Ethical considerations in international research collaboration: The Bucharest early intervention project.

The Bucharest Early Intervention Project (BEIP) is the first ever randomized controlled trial of foster care as an alternative to institutional care for young children. It involved a collaboration between American investigators and Romanian health and child protection professionals. We present a brief description of the Romanian context and the project itself before discussing a number of ethical issues raised by the project. Organized around a discussion of exploitation, risk/benefit ratio, and cultural sensitivity, we evaluate a number of ethical issues involved in the BEIP using the Ethical Clinical Research Framework and the Fair Benefits Framework. Based on this review, we conclude that notwithstanding challenging ethical dilemmas, the benefits of the project outweighed its risks. Throughout the planning and implementation of the project, ethical issues were a central focus of discussion among the investigators and in the collaboration between Americans and Romanians. Thoughtful discussions from multiple perspectives are necessary to conduct research that is ethically sound and scientifically meaningful.