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Protecting Data Privacy in Health Services Research
in light of how the PHI of minors is commonly treated in health services research. In brief summary, these include the following issues:
Children constitute a heterogeneous population. Within the broad population of legally defined “minors,” research studies document considerable variability in developing judgment, self-understanding, and psychosocial functioning. This means that:
the capacities of children and youth to assent to the uses of their PHI and to meaningfully understand assurances concerning confidentiality, privacy, and research risk develop considerably with increasing age, with adultlike capabilities evident early in adolescence;
the psychological risks posed by the inappropriate disclosure of minors' PHI (e.g., perceived privacy violations, feelings of embarrassment or humiliation, threats to their medical or legal interests) change complexly with development but, by late childhood, approximate the risks experienced by adults;
collected PHI, older children and adolescents may be concerned about access to health data collected when they were younger and have a strong interest in giving independent consent to its use.
These considerations are relevant to all minors, especially to adolescent populations who can in some jurisdictions consent independently of their parents to certain forms of medical treatment (e.g., substance abuse or mental health treatment).
Children constitute a uniquely vulnerable population because of their limited rights under the law and their limited capacities for autonomous decision making. This means that special provisions are needed to ensure their protection from research risks, which include, but extend beyond, parental proxy consent on their behalf.
Problems in proxy consent arise from (1) fundamental difficulties in distinguishing the interests of children from those of their parents or other custodians, (2) the fact that consent also involves accepting provisions for control over research materials, knowledge of research findings, and conditions governing children's elective withdrawal from research participation in which parents' and children's interests may also differ, and (3) lack of clarity about whether proxy consent endures for the entire course of the research investigation, including longitudinal or secondary analyses, regardless of children's developing capacities (and interests) in asserting and protecting their own rights as research participants as they mature.
Special considerations in biomedical data result from the uniquely sensitive nature of such data, and the potential immediate and longer-term implications of PHI for children in the context of family dynamics. These require im-