DOUBLE PROTECTION: Reaching Accord on the Ethical Conduct of Child Observational Research

Abstract

From Bernardino Ramazzini’s visits to seventeenth-century craftsmen’s worksites—where he made observations that earned him the title of “father of occupational medicine”—to modern-day research leading to bans on public smoking, observational studies have improved and enhanced environmental health. Such studies involve observing people’s everyday lives, defining the characteristics of their environments, and determining whether any risks arise from activities within the context of those environments. Modern environmental observational studies, including the recently launched National Children’s Study, also measure environmental compounds and their metabolites in people’s bodies while assessing sources and routes of exposure so that the appropriate agencies can initiate reduction strategies if high exposures are seen. Generally, an observational study is conducted without the observer intervening with research subjects to avoid undermining research goals. However, strict adherence to this practice could create significant ethical concerns, particularly when a vulnerable subject such as a child is at risk for harm. Misunderstandings and disagreements about how those concerns should be addressed in children’s observational exposure studies have forced researchers and policy makers to more precisely—and now possibly successfully—define what constitutes a scientifically rigorous and ethical study.