The Bucharest Early Intervention Project: case study in the ethics of mental health research.

The Bucharest Early Intervention Project is the first ever randomized controlled trial of foster care as an alternative to institutional care for young abandoned children. This article examines ethical issues in the conceptualization and implementation of the study, which involved American investigators conducting research in another country, as well as vulnerable participants. We organize the discussion of ethical questions about the study around several key issues. These include the nature and location of the vulnerable study population, the social value of conducting the study, the risks and benefits to participants of participating in the study, and posttrial obligations of the investigators. In discussing how these questions were addressed as the study was designed and after it was initiated, we describe our attempts to wed sound scientific practices with meaningful ethical protections for participants.