Journal
JOURNAL OF NERVOUS AND MENTAL DISEASE
Volume 200, Issue 3, Pages 243-247Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/NMD.0b013e318247d275
Keywords
Randomized clinical trial; institutional rearing; orphaned and vulnerable children
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Funding
- NIMH NIH HHS [R01 MH091363] Funding Source: Medline
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The Bucharest Early Intervention Project is the first ever randomized controlled trial of foster care as an alternative to institutional care for young abandoned children. This article examines ethical issues in the conceptualization and implementation of the study, which involved American investigators conducting research in another country, as well as vulnerable participants. We organize the discussion of ethical questions about the study around several key issues. These include the nature and location of the vulnerable study population, the social value of conducting the study, the risks and benefits to participants of participating in the study, and posttrial obligations of the investigators. In discussing how these questions were addressed as the study was designed and after it was initiated, we describe our attempts to wed sound scientific practices with meaningful ethical protections for participants.
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