Protecting Data Privacy in Health Services Research (2000) / Chapter Skim
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Appendix C Protecting the Health Services Research Data of Minors
Appendix C Protecting the Health Services Research Data of Minors
Pages 159-172
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From page 159... ...
. However, when children are research participants, there may be more unique risks to the confidentiality and privacy of their PHI and special concerns in the secondary analysis of their health data.
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From page 160... ...
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)
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From page 161... ...
A number of questions are raised by this case illustration that are also relevant to the protection of health services research data by minors: · Given the sensitive nature of the secondary analyses (and potential perceptions of privacy invasion) , were the researchers ethically obligated to seek permis
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From page 162... ...
· Did the initial use of parental passive consent procedures rather than active consent, in which the parent must contact the researchers to consent volitionally after having been informed about the research purposes alter the ethical obligation to seek further consent after the research team began to investigate more sensitive issues? Or were original consent procedures adequate regardless of whether passive or active consent was used?
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From page 163... ...
For some risks, vulnerability increases. Moreover, children's vulnerability to the research risks most pertinent to adults increases sharply over time, these include perceived violations of privacy, the embarrassment and humiliation that may derive from inappropriate disclosure of personal health data, and some of the tangible consequences of unwarranted disclosure (e.g., difficult family processes or compromised medical or legal circumstances, see below)
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From page 164... ...
In addition, older children and adolescents, like young adults, are likely to feel much differently about the uses of data gathered when they were very young than they were capable of feeling at the time these data were initially obtained. Concerns over personal privacy, threats of embarrassment or humiliation, and more tangible concerns related to the potentially inappropriate disclosure of research data now become personal issues (whereas formerly they were addressed on behalf of the child through parental proxy consent procedures)
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From page 165... ...
, children should be capable of making their own, independent decisions concerning access to and the disposition of their research materials if they have developed sufficiently mature judgment to do so. Problems in Proxy Consent Just as there is value in recognizing that parents usually make thoughtful judgments concerning the research participation of their offspring, there is value also in recognizing the circumstances in which proxy consent does not necessarily protect children's interests.
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From page 166... ...
. Potential problems in proxy consent are even more apparent when consent is given not by a biological parent, but by a representative of a government agency when children are wards of the state (see National Bioethics Advisory Commission, 1998~.
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From page 167... ...
Moreover, when such blanket consent is requested at the time of medical treatment, these circumstances may make it very difficult to decline. Special Considerations in Biomedical Data The need for parental proxy consent and children's assent, the developmentally graded risks faced by children owing to the inappropriate disclosure of research data, and the growing capacities for personally informed consent that emerge as minors mature are considerations shared by behavioral and biomedical researchers who enlist children into their studies.
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From page 168... ...
These issues can be illustrated by considering the genetic testing of children and adolescents. With the recent significant advances in knowledge generated by the Human Genome Project, the challenges posed by the uses and potential misuses of personal genetic information have received increased attention.
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From page 169... ...
Furthermore, the interests that governed initial parental proxy consent to genetic testing may be much different from those governing the young adult's personal concerns about the dissemination of this information. This suggests that procedures governing the uses of PHI obtained from minors must be considered within a life-span context for the individual.
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From page 170... ...
· Do research procedures undergo a more searching examination when children are research participants, particularly with respect to assessing in a developmentally graded manner the potential risks of their research participation? IRBs assume a special responsibility to children as research participants and cannot assume that parental proxy consent will always safeguard children's interests.
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From page 171... ...
National Bioethics Advisory Commission (1999~. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance.
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From page 172... ...
. Behavioral research involving children: A developmental perspective on risk.
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