Protection of child human subjects

Abstract

Historical evidence indicates that research in child issues often involved institutionalized children, which resulted in the development of federal regulations for the protection of child human subjects. The central problem in research concerning children is that children lack the legal ability to consent. Therefore, federal regulations mandate that for children over 7 parental permission and child assent are required. In the assessment of risks and benefits, investigators and reviewers should consider children's age, maturity, and psychological state. The purpose of this article is to summarize the history on research in children and the development of current federal regulations and ethical principles. Then it focuses on children's involvement in the research participation decision and assesses associated developmental risk factors.