I appreciate the thoughtful responses to my essay on the ethics of the Bucharest Early Intervention Project (BEIP), from its investigators, Drs. Fox, Zeanah and Nelson and from Dr. Millum, one of the bioethicists who had defended their study design.
Let me begin by considering how Zeanah, Koga, Simion, Stanescu, Tabacaru and Nelson for the BEIP Core Group responded , in 2006, to an ethical critique that year by Douglas R. Wassenaar from the Infant Mental Health Journal. After raising some important methodological issues about blinding in the randomized clinical trial design, Wassenaar asks why provisions were not included in the original BEIP protocol for transferring children out of the institutions if foster care was “proved” superior in the context of the study. He asked what would be done with the other children left behind in the institutions:
The authors (the BEIP investigators) describe the financial constraints impacting on the study and the institutional context, particularly where the authors mention that local and national authorities could not guarantee that the results of the study would be nationally implemented if the findings favored foster care, as they did. This is clearly beyond the resources of the investigators. However, it would have been valuable to know if the investigators tried to negotiate foster care placements for the institutional control group if the intervention were shown to be effective. Although considerable, the financial implications of this seem within the realm of persuasive negotiation and advocacy, and ethically very important. No evidence is presented of such efforts, and we are left with the impression that the approximately 67 control subjects, subject to the batteries of physical and psychosocial evaluations over 4 years, languish in these institutions to this day.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.