. "Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." The Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press, 2004.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Ethical Conduct of Clinical Research Involving Children
Age of Consent Under Certain Circumstances
In addition, all states explicitly authorize minors to provide consent to health care when the decisions are related to certain disorders or types of care. That is, for purposes of consenting to specific health care services, these minors may be explicitly allowed—by statute—consent authority . It is important to note, however, that this does not mean that such minors cannot consent in other situations; rather, for public policy reasons, states have, at times, chosen to specifically address minors’ decisional capacity in certain situations to promote health-seeking behavior .11 Examples include consent for mental health treatment, substance abuse treatment, treatment for human immunodeficiency virus (HIV) infection or acquired immune deficiency sydrome (AIDS), testing or treatment for sexually transmitted diseases (STDs), and family planning services (Table B.5).
These conditions, in essence, allow individuals who are technically minors to make their own health care decisions under specific conditions. At issue, however, is the extent to which treatment-related consent, whether in general medical settings or for specific conditions, translates to the research setting.
Few states have any regulations that apply specifically to research with children and adolescents . Moreover, those statutes that address research with youth do so only under confined circumstances . Thus, although federal regulations reference state law, state law—as specifically applied in the research setting—is a relative vacuum in terms of the regulation of research with children and adolescents.
This uncertainty and frequent silence on the matter leaves researchers and IRBs in a position to make a best guess as to whether state laws related to treatment also apply to research, although there are good reasons to believe that they do apply, at least in certain situations . Arguments have been put forward that such laws should apply, at least to the extent that research relates to specific conditions for which consent to treatment laws apply, for example, mental health and STDs . For example, if a study sought to investigate the behavioral mechanisms at play in adolescents’ decisions to seek out treatment for an STD, a state that allows adolescents to consent to treatment for an STD should also allow for consent to research in connection with that STD. The argument might proceed
Again, this does not mean that other areas of consent are prohibited; instead, they exist in the “gray zone” of prudent (“reasonable”) responses to the facts of a given case.