CASE STUDY

The Bucharest Early Intervention Project

Case Study in the Ethics of Mental Health Research
Charles H. Zeanah, MD,* Nathan A. Fox, PhD,Þ and Charles A. Nelson, PhDþ

2009), but it involved training three project social workers to support

Abstract: The Bucharest Early Intervention Project is the first ever random- and monitor 56 foster homes. They were trained to encourage the en-
ized controlled trial of foster care as an alternative to institutional care for young hancement of social relationships between the foster parents and the
abandoned children. This article examines ethical issues in the conceptualization child and to oversee the quality of care in the foster home environment.
and implementation of the study, which involved American investigators con- These social workers received weekly consultation from experienced
ducting research in another country, as well as vulnerable participants. We or- psychologists in the United States throughout the life of the project to
ganize the discussion of ethical questions about the study around several key help them respond effectively to foster parents and the children they
issues. These include the nature and location of the vulnerable study population, cared for.
the social value of conducting the study, the risks and benefits to participants A total of 136 children between 6 and 31 months old who were
of participating in the study, and posttrial obligations of the investigators. In being raised in all of the six institutions for young children in Bucharest,
discussing how these questions were addressed as the study was designed and Romania, participated in the study. They were assessed compre-
after it was initiated, we describe our attempts to wed sound scientific practices hensively at baseline on a variety of cognitive, language, social, and
with meaningful ethical protections for participants. psychiatric measures, as well as measures of brain functioning
Key Words: Randomized clinical trial, institutional rearing, (Zeanah et al., 2003). These measures included psychological tests,
orphaned and vulnerable children. interactional assessments between caregiver and child, interactional
(J Nerv Ment Dis 2012;200: 243Y247) assessments between examiner and child, physical measurements
such as height and weight, and brain electrical activity measured
through electroencephalograms and event-related responses. After
baseline assessments, 68 children were randomly assigned to care as
THE RESEARCH PROJECT usual (continued institutional care), and 68 others, to placement into the
The Bucharest Early Intervention Project (BEIP) was a ran- foster family homes. There were no significant differences between
domized controlled trial of foster care as an alternative to institutional those who would go to foster care and those who would experience
care for young children conducted between 2000 and 2005 (Zeanah care as usual (continued institutional care) before randomization on
et al., 2003). The purpose of the study was to determine whether re- any of the measures assessed at baseline (Smyke et al., 2007).
moving young children from institutional care and placing them in In addition, 72 children with no history of institutional rearing
foster care would enhance their developmental outcomes as assessed were recruited from pediatric clinics in Bucharest to serve as a com-
through brain and behavioral functioning. Comprehensive develop- parison group for the children with histories of institutional rearing.
mental follow-up assessments of brain and behavioral functioning in This group was necessary to include because the investigation involved
children were completed when they became 8 years old and are un- measures that had not been used previously in Romania, and their
derway as they turn 12 years old. Three United States investigators performance allowed us to determine how typically developing Roma-
served as Principal Investigators (PIs), and they partnered with a non- nian children performed in relation with those who had experienced
governmental agency in Romania to complete assessments of infants institutional rearing. Not surprisingly, there were large differences be-
and children, create a foster care network, and develop an adminis- tween the children who had been institutionalized and those who had
trative structure that could support study personnel for the duration of not, but on virtually every assessment, Romanian children who had
the study. The scientific and humanitarian components of the study never been institutionalized performed similarly on assessments to
were supported largely by the John D. and Catherine T. MacArthur children in the United States (Smyke et al., 2007).
Foundation through the Research Network on ‘‘Early Experience and Although the overall pattern of results clearly favors the chil-
Brain Development,’’ chaired by Charles A. Nelson, PhD. dren placed in foster care, the effectiveness of the intervention varied
The chief goal in designing the intervention was to implement across developmental domains (Nelson et al., 2009). The results have
high-quality foster care for young abandoned children that was afford- examined the main effects of the intervention, the degree of catch-up
able, culturally sensitive, and replicable in other settings. There are or recovery among children with institutional rearing, and the ques-
compelling data substantiating that the quality of child-parent relation- tion of the timing of enhanced environments on outcomes.
ships in the early years predict important outcomes in later childhood Regarding the main effects of the intervention, for most do-
and beyond. The foster care model has been described in detail else- mains of development, foster care produced significant gains com-
where (Nelson et al., 2007, supplemental online material; Smyke et al., pared with care as usual. Furthermore, these results are probably
conservative estimates of the advantages of family care versus insti-
tutional care because we used the data analytic strategy known as
‘‘intent to treat.’’ This type of analysis compares groups of partici-
*Institute of Infant and Early Childhood Mental Health, Tulane University School
of Medicine, New Orleans, LA; †College of Human Development, University
pants based on the initial treatment intent rather than on the placement
of Maryland, College Park, MD; and ‡Developmental Medicine Laboratory, conditions the children experienced. Although, as the study contin-
Children’s Hospital Boston, Harvard Medical School, Boston, MA. ued, the care-as-usual group included children who were adopted
Send reprint requests to Charles H. Zeanah, MD, 1440 Canal Street TB 52, domestically and who were returned to their biological parents and
New Orleans, LA 70112. E-mail: [email protected].
Copyright * 2012 by Lippincott Williams & Wilkins
children who were placed in government sponsored foster care, this
ISSN: 0022-3018/12/20003-0243 group of children was considered for purposes of analysis as one
DOI: 10.1097/NMD.0b013e318247d275 groupVrandomized to remain in the institution.

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Zeanah et al. The Journal of Nervous and Mental Disease & Volume 200, Number 3, March 2012

Second, for most domains, the foster care children did not at- work training in 1969 on the grounds that no one had social problems
tain levels of functioning comparable with those of community-raised that the State could not handle.
Romanian children. This suggests that foster placement made pos-
sible some but not complete recovery after early deprivation. How-
ever, it is important to remember that the children placed in institutions ETHICAL ISSUES
had many risk factors that the never-institutionalized children did To discuss the ethical dimensions of BEIP, we begin by stating
not have, and this may well have contributed to their incomplete that the case involves American investigators conducting a study with
recovery. an extremely vulnerable population in a country with fewer protec-
Third, the timing of the intervention mattered for some do- tions for human subjects than the United States. The study addressed
mains but not others, compatible with sensitive periods in brain de- a number of scientific and policy questions. Among the scientific
velopment (Fox et al., 2010). That is, for brain activity and security questions was whether there were sensitive periods for the develop-
of attachment, children placed in foster care before 24 months had ment of specific cognitive and social skills such that young children
significantly better outcomes than did children placed after 24 months. who were living in institutions during these age periods would benefit
On the other hand, psychiatric symptoms was reduced by placing less from intervention than those removed from conditions of extreme
children in foster care, but earlier or later placement did not affect deprivation and placed into foster homes before the end of this sen-
results. Obviously, timing results have significant implications for sitive period. Among the policy questions addressed by the study was
policies regarding orphaned, abandoned, and maltreated children. which form of care is preferable for abandoned children (institutional
versus family-centered), even though there is widespread consensus
among most child protection professionals about the answer to that
BACKGROUND: CARE FOR ABANDONED question. In the United States, as discussed below, foster care has been
CHILDREN IN ROMANIA the preferred form of care for more than 100 years, and the consensus
Foster care barely existed in Romania at the time the study is clear that family care is preferable to institutional rearing for young
began. Poverty was widespread after the disastrous reign of the Roma- children.
nian dictator, Nicolae Ceausescu, who had attempted to pay off all of This case study of the BEIP is organized around a series of
Romania’s foreign debt in the 1980s, leading to food and supply ra- questions about the ethical soundness of the study, drawn from the
tioning. Worse, he had imposed coercive pronatalist policies on women concerns outlined above. In responding to the questions, we describe
of reproductive age, insisting that they have at least five children how we considered and addressed each of them, either before or during
(Kligman, 1998). When impoverished families were forced to have the study. Many of these issues have been discussed previously, and this
children they could not afford, many of them abandoned their children to account will draw from those discussions (Miller, 2009; Millum and
state-run institutions. In the Communist ideology in Romania, this was Emmanuel, 2007; Nelson et al., 2007; Wassenar, 2006; Zeanah et al.,
not stigmatized because the government suggested that the state could 2006a, b).
raise children more effectively than parents. As result, there were tens
of thousands of children being raised in state-run institutions. All of Study Population: Location
this was discovered by the Western media in 1990, months after Why was the study conducted in Romania? Couldn’t the study
the revolution and deposition of Ceausescu in 1989. Because of the be conducted in the United States?
sudden collapse of the regime, poverty actually increased in the early For more than 100 years, United States child welfare policy
1990s, and institutionalization of children increased as well. Ten years has endorsed that children should be raised in families rather than
later, when BEIP was started, Romania was still reforming the child in institutions and that if institutions are necessary, they should be
protection structure (as they continue to today) and grappling with large as family like as possible. As a result, there are few young children
numbers of institutionalized children and a steady stream of aban- placed in group settings in the United States. According to data
doned children. from the Child Welfare League of America (2007), less than 0.5%
In the Ceausescu era in Romania, and for many years after that, of children less than 3 years old in care in the United States are in
abandoned children were cared for in ‘‘Leagans’’ (meaning cradles), group-care settings, and virtually all of these are intended to be short-
that is, institutions for abandoned young children from birth to age term placements. Therefore, there were an insufficient number of
3 years. A rigid system of ‘‘child protection’’ was implemented. At young children in group care in the United States to make a study
age 3 years, the children were assessed by a psychiatrist and a psy- feasible. In addition, there is no policy debate in the United States
chologist, and based on results, they were sent either to children’s about the best approach for abandoned children, although group care
homes or to institutions for handicapped children. The former were is sometimes still used (Harden, 2002).
smaller group homes with rotating staffs in which the children had In contrast, in Romania at the time of the onset of the BEIP
some personal space and may have even attended public preschools. study, the question of foster care versus institutional care was far from
The latter were often large institutions with very limited resources, settled. In fact, the investigators were originally invited to conduct
rotating staff, and regimented care. Handicapped children, following the study by the Secretary of State for Child Protection in Romania
in the tradition of Soviet ‘‘defectology,’’ were considered damaged because of a debate there about the most appropriate care for aban-
and often ‘‘irrecuperable,’’ and they were merely housed with no efforts doned children. At the time of Ceaucescu’s ouster in the revolution
at remediation made (Tobis, 2000). of 1989, there were perhaps 170,000 children living in institutions
There had been some limited foster care in Bucharest in the in Romania (Rosapepe, 2001). Therefore, the question of how best
1990s, but these homes were mostly run by international adoption to care for these children was a significant policy dilemma. On one
agencies. Because international adoption from Romania was banned side of the debate were those who argued that institutional care had
by the government in 2001, these homes no longer existed when been practiced for more than 100 years and that trained professional
our project began. Government foster care was made possible by caregivers were preferable to untrained foster parents. In addition,
legislation passed in 1997, but it was implemented in other parts there was deep suspicion among some about the motives of foster
of Romania much more commonly than in Bucharest at that time. parentsVrumors of pedophilia or child trafficking were not uncommon
Therefore, creating a foster care network involved starting without among the people we talked with. On the other hand, others believed
an existing infrastructure and with social workers who had no pre- that Romania needed to close their institutions and move to family-
vious experience with child welfare. Ceausescu had banned social based care, as had been done in some other countries such as the

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The Journal of Nervous and Mental Disease & Volume 200, Number 3, March 2012 Case Study in Ethics of Research

United States and the United Kingdom. Publicity about the condi- United States, official policy had concluded many years ago that
tions of thousands of children housed in poorly staffed and materially foster care is more desirable than institutional care.
deprived institutions also created pressure for developing alternatives These considerations actually contain two different questions
to institutional care. about foster care versus institutional care. First, is there a consensus
We conducted the study in Romania because at the time, there about which form of care is preferable, and who shares that conclu-
were tens of thousands of children being reared in institutions there, sion? Second, how convincing are the data upon which expert opinion
because the best form of care for these children was a matter of debate rests? That is, is there a disconnect between the prevailing consensus
rather than a settled policy question, and because we were invited of expert opinion and what the evidence actually indicates?
originally by a government official who requested a scientific investi- With regard to the first question, deciding between institu-
gation to inform policy. tional care and foster care as a societal intervention for abandoned
children was decidedly not settled in Romania at the time the study
Study Population: Abandoned Children began. In fact, institutional care for orphaned, abandoned, and mal-
treated children had prevailed there for several hundred years, as it
How can we justify studying abandoned children? Who can
has much of the world. Therefore, the question is far from settled
consent for them and who will speak on their behalf with regard to
as a matter of policy, regardless of what United States psycholog-
research activities?
ical researchers or child welfare professionals may have concluded
It would be hard to find a more vulnerable population than
(Zeanah et al., 2006c). The BEIP was uniquely positioned to provide
preverbal abandoned children. In any research study involving min-
data relevant to the question of whether foster care offered advan-
ors, legal guardians, such as a child’s biological parents, must con-
tages over institutional care for children who were abandoned and
sent. For children lacking parents, there may be concern that their
placed in institutions in the Romanian context. With such data, we
legal guardians may be less vigilant about ensuring protection, par-
believed, Romanian policy makers could make more informed deci-
ticularly if the legal guardians are not emotionally invested in the
sions. The Romanian Secretary of State for Child Protection who invited
children as individuals. In Romania, local commissioners on child pro-
the study originally believed that if data from a study within Romania
tection were the legal guardians of abandoned children and had to pro-
favored foster care, skeptics about foster care would be more readily
vide consent for their participation.
convinced.
Clearly, research involving vulnerable children needs to pay
With regard to the second question, it is worth asking about
scrupulous attention to adequate protection. With regard to the BEIP
the database on which that opinion rests. It turns out that there were
study, there were two additional layers of protection for institution-
less than a dozen mostly small descriptive studies that had ever
alized children. The first was that institutional review boards (IRBs)
compared children raised in foster care with children raised in insti-
at each of the United States universities for the three PIs had to
tutions. All of them indicated that children in foster care were de-
approve the study before implementation. Two key questions con-
veloping more favorably than children in institutions and that there
sidered by the IRBs involving concerns about exploitation were who
were negative effects to being raised in an institution early in life
would provide informed consent for the institutionalized children in
(Zeanah et al., 2006c). On the other hand, none of the studies used
our study and whether the activities and procedures of the study en-
random assignment; hence, the selection of children for placement
tailed more than minimal risk.
into groups may have been systematically biased. It is plausible that
Given the difficulty in obtaining consent from the child’s bi-
children who were developing more favorably would be placed in
ological parents, consent had to be obtained by local commissioners.
families and that those with delays or who were handicapped would
In addition, the IRBs wanted evidence that the research would pro-
remain in institutions. On balance then, we concluded that the data-
vide either direct or indirect benefit to the study population. Mini-
base for this important policy question was remarkably thin.
mal risk, that is, risk that is comparable with routine daily activities,
Furthermore, Miller and Brody (2003) have argued that the
was also important for similar reasons. Vulnerable children certainly
principle of clinical equipoise is flawed and should not be applied
should not be exposed to risks that exceed those typically asked of
as a standard for ethical clinical trials. Clinical equipoise, they note,
family-reared children. For this reason, BEIP included only measures
equates clinical research with clinical care and holds investigators
and procedures that had been used with hundreds (or more) of chil-
studying participants to the same standards as clinicians providing
dren being raised by their biological parents. All three IRBs agreed
care to patients. Clinical research, they argue, is not a therapeutic
that the BEIP studied abandoned, institutionalized children because
activity devoted to the care of patients but rather is designed for an-
the scientific questions being addressed were focused squarely on the
swering scientific questions to produce knowledge that will be of
best interest of these children. In addition, all three IRBs at the home
benefit to society rather than to any individual participant.
institutions of each of the PIs’ universities reviewed and approved
Therefore, in our view, a randomized controlled trial was not
the protocols as involving no more than minimal risk, that is, the kind
only justifiable but also required to examine the question of which
of risks likely to be encountered in everyday life.
caregiving approach was most advantageous for young children who
In addition, caregivers (or foster parents) had to assent to the
were abandoned and placed in institutions. This knowledge was
specific activities and procedures involved in the study, although we
generated to benefit the larger society rather than each individual
cannot be sure how much protection this provided. The concern, of
participant.
course, is that in some cases, institutional caregivers also may have
lacked emotional investment in the children’s well-being. Risks and Benefits
How can we justify randomizing children to an intervention
Social Value: Equipoise that experts widely believe to be inferior (i.e., institutional care)?
Didn’t we already know that foster care is better than institu- Doesn’t this mean that the risk/benefit ratio was unfavorable for at
tional care? Was the study really necessary? least half of the participants? If the investigators got a clear sense
The principle of clinical equipoise is that there ought to be early on that foster care was more favorable, why not employ a ‘‘stop
genuine uncertainty among experts about whether a proposed inter- rule?’’
vention is better than standard care for research to be ethical. Why Here, an important question is whether the risks involved are
subject participants to any risk, one may ask, to conduct a study increased because of participation. This would raise significant con-
when the outcome is all but a foregone conclusion? As noted, in the cerns, particularly because BEIP involved a vulnerable population.

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Zeanah et al. The Journal of Nervous and Mental Disease & Volume 200, Number 3, March 2012

In fact, half of the study population in BEIP were randomized tion and found that foster care appeared to be beneficial, instead of
not to receive the intervention. Nevertheless, this was a continuation stopping the project, we arranged to report results at a press conference
of the current government-provided interventionVinstitutional care. to which we invited ministers of departments concerning child well-
They were placed in institutions, not by the BEIP but by the gov- being (e.g., Ministry of Health, Ministry of Child Protection, Ministry
ernment, because they had been abandoned. In addition, no child re- of Education). Our presentations at the press conference were intro-
mained in institutional care because of the study. If children had been duced by the United States Ambassador to Romania, who urged that
assigned to remain in institutional care for purposes of the study, the the government of Romania make use of the findings. We also ob-
risk-benefit ratio would clearly be unfavorable for that group. How- tained funding for and hosted continuing education meetings in 2002
ever, that was not the case for BEIP. Throughout, we used a rule of and 2003. To these meetings, we invited child protection professionals,
noninterference regarding placement. That is, whatever plans for a child development specialists, mental health professionals, healthcare
child’s placement that were made by the local Commissions on Child professionals, and neuroscientists from all over Romania. We presented
Protection were implemented without regard to their study partici- some of our early findings at those meetings.
pation. This was true for all 136 children, and indeed, some children
in the foster care group also were returned home to their biological Posttrial Obligations
parents or adopted domestically. What about after the study ended? Isn’t it a problem to im-
The Commissions reviewed each child’s placement every 3 plement a study and then after obtaining results, withdraw the
months and made decisions about custody and placement as usual. intervention?
Participation in the BEIP did not limit or affect in any way the re- There are reasonable concerns about investigators who study
moval of children in the institutional group from institutions or their high-risk or vulnerable populations, collect the data they need, and
placement in foster care, if foster homes other than those we supported then leave the study population with little to show for their partici-
became available. In fact, at the time of the assessment at 54 months pation when the study ends. From the outset, we were determined
of age, 28 children in the care as usual group were still institution- to avoid this pitfall.
alized, 9 had been adopted within Romania, 18 were in government We enacted two approaches to ensure that the study popula-
foster care that did not exist when the study began, 11 had been tion and others would enjoy benefits beyond the life of the study. First,
returned to their biological families, and 2 were placed with extended we attempted to ensure that no child randomized to foster care would
family. be returned to institutional care after the study ended. We attempted
Furthermore, if the research had not been conducted, children to negotiate agreements with each of the sectors in Bucharest (gov-
in the intervention group would have experienced more time in in- ernmental districts) that they would assume support of foster homes
stitutional care. Foster care was not an option at the time the study after the study concluded. Four of the five sectors agreed to this
began for abandoned young children living in Bucharest. No research condition. In fact, at the formal conclusion of the trial, support for all
participants had their risk increased by the research, except for the of the remaining children in BEIP foster homes had been transferred
risks associated with foster placement. In fact, because half of the to the local sectors in Bucharest. Since the formal intervention ended
children were randomized to foster care, arguably, they were better in 2005, a set of twins has been placed in a ‘‘social’’ apartment (four
off than if the study had not been conducted. to six children living in an apartment in a private apartment complex
An additional factor to consider in assessing risk benefit ratios cared for by rotating caregivers), and two others have been placed in
is the overall benefit to society. If risks to participants are low, as they institutions for handicapped children because of unmanageable be-
were in BEIP (because, without the study, all of the children would havior and serious aggression. At the time of the assessment at age
have experienced extended institutional care), then the advantages that 8 years, of the 68 children originally placed on BEIP foster homes,
accrue from knowledge gained from research becomes an important 35 remain with their same foster parents, and 6 of them have been
consideration. In Romania, for example, although much progress formally adopted by their foster parents.
has been made in developing alternatives for abandoned children, A second effort to meet posttrial obligations is that the inves-
thousands of children remain in institutions. How best to care for these tigators obtained $900,000 in start-up funding for the creation of a
children is an especially important question there. Therefore, the Child Development Institute in Bucharest. The vision is that this In-
results of this study have many potential benefits for the larger pop- stitute will oversee clinical services, research, and policy proposals
ulation of institutionalized children in Romania and perhaps those in relevant to high-risk children. We obtained matching funds from one
other parts of the world as well. Policy makers concerned about how of the Sector 1 in Bucharest, on the grounds of what was once per-
best to enhance the long-term outcomes of abandoned children should haps the largest institution for young children in Romania. The place
attend closely to research comparing different forms of care. Fur- has been renovated, and the opening ceremony was scheduled for
thermore, there are millions of abandoned children worldwide, and October 2011. We are working with Romanian partners to attempt
many are being raised in institutions (Browne et al., 2006; NGO to procure sustainable funding for this effort that, in our view, could
Working Group on Children Without Parental Care, 2006; Zeanah contribute meaningfully to Romania’s child welfare needs.
et al., 2006c). The BEIP results, with appropriate cross cultural cau- In addition to these measures, of course, we have generated data
tions, have implications for many of these children. that we believe has proximal application in Bucharest and Romania,
In studies of drugs developed to treat a specific medical con- and distal applications in other counties in which young children are
dition, randomized controlled trials are stopped if preliminary data being raised in institutions.
suggests clear advantages for the drug being evaluated. At that point,
the treatment is made available to those participants who were orig-
inally randomized to the placebo arm of the trial. This ensures that CONCLUSIONS
participating in the trial does not preclude or unnecessarily postpone Research with vulnerable populations should be guided by eth-
obtaining effective treatment. We were not able to use a ‘‘stop rule’’ ical principles that then must be translated into specific cultural, his-
because of the cost of foster care and the limitations of project funding. torical, and political contexts. Making the guiding principles explicit
We spent about half of our funds on foster care and about half on can help clarify decisions and practices, which is especially important
research. Any increase in foster care funding would necessarily reduce when working with vulnerable populations. For these reasons, ethi-
the research component and weaken what could be learned from the cal considerations were widely discussed from the inception of the
project. When we analyzed early returns of the effects of the interven- BEIP to ensure that ethical principles in international research with

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The Journal of Nervous and Mental Disease & Volume 200, Number 3, March 2012 Case Study in Ethics of Research

vulnerable populations were applied and monitored throughout the DISCLOSURE

implementation of the intervention and during follow-up assessments. The authors declare no conflict of interest.
The questions throughout this article were discussed at length within
our group and with a number of other investigators as well as with
three university IRBs. The reasoning that we used is described above REFERENCES
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