. "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.
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Ethical Conduct of Clinical Research Involving Children
Perhaps nothing will come of the recent court actions in New York and Maryland; in fact, as of this writing, the Maryland legislature declined to specifically address the facts of the Grimes case. Yet, as the impetus behind research with children and adolescents builds  and an increasingly vigilant and media-savvy subject advocate network grows , it seems likely that litigation could ensue. So, too, might litigation be prompted by new privacy regulations as applied in research settings . In consideration of such regulations, might it be wise for states to address this issue proactively to clarify the landscape out of an ethical sense of obligation, a legal sense of duty, and a pragmatic response to the growing media “buzz”? Additionally, might it also be wise for states to set forth guidance more uniformly and to learn from each other’s experiences, in recognition of the growing “multistate” nature of research? Such guidance could, for example, address more precisely what is meant by “emancipated minor” and “mature minor” on the one hand and “greater than minimal risk” and “nontherapeutic research” on the other .
It is likely that separate guidance would be needed for research with children and adolescents generally and research with children under state custody specifically, as the latter sit in unique circumstances in relation to the state’s protection and oversight of their care. Yet, whether the guidelines address one, two, or even three situations (e.g., a third situation applying to “sensitive” research, such as studies related to sexual promiscuity among adolescents), it is arguably better to provide clarifying guidance before the research endeavor with children develops a force of its own or breaks down in the face of a few unfortunate research endeavors or before research guidelines split between guidelines for government-funded research and guidelines for industry-funded research. The future of the state response is unclear. The future, however, likely includes more, not less, research with children and adolescents and, hence, will raise more research-related issues, concerns that states could begin to address now in a systematic and empirically testable fashion.
This review and analysis was funded by the Institute of Medicine. I wish to acknowledge the assistance of the Family Violence Clinic at the State University of New York at Buffalo School of Law, in particular, Shannon O’Keefe, clinic student, and Catherine Cerulli, faculty member. Thanks also to Abigail English and numerous child welfare representatives for sharing their ideas and resources. Finally, I owe a special thanks to Angela Roddey Holder for reviewing this paper and, most importantly, for her ongoing support and mentorship.