Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations

Abstract

These guidelines are designed to provide a format allowing for the protection of child subjects in drug research. Research involving children carries with it additional responsibilities for the investigator, IRB, and sponsor. The additional responsibilities should not be reasons for the pharmaceutical company, IRB, or the investigator to exclude children from drug research and its potential benefits. It is hoped that these guidelines foster an increase in the number of drug investigations carried out in children, thereby improving their health care. The AAP believes it is unethical to deny children appropriate access to existing and new therapeutic agents. It is the combined responsibility of the pediatric community, pharmaceutical industry, and regulatory agencies to conduct the necessary studies; it is the responsibility of the general public to support the necessary research in order to assure that all children have access to important medications and receive optimal drug therapy.