The Bucharest Early Intervention Project: Case Study in the Ethics of Mental Health Research

May combine two claims.

The overall results favored foster care, but the intervention's effectiveness differed by developmental domain.

“Though the overall pattern of results clearly favors the children placed in foster care, the effectiveness of the intervention varied across developmental domains (Nelson et al., 2009).”

• cites Nelson et al., 2009 sourceNot checked — no full text of the source

May combine two claims.

Foster care reduced psychiatric symptoms, but whether placement occurred earlier or later did not change that result.

“On the other hand, psychiatric symptomatology was reduced by placing children in foster care, but earlier or later placement did not affect results.”

May combine two claims.

At the 54-month assessment, 28 care-as-usual children remained institutionalized, 9 were adopted in Romania, 18 were in government foster care, 11 had returned to biological families, and 2 were with extended family.

“In fact, at the time of the assessment at 54 months of age, 28 children in the care as usual group were still institutionalized, 9 had been adopted within Romania, 18 were in government foster care that did not exist when the study began, 11 had been returned to their biological families, and 2 were placed with extended family.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The case involved American researchers studying an extremely vulnerable population in a country with weaker human-subjects protections than the United States.

“To discuss the ethical dimensions of BEIP, we begin by stating that the case involves American investigators conducting a study with an extremely vulnerable population in a country with fewer protections for human subjects than the US.”

Probably not a substantial claim: may not pass S2 (checkable).

The timing findings have important policy implications for orphaned, abandoned, and maltreated children.

“Obviously, timing results have significant implications for policies regarding orphaned, abandoned, and maltreated children.”

May combine two claims.

According to Child Welfare League of America data, under 0.5% of U.S. children under age 3 in care are in group settings, and nearly all such placements are short-term.

“According to data from the Child Welfare League of America (2007), fewer than 0.5% of children less than 3 years old in care in the U.S. are in group care settings, and virtually all of these are intended to be short-term placements.”

• cites Child Welfare League of America (2007)Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

Institutionalized children had many risk factors absent in never-institutionalized children, which may have contributed to their incomplete recovery.

“However, it is important to remember that the children placed in institutions had many risk factors that the never institutionalized children did not have, and this may well have contributed to their incomplete recovery.”

May combine two claims.

The BEIP was an RCT that tested foster care against institutional care for young children, running from 2000 to 2005.

“The Bucharest Early Intervention Project (BEIP) was a randomized controlled trial of foster care as an alternative to institutional care for young children conducted between 2000 and 2005 (see Zeanah et al., 2003).”

• cites Zeanah et al., 2003 sourceNot checked — no full text of the source

May combine two claims.

The timing of intervention mattered in some domains but not others, a pattern consistent with sensitive periods in brain development.

“Third, timing of the intervention mattered for some domains but not others, compatible with sensitive periods in brain development.”

Classified as probably not a substantial claim.

The investigators believed such data would let Romanian policy makers make better-informed decisions.

“With such data, we believed, Romanian policy makers could make more informed decisions.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Romania, local child-protection commissioners were the legal guardians of abandoned children and had to consent to their participation.

“In Romania, local commissioners on child protection were the legal guardians of abandoned children and had to provide consent for their participation.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

After early analyses suggested foster care was beneficial, the investigators held a press conference for government ministers to report the results.

“Instead, when we analyzed early returns of the effects of the intervention, and we found that foster care appeared to be beneficial, we arranged to report results at a press conference to which we invited ministers of departments concerning child well being(e.g., Ministry of Health, Ministry of Child Protection, Ministry of Education).”

May combine two claims.

The non-intervention group was not placed in institutions by BEIP; their situation continued as before.

“Nevertheless, this was a continuation of their current life circumstance-- they were not placed in institutions by the BEIP.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Romania's Secretary of State for Child Protection originally invited the investigators because of a local debate about the best care for abandoned children.

“In fact, the investigators were originally invited to conduct the study by the Secretary of State for Child Protection in Romania because of a debate there about the most appropriate care for abandoned children.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Millions of abandoned children exist worldwide, and many are raised in institutions.

“Furthermore, there are millions of abandoned children worldwide, and many are being raised in institutions (Browne et al., 2006; NGO Working Group on Children without Parental Care, 2006; Zeanah et al., 2006).”

• cites Browne et al., 2006 sourceNot checked — no full text of the source
• cites NGO Working Group on Children without Parental Care, 2006Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Zeanah et al., 2006Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The U.S. had no policy debate about the best care for abandoned children, though group care was sometimes used.

“In addition, there is no policy debate in the US about the best approach for abandoned children, although group care is sometimes still used (Jones Harden, 2002).”

• cites Jones Harden, 2002 sourceNot checked — no full text of the source

May combine two claims.

The investigators chose Romania because tens of thousands of children were institutionalized there, the best care was debated rather than settled, and a government official had invited a scientific study to inform policy.

“We conducted the study in Romania because at the time there were tens of thousands of children being reared in institutions there, because the best form of care for these children was a matter of debate rather than a settled policy question, and because we were invited originally by a government official who requested a scientific investigation to inform policy.”

Probably not a substantial claim: may not pass S3 (load-bearing).

They obtained matching funds from one Bucharest sector to renovate space now housing the Institute.

“We obtained matching funds from one of the sectors in Bucharest for renovation of space that now houses the Institute.”

Probably not a substantial claim: may not pass S3 (load-bearing).

They obtained start-up funding for a Child Development Institute in Romania.

“We also obtained start up funding for the creation of a Child Development Institute in Romania.”

May combine two claims.

Ethical considerations were discussed widely from BEIP's inception and monitored during intervention and follow-up.

“Ethical considerations were widely discussed from the inception of the BEIP and were monitored throughout the implementation of the intervention and during follow-up assessments.”

May combine two claims.

The noninterference rule applied to all 136 children, and some foster-care-group children were returned home or adopted domestically.

“This was true for all 136 children, and indeed, some children in the foster care group also were returned home to their biological parents or adopted domestically.”

May combine two claims.

Because none of the prior studies used random assignment, selection into groups may have been systematically biased.

“On the other hand, none of the studies used random assignment, hence the selection of children for placement into groups may have been systematically biased.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Around the 1989 revolution that removed Ceaucescu, roughly 150,000 Romanian children were living in institutions.

“At the time of Ceaucescu’s ouster in the revolution of 1989, there were perhaps 150,000 children living in institutions in Romania (Rosapepe, 2001).”

• cites Rosapepe, 2001Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

At the trial's formal end, all remaining children in BEIP foster homes had been transferred to the government, mostly because the government took over support.

“In fact, at the formal conclusion of the trial, all the remaining children in BEIP foster homes had been transferred to the government, mostly because the government assumed support of the foster homes formerly supported by the Project.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Because consent from biological parents was difficult to obtain, local commissioners had to provide consent.

“Given the difficulty in obtaining consent from the child’s biological parents, consent had to be obtained by local commissioners.”

May combine two claims.

They sought agreements with each Bucharest sector to take over foster-home support after the study; four of five sectors agreed.

“We attempted to negotiate agreements with each of the sectors in Bucharest (governmental districts) that they would assume support of foster homes after the study concluded. Four of the five sectors agreed to this condition.”

Probably not a substantial claim: may not pass S3 (load-bearing).

IRBs at each of the three PIs' U.S. universities had to approve the study before it began.

“The first was that Institutional Review Boards at each of the U.S. universities for the three PIs had to approve the study prior to implementation.”

Classified as probably not a substantial claim. May combine two claims.

Miller and Brody argued that clinical equipoise is flawed and should not be the standard for ethical clinical trials.

“Furthermore, Miller & Brody (2003) have argued that the principle of clinical equipoise is flawed and should not be applied as a standard for ethical clinical trials.”

• cites Miller & Brody (2003) sourceNot checked — no full text of the source

May combine two claims.

The study used a rule of noninterference, so local Commissions' placement decisions were made without regard to study participation.

“In fact, no child remained in institutional care because of the study; we employed a rule of noninterference regarding placement. That is, whatever plan for a child’s placement that was made by the local Commissions on Child Protection were implemented without regard to their study participation.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All three IRBs reviewed and approved the protocols as involving no more than minimal risk.

“In addition, all three Institutional Review Boards at the home institutions of each of the PIs universities reviewed and approved the protocols as involving no more than minimal risk, that is, the kind of risks likely to be encountered in everyday life.”

May combine two claims.

Those studies all found that foster-care children developed more favorably and that early institutional rearing had negative effects.

“All of them indicated that the children in foster care were developing more favorably than children in institutions and that there were negative effects to being raised in an institution early in life (Zeanah, Smyke & Settles, 2006).”

• cites Zeanah, Smyke & Settles, 2006Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Caregivers accompanying the child had the final say on stopping a procedure because of the child's distress.

“Research assistants made determinations about whether to persist, but caregivers accompanying the child always had the final word about terminating the procedure due to the child’s distress.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The ethical questions were discussed at length within the group, with other investigators, and with three university IRBs.

“The questions posed above were discussed at length within our group and with a number of other investigators as well as with three university IRBs.”