CommentaryResearch Involving Wards of the State: Protecting Particularly Vulnerable Children
Section snippets
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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AIDS drugs tested on foster kids without advocate protection
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(2004)Drugs tested on HIV-positive foster children; Hill investigates ethical questions raised by 1990s trials in Md, elsewhere
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Belated charge ignites furor over AIDS drug trial
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Hearing on protecting foster children in clinical trials
- US Code of Federal Regulations. Title 45CFR46 Subpart D, §46.409. Department of Health and Human Services. Revised June...
- US Code of Federal Regulations. Title 2CFR50 Subpart D, §50.56. Department of Health and Human...
- US Code of Federal Regulations. Title 21 CFR 50...
Fostering health: health care for children and adolescents in foster care
(2005)
Data adapted from Child Welfare League of America national data analysis system
Hearing on protecting foster children in clinical trials
Cited by (11)
Care-planning and decision-making for youth with mental health needs in the foster care system
2018, Archives of Psychiatric NursingCitation Excerpt :All youth are considered highly vulnerable, in terms of their status as wards of the state. Wards of the state require extra protections when involved in research because they do not have traditional parent advocates and could be easily exploited (Varma & Wendler, 2008). Since vulnerability is present regardless of the age of participants, this was not a factor in selecting age range.
NO JUSTIFICATION TO EXCLUDE A STATE WARD FROM PEDIATRIC TRANSPLANT RESEARCH
2023, Challenging Cases in Clinical Research EthicsFUZZY LOGIC: HOW THE PRACTICALITIES OF STATE INVOLVEMENT SHAPE THE MOST ETHICALLY SUPPORTABLE WAY FORWARD
2023, Challenging Cases in Clinical Research EthicsPromoting Children's Rights and Protections in Program Evaluation
2023, American Journal of EvaluationFuzzy Logic: How the Practicalities of State Involvement Shape the Most Ethically Supportable Way Forward
2022, American Journal of BioethicsNo Justification to Exclude State Ward from Pediatric Transplant Research
2022, American Journal of Bioethics
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.