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Ethical Conduct of Clinical Research Involving Children
United States). The definitions of child in federal regulations on human research protections are cast in legal terms and do not cite an age or age range.3
In guidance encouraging testing of drugs in studies involving children for the purpose of establishing safe dosing levels, the FDA categorizes those ages 2 to 11 years (“up to 12 years”) as children (FDA, 1994a; 21 CFR 201.57(f)(9)(i)). The ICH guidelines cited above also use this age range. The guidelines stress the importance of investigating effects of medications on growth and development in this age group. The Nelson Textbook of Pediatrics uses a slightly broader age range—ages 2 to 12 years—and distinguishes early childhood (ages 2 to 5 years) and middle childhood (ages 6 to 12 years) (Behrman et al., 2004).
The National Institutes of Health (NIH) policy statement on the inclusion of children in research is expansive, defining a child as “an individual under the age of 21 years” for purposes of that policy (NIH, 1998a, unpaged).4 The policy does not differentiate among infants, older children, and adolescents and does not present a rationale for the age range selected. The policy does, however, require research proposals to describe the rationale for including or excluding particular age groups. The NIH statement notes that its policy applies notwithstanding the different age range used by FDA. It also notes that the definition differs from the regulations of the Department of Health and Human Services governing children’s participation in federally conducted, supported, or regulated research. Under NIH policy, an 18-year-old would be an adult for consent purposes (under state law) but a child for study inclusion purposes.
The term adolescent seems particularly variable in its definition, depending on the medical, public health, or psychosocial context in which it is used. NCHS observes that adolescence is “generally regarded as the period of life from puberty to maturity; [but] the meaning of ‘puberty’ and ‘maturity’ are often debated by health professionals” (NCHS, 2000, p. 19). Ado-
The regulations state that children are “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” (45 CFR 46.402(a); 21 CFR 50.3(o)). Chapter 5 and Appendix B discuss these regulations and state policies that allow adolescents, under certain circumstances, to make decisions about health care in their own right.
The policy statement was developed in response to language in House and Senate Appropriations Committee reports for fiscal year 1996 that noted the need for the more widespread inclusion of children in research (NIH, 1998a).