Protecting the rights of pediatric research subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

This Comment argues that the parties to the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceutical Drugs (ITCH) should adopt more specific guidelines for pediatric research than those included in its Good Clinical Practice Guidelines (ICH GCP), and analyzes their attempt to do so in the Draft Guideline on Pediatric Trials. Part I of this Comment outlines the genesis of the current international guidelines for human research and how they relate to pediatric subjects. Part I also explains the human research guidelines of the three principal members of the ICH. Part II describes the function of the ICH and the provisions of the ICH GCP. Part II also discusses how the ICH GCP addresses pediatric medical research issues, and the provisions of the new Draft Guideline on Pediatric Trials. Part III argues that the Draft Guideline on Pediatric Trials represents a significant improvement in pediatric research guidelines, and should be accepted by the parties to the ICH with some modifications regarding the subject’s consent and the role and composition of international review boards. PROTECTING THE RIGHTS OF PEDIATRIC RESEARCH SUBJECTS IN THE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE