Research Involving Wards of the State: Protecting Particularly Vulnerable Children

Abstract

In 2005, allegations arose that hundreds of children in foster care and state institutions were improperly enrolled in HIV drug trials in the late 1980s and early 1990s.(1) A watchdog group claimed that, “The most vulnerable, disadvantaged children are being exploited by powerful entities and used as guinea pigs as if they were not human beings.”(2) Subsequent coverage by the news media,(3, 4) investigation by the Office for Human Research Protections,(5) and a congressional hearing(6) focused on whether the studies followed existing federal regulations for research with children who are wards of the state.(7, 8) However, the research ethics literature has said little about the underlying question of when children who are wards of the state should be enrolled in research and what safeguards are needed to protect them. Current federal regulations mandate additional safeguards, beyond those that apply to all pediatric research, for some research with wards of the state. Although these additional requirements are attentive to the concerns research with wards of the state raises, we argue that they do not go far enough. Society is obligated to ensure the harms wards of the state have already experienced due to parental mistreatment or abandonment are not compounded by further harm from inappropriate clinical research enrollment. This means wards of the state must be appropriately protected from risk and from being unfairly selected to bear burdens in clinical research. To these ends, additional safeguards and modifications to existing guidelines are needed.