. "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
otherwise regulated by 17 federal agencies . Additional protections (Subpart D of 45 CFR 46), which apply specifically to children, have been adopted by the U.S. Department of Health and Human Services , the Food and Drug Administration (FDA) (except for Section 46.408(c), which pertains to the waiver of parental permission), the U.S. Department of Education, the Central Intelligence Agency, and the Social Security Administration. Additional regulations issued by the U.S. Department of Education under the Protection of Pupil Rights Amendment govern social research conducted in school settings or otherwise related to education matters  (Table B.1; all tables are located in Addendum B1). The language of the federal regulations is frequently adopted as institutional review board (IRB) policy , with a likely result that most research, irrespective of the funding source, is reviewed—at least as an initial matter—according to the parameters of the federal guidelines.
Notably, with respect to several issues, the federal research regulations rely on state laws to provide relevant definitions or other elements essential to interpretation and application of the regulations. For example, the regulations define “children” as those persons who have “not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (emphasis added) . Similarly, “guardian” means “an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care” .
Thus, it is critical that researchers, IRB members, and others engaged in or affected by the research process understand how state laws might affect research with children and adolescents. Relevant inquiries include the following issues: age of majority, emancipation status, the “mature minor” rule and other specific provisions related to age of consent for general medical care, and/or specific conditions (e.g., substance abuse disorders or emotional disturbances).
An overview of state laws related to these issues follows. Also addressed are state laws, regulations, or policies specific to children in state custody (e.g., children in foster care or detention facilities), when such laws, regulations, or policies are available.1 These guidelines are of particular importance in that they apply to those children who likely have unique medical or psychosocial issues distinct from those of the general population
A separate project conducted under the auspices of the University of Rochester Medical Center is also pending. That project will survey IRBs at major academic medical centers in each state for further input as to state and local policies, guidance, etc., related to research with children and adolescents. Results from that study will be analyzed and published at a later date in a separate report.