As you can see from the abstract linked above, none of the authors is affiliated with a Romanian institution; however, it comes clear from the full text that they were greatly helped (and initially invited to do the study) by the Romanian authorities, which is a very pleasant surprise; I must confess that I would have been (and in fact, still am, to a certain degree…) very pessimistic inasmuch cooperation of Romanian authorities is concerned in such cases (perhaps this one here went through just fine given the huge importance of the topic and continuing international pressure etc.). I copy-paste below the fragment depicting the chronological interaction with the Romanian authorities in context and parts of the crucial ethical considerations for such a study:
First, our study was initiated at the invitation of the then–secretary of state for child protection in Romania and was approved by the local commissions on child protection in Bucharest, the Romanian ministry of health, and, in 2002, by an ad hoc ethics committee comprising appointees from several government and Bucharest University academic departments. It was therefore done with the participation and approval of local authorities. Second, the institutional review boards (IRBs) of the home institutions of the three principal investigators (the University of Minnesota, Tulane University, and the University of Maryland) approved the project. Third, we implemented a policy of noninterference with placement of children in both groups into alternative family care environments, leaving those decisions to Romanian child protection authorities (according to Romanian law). The only exception to the noninterference rule was that we ensured that no child placed in foster care as part of the randomization process would ever be returned to an institution […]. Fourth, after our preliminary results began to suggest positive benefits of foster care, we held a press conference to announce the results of our investigation. Key ministries in the Romanian government were invited to attend and sent representatives to this meeting. The then–U.S. ambassador to Romania (who was briefed in advance about our findings) gave the opening remarks at the conference. Fifth, although the usefulness of clinical equipoise is controversial among bioethicists […], a reasonable interpretation of clinical equipoise supports the research design in this project. Clinical equipoise is the notion that there must be uncertainty in the expert community about the relative merits of experimental and control interventions such that no subject should be randomized to an intervention known to be inferior to the standard of care […]. Because of the uncertainty in the results of prior research, it had not been established unequivocally that foster care was superior to institutionalized care across all domains of functioning, especially with respect to how young children initially placed in institutional care function when placed in foster care as compared with children who remain in the institutional setting. Moreover, at the start of our study there was uncertainty about the relative merits of institutional and foster care in the Romanian child welfare community, with a historical bias in favor of institutional care. Additionally, given that the study was invited by Romanian authorities and conducted there, with the aim of guiding child welfare policy in Romania, it made sense to assess the study in view of the local standard of care, which was institutional care. The study also presented no more than minimal risk to the subjects; specifically, children assigned to the IG continued to receive the same care as if the study had not been conducted, and the measures we used have all been used for many years in developmental science research. Lastly, we were aware from the outset of the policy implications of our work, and as the study progressed we made our results available to government officials and child protection professionals. Indeed, several years after our study began, the Romanian government passed a law that prohibits institutionalizing children less than 2 years old, unless the child is severely handicapped.
Three main findings emerge from this study. First, as we have previously reported […], children reared in institutions showed greatly diminished intellectual performance (borderline mental retardation) relative to children reared in their families of origin. Second, as a group, children randomly assigned to foster care experienced significant gains in cognitive function. Lastly, at first glance our findings suggest that there may be a sensitive period spanning the first 2 years of life within which the onset of foster care exerts a maximal effect on cognitive development. However, a closer reading of our analyses suggests a more parsimonious conclusion: That the younger a child is when placed in foster care, the better the outcome. Indeed, there was a continuing “cost” to children who remained in the institution over the course of our study. These results are compatible with the notion of a sensitive period, but discovering whether such a period truly exists or determining the borders that delineate it would likely require a larger sample size with a broader age range at intervention onset.
The results of this study have implications for child welfare because they suggest that placement in families is more advantageous for cognitive development in infants and young children than placement in institutional settings. For countries grappling with how best to care for abandoned, orphaned, and maltreated young children, these findings deserve consideration. The results also indicate that previously institutionalized children’s cognitive development benefits most from foster care if placement occurs relatively early in a child’s life.
If you want to read more on the topic of this post: the link to the full Science report (you need a subscription to Science to access it). Read also a summary with further comments regarding ethical considerations, on 60-seconds-science (I do not agree with the author’s remarks, concluding in ‘I’m not sure why this study was necessary’, but I leave further discussions here for some other time). Finally, read also a short article on ethical guidelines concerning international research with abandoned children (again, subscription to Science required).