In an earlier post, I looked at a research study by Nelson et al. [1] on how the cognitive development of young abandoned children in Romania was affected by being raised in institutional versus foster care conditions. Specifically, I examined the explanation the researchers gave to argue that their work was not only scientifically sound but also ethical.
In this post, I examine the accompanying policy forum article, Millum and Emmanuel, “The Ethics of International Research with Abandoned Children” [2]. Millum and Emanuel are in the Department of Bioethics at the Clinical Center of the National Institutes of Health. As such, it’s not unreasonable to assume that they are not coming to their understanding of this research — and to the question of whether it rises to the appropriate ethical level — from the point of view that good science should trump all other interests.

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The Neurocritic alerted me, in a comment on an earlier post, to a pair of papers in the 21 December 2007 issue of Science that raise some difficult ethical questions about what sorts of research are permissible. Quoth the Neurocritic:

This may be a little off-topic, but I was wondering if you read this article in Science, beginning of abstract pasted below.
In a randomized controlled trial, we compared abandoned children reared in institutions to abandoned children placed in institutions but then moved to foster care. Young children living in institutions were randomly assigned to continued institutional care or to placement in foster care, and their cognitive development was tracked through 54 months of age.
Rather horrifying! Can you imagine this experiment being performed in a first- (or second-)world country in the 21st century? But the title of the paper is:
Cognitive Recovery in Socially Deprived Young Children: The Bucharest Early Intervention Project
Is it now OK to perform this experimental intervention, since it’s in Romania? …
The authors of the study, Nelson et al., do have a lengthy discussion of ethical issues within the paper (e.g., the secretary of state for child protection in Romania invited them to do the study, the IRBs at Minnesota, Tulane, and Maryland [PI home institutions] approved the study, etc.). However, to me it seems to set off alarm bells in terms of ethics. I’m definitely not a developmental psychologist, but this statement seems odd:
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 (27). 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… [Is the superiority of foster care really in doubt?]

In this post, I’ll look at both Nelson et al., “Cognitive Recovery in Socially Deprived Young Children: The Bucharest Early Intervention Project”. [1] In a second post in the not-too-distant future, I’ll look at the accompanying policy forum article, Millum and Emmanuel, “The Ethics of International Research with Abandoned Children” [2]. (I’m breaking it up into two posts because otherwise it may require you a full pot of coffee, rather than a mug, to get through it all.) My aim in these two posts will be to lay out the recognized ethical guidelines for research with human subjects as they apply to the Bucharest Early Intervention Project (BEIP), and to identify the worries we might raise about this kind of research — and, by extension, with the prevailing standards.

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