- BIOETHICS FORUM ESSAY
Romanian Orphans Study: Investigators Respond to Ethical Questions
We appreciate having an opportunity to respond to the commentary on the Bucharest Early Intervention Project (BEIP) by Joseph Fins. We respect his status as a leading bioethics authority, although we are dismayed by the content and tone of his critique. As the three principal investigators of BEIP, we feel it is important to clarify a number of points that he raised.
We begin by acknowledging the complex nature of our project and the difficult ethical issues that it raises. We understand that not everyone will view the project in the same way. Nevertheless, Professor Fins’s analogies to infamous studies are inaccurate, misplaced, and inflammatory. A review of the facts about BEIP may be helpful in illuminating our points of agreement and disagreement.
1. The Romanian context
Professor Fins correctly identifies the Ceausescu legacy in child protection as inhumane and toxic. Ten years after the revolution, the country was struggling with how best to care for the estimated 170,000 children that the regime had housed in institutional settings, according to a report in 2001 by James C. Rosapepe, the U.S. Ambassador to Romania. Without getting into the complexities of Ceausescu’s system, the turn of the twenty-first century was a time when Romanian government officials still were faced with a huge crisis. In addition to the children already institutionalized, Romanian children were still being abandoned at a rate comparable to that of the mid-1980s, concluded “The Situation of Child Abandonment in Romania,” a report by the Romanian Ministry of Health and UNICEF in 2005.
The then-secretary of state for child protection, Cristian Tabacaru, invited us to conduct an intervention study that would provide valuable data about whether or not we could enhance children’s development by removing children from institutions and placing them into foster care. He had encountered resistance to this idea within the Romanian government because there was a belief among many officials that institutional care was superior to foster care for abandoned children. Even after 2000, we routinely encountered professionals who were deeply suspicious of foster care on the grounds that it was related to trafficking and other abuses. These same individuals believed that children were better off in institutions. We established our study within this context: institutional care was standard, authorities were not supportive of alternatives such as foster care, and the government officials who invited us wanted a demonstration of the efficacy of transfer into foster care from institutions.
It is worth emphasizing that institutional rearing of young children is hardly limited to Romania. Estimates range from 2,000,000 to 8,000,000 children worldwide that are in institutions, according to reports from the Better Care Network and Save the Children. Institutional rearing is widespread in Central and South America, Africa, and Asia. Though Eastern Europe has gotten most of the media attention, a surprising number of young children are being raised in institutions all over Western Europe, found a survey by Kevin Browne and colleagues in 2005 for the Better Care Network.
Having visited institutions for young children in many other countries, we found that the similarities among them are more striking than the differences. The documentation of problems in children is also similar, whether in studies of institutionalized children in Russia, the United Kingdom, or Lebanon. Given that this is one of the most widespread forms of intervention for orphaned, abandoned, and maltreated children worldwide, it is clearly not explained merely as a product of the Romanian totalitarian state.
2. Children were harmed and exploited.
There is absolutely no evidence that any child was harmed by participation in the BEIP study. This study was judged by four institutional review boards (IRBs) to expose children to no more than minimal risks. Four points need to be made.
First, if we had not conducted the study, all of the children would have grown up in the “toxic” environment of large and impersonal institutions that Professor Fins rightfully decries.
Second, we did not prolong institutional care for any child in the study. We also did not ask parents to consent to continuing placements of children in institutions. Indeed, biological parents could, in coordination with Romanian Child Protection authorities, take their children back home and out of the institution. This happened to children in our study who were randomized to care as usual and to foster care. We did not use children to further the interest of science.
Professor Fins criticizes our study for being deferential to Romanian standards—the point is that we followed Romanian law by not interfering with any placement decisions made by local authorities charged with making these decisions. The lone exception to our rule of noninterference was that we advocated that children we placed into BEIP foster care not be returned to institutions at the conclusion of the trial. Instead, the local sectors agreed to assume management of the foster homes that we had created and supported. Thus, the argument that we “exploited” or “sacrificed” the children by studying them is blatantly incorrect.
Third, Romania was selected as the study site because the questions the study addressed were pressing there—not because the children lacked advocates and could be exploited.
Fourth, one can debate the correct balance of our allocation of resources, but it is clear that our research project provided what is widely, but not universally, considered to be a superior form of child care for 68 children. They were placed in foster family homes and not returned to institutional care.
In sum, our research did not harm or exploit any children, and beyond the likely benefits to those children randomized to foster care, it contributed to the potential (and, we would argue, realized) benefits to many children in Romania and beyond.
Professor Fins objects strenuously to randomizing children to foster care and institutional care. He argues that, instead, all children should have been placed in foster care and that regression analyses should have been run to document improvement. This design works well for documenting individual differences in recovery and, indeed, has been a strategy we have used to examine certain questions. Nevertheless, because randomization is the only study design that allows one to draw causal conclusions, BEIP has been widely cited in efforts to eliminate institutional rearing (such as at the European Parliament Experts Roundtable on children in institutions, the U.S. Government Evidence Summit on Protecting Children Outside of Family Care, and “The Development and Care of Institutionally Reared Children,” an article in the journal Child Development Perspectives based on the Leiden Conference on the Development and Care of Children without Permanent Parents.)
4. Passivity in the Face of Transgressions
Professor Fins suggests that not objecting to the unethical dimensions of our study is analogous to passivity in the face of evil and that he was “worried that something terrible had happened and that no one had noticed.” Though he is careful to imply that such problems may be hidden in plain sight, we assert that the ethical dimensions of BEIP have been extensively scrutinized—by four university IRBs in the United States, by an Ethics Commission appointed by the Romanian government, by noted bioethicists (Franklin G. Miller, 2009;Joseph Millum and Ezekiel J. Emanuel, 2007), and by two different study sections reviewing grants for the National Institutes of Health.
It appears that Professor Fins disagrees with other respected medical bioethicists regarding, first, whether equipoise should determine the ethical nature of a study and, second, whether equipoise did or did not exist in our study (see Miller, 2009; Franklin G. Miller and Howard Brody, 2003; Millum and Emmanuel, 2007). The question of how to intervene with abandoned, institutionalized children was decidedly not settled in Romania at the time the study began, much as it is still not settled in many parts of the world.
BEIP was uniquely positioned to provide data relevant to the question of whether foster care offered advantages over institutional care for children who were abandoned and placed in institutions in the Romanian context. With such data, we believed, Romanian policy-makers could make more informed decisions. In fact, this is exactly what happened. Romania banned the institutionalization of children under the age of two in 2004. Government foster care has expanded dramatically. Thousands of infants and children who would have been placed into institutions are now placed into family care. BEIP is not, of course, the only reason for Romanian’s increasing embrace of foster care, but we have reason to believe it significantly contributed to this decision (see Nelson, Fox, & Zeanah, Romania’s Abandoned Children: Deprivation, Brain Development and the Struggle for Recovery, to be published in December, for interviews with Gabriella Coman, former secretary of state for child protection in Romania, and Bogdan Simion, president of the Federation of NGOs for Children in Romania).
It is hard to imagine a more vulnerable study population than infants and children who have been abandoned by their parents. Meticulous ethical scrutiny of this project is not only warranted—it is essential. The study was not aimed at determining whether institutions are bad or not. It was aimed at discovering whether removing children from institutions and placing them into families could remediate the deficits incurred by previous early experiences. Science, in our view, can and should be used to help children. BEIP harmed no child and arguably has contributed to the well-being of countless children by providing the strongest evidence to date for advocating for alternative, noninstitutional forms of care for abandoned children.
Nathan A. Foxis Distinguished University Professor at the University of Maryland, College Park. Charles H. Zeanah is Sellars-Polchow Chair in Psychiatry at the Tulane University School of Medicine. Charles A. Nelson is the Richard David Scott Chair of Pediatric Developmental Medicine Research at Children’s Hospital Boston and Harvard University.
Posted by Susan Gilbert at 11/05/2013 10:21:21 AM |
Published on: November 5, 2013
Published in: Clinical Trials and Human Subjects Research