When is Research Socially Valuable? Lessons From the Bucharest Early Intervention Project: Commentary on a Case Study in the Ethics of Mental Health Research

For research to be ethical, it must be designed to answer socially valuable questions. Studies without social value do not justify exposing participants to risks (Emanuel et al., 2000). The Bucharest Early Intervention Project (BEIP) offers important insights about the social value of research. The BEIP randomized 136 institutionalized children aged between 6 and 31 months to foster care or continued institutional care. Whereas countries like the United States had long adopted foster care as the supposedly superior alternative, tens of thousands of Romanian children were raised in institutions when the study was initiated, with no system of foster care in place. The BEIP thus addressed an important public health problem in Romania. However, as the investigators noted (Zeanah et al., 2012), it is not obvious that the BEIP addressed an unresolved problem. The study was designed to evaluate whether young institutionalized children recover from early deprivation after being transferred to foster care. Specifically, the goal was to identify any sensitive periods of cognitive and psychological development after which recovery becomes more difficult. This was unknown at the time (Nelson et al., 2007). However, the main publication from the study concludes that ‘‘discovering whether such a period truly exists or determining the borders that delineate it would likely require a larger sample size with a broader range at intervention onset’’ (Nelson et al., 2007). Therefore, the BEIP primarily shows that ‘‘the younger a child (I) when placed in foster care, the better the outcome’’ (Nelson et al., 2007). However, is this a new finding? Previous studies about the outcomes of institutional versus foster or family care have had methodological limitations (Nelson et al., 2007). When initiating the BEIP, its investigators nonetheless believed there were ‘‘compelling data [emphasis added] substantiating that qualities of the child parent relationships in the early years are predictive of important outcomes in later childhood and beyond’’ (Zeanah et al., 2011). This suggests, from a strictly scientific point of view, that the BEIP did not address an unresolved public health problem. However, it would be premature to conclude that the BEIP lacked social value. Research in medicine and public health is, above all, justified by its instrumental value for improving health. The BEIP clearly had instrumental value for improving the health of abandoned children in Romania. When the study was initiated, Romanian policy makers disagreed about the benefits of foster care. Assuming that decision makers would respond to scientific evidence, the BEIP had the potential to improve the health of these children. This line of thought suggests that we should broaden our understanding of social value. The requirement that socially valuable research should address an unresolved scientific, clinical, or public health problem are due, however should be extended to include states of practicalVnot merely scientificVuncertainty. A few words of caution about this proposal. First, it is important to distinguish legitimate from illegitimate sources of practical uncertainty. In the case of the BEIP, the available evidence about the benefits of institutional versus foster care was ‘‘remarkably thin’’ (Zeanah et al., 2012) and thus constituted legitimate uncertainty. In contrast, superstition against research results from other countries would be an illegitimate source of practical uncertainty that would not justify conducting further research. Second, practical uncertainty can justify only limited risks to individual research participants. When a research question is settled from a scientific point of view, participants should not be exposed to significant risks solely to gather more robust data. Third, as in the BEIP, research participants should not be made worse off than they would have been outside the study. Fourth, the research results should be likely to overcome practical uncertainty. For example, the Romanian Secretary of State for Child Protection had invited the BEIP investigators to conduct the study, expecting that skeptics about foster care would be convinced further by the results. Fifth, other ways of overcoming CASE STUDY