Abstract

Research on human subjects aims to obtain knowledge of vital importance for human health and functioning. Neuroscientific research specifically is understood as oriented towards three goals: the maintenance of neurological health, the treatment of neurological diseases or syndromes, and the enhancement of neurological functioning. Most guidelines or regulations for pediatric research (whether in the U.S. or elsewhere) require that if a research intervention exposes subjects to more than minimal risk, a prospect of direct benefit is required—along with some other important criteria. It is also required for any research project, that the methods and design will yield scientifically valid knowledge. This is typically met via placebo-controlled trials. This chapter presents an argument to the effect that more than minimal risk research on pediatric subjects cannot meet both ethical requirements. The basic idea is that either the subjects in the control or experimental arm will receive a prospect of direct benefit, but not both. This chapter also argues that the ethical weight or importance of this dilemma is very acute for neuroscientific research given the complexity of the brain’s functioning and the correlated difficulty of judging whether there is a “prospect” of direct benefit. The second half responds to this argument via a case study in neuroscientific research. The solution recapitulates a type of component analysis according to which different ethical principles apply to different activities of a research study.