerpt from Statement of Leonard H. Glantz, J.D: Thank you for the opportunity to speak with you today. I would like to make clear that I am speaking as an individual and that my presentation does not represent the views of Boston University School of Public Health or Public Responsibility in Medicine and Research. I am pleased to be here to mention a few of the issues that this committee may wish to address in its report. Both the FDA and the NIH have instituted polices that will increase the number of child-subjects in research projects but the federal government has not undertaken a review of the 20 year old policies that were promulgated to protect children as research subjects. This is, therefore, a very good moment in time for the Institute of Medicine to examine the ethical, social and legal issues that research with children present, and to suggest ways to improve protecting the rights and welfare of child-subjects.