Commentary
Research Involving Wards of the State: Protecting Particularly Vulnerable Children

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Background

US Food and Drug Administration regulations define wards of the state as children who are in the legal custody of the state.9 Typical reasons for children entering state custody include neglect, abandonment, or abuse by their biological parents.10 In some cases, the legal relationship between wards of the state and their biological parents is severed.10 In other cases, biological parents retain parental rights and stay involved in decisions affecting their children.10 Although most wards of the

Existing Regulations

Children in general are considered to be vulnerable research subjects. Federal regulations establish specific protections for research involving children and limits on the level of risk permitted. IRBs can approve pediatric research only in 3 risk-benefit categories: minimal risk (category 404), greater than minimal risk but with a prospect of direct benefit (category 405), and a minor increase over minimal risk without a prospect of direct benefit (category 406). Research that exceeds these

Proposal

Enrolling wards of the state in research raises 2 major concerns: the possibility that an unfair share of the burdens of research might fall on wards of the state, and the need to ensure that the interests of individual wards of the state are protected. These concerns are reflected in the special protections currently required for research in categories 406 and 407. However, these concerns are relevant to research in all risk-benefit categories, so having special protections only for some

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  • Cited by (11)

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    The opinions expressed are the authors’ own. They do not represent any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services. This work was completed as part of the authors’ official duties as employees of the NIH Clinical Center. The NIH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The authors have no financial conflicts of interest with respect to this manuscript or its contents.

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