that the legislative intent behind consent to treatment—to promote individual and public health while preserving confidentiality—should similarly apply to research.

Moreover, it is important to note that where the law is silent on the issue (e.g., the applicability of treatment consent by minors to research consent), silence does not imply impermissibility. In fact, it could be argued that actions are permissible unless they are specifically restricted by the courts or legislative actions [31].

As a general principle, however, judicial development of the common law is not arrested by piece-meal legislative adoption of specific statutory exceptions to a general common law rule…. One of the great attributes of Anglo-American common law has been the flexibility demonstrated by the case by case judicial development of the principles and rules of the common law to adapt to the emerging conditions of society; this flexibility permits the law to remain relevant and reasonable, preventing “mindless obedience to [a] precept [that] can confound the search for truth and foster an attitude of contempt” [32].

Alternatively, of course, it should be noted that there is an important distinction between research and treatment. The former seeks to build generalizable knowledge without a focus on individual benefit, whereas the latter focuses on individual well-being. Accordingly, inasmuch as their intents vary, so too might the legal protections for children and adolescents attached to research versus treatment justifiably vary. Federal regulations also note that “assent,” the child’s “affirmative agreement to participate in research,” is required when IRBs determine that children are capable of such, thus leaving much to the IRB’s discretion [33]. This imprecision in federal regulations has not been addressed by the states [34].

Finally, it is also worth clarifying the distinction between emancipation and mature minor status, a distinction not always clearly made in state law.12 In general, emancipation (in this appendix) confers broader “adult” status to youth in all aspects of their lives, whereas the attainment of “mature minor” status is more narrowly construed in terms of the sort of health care consent authority that it confers. These differences might similarly affect the reach of regulations on research with minors, or at least the requirements to consent to research. “Emancipated minors,” to whose lives events have conferred—in the eyes of the state—legal adulthood, should be able to consent to research as adults.13 “Mature minors,” on the other

12  

See discussion infra, pp. 323–325.

13  

This still leaves the question, however, of how a researcher or IRB should reach the conclusion that a minor is emancipated. Arguably, at a minimum, minors who satisfy the common law criteria for emancipation or who have been emancipated by a court should be considered emancipated.



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