In addition to the risks of daily life, the federal regulations provide a second standard for assessing minimal risk in research, specifically, the risks “ordinarily encountered … during the performance of routine physical or psychological examinations or tests.” Just as the committee concluded that the assessment of “risks of daily life” standard should be indexed to the experiences of normal, healthy, average children, it likewise concluded that the “routine examination” standard be interpreted with reference to the experiences of normal, healthy, average children. Ill children may routinely undergo much more burdensome and risky examinations. Again, assessments can appropriately take age into account because routine examinations differ for infants, children, and adolescents.
The components of “routine medical examinations” have no precise, universally accepted definition but what is sometimes called a well-child physician visit offers a reasonable basis for comparisons. In addition to a history, such a visit typically includes several routine, age-appropriate physical and psychological examinations or tests, guidance and education (for the child, the parents, or both), and immunizations.
Recommended elements of the physical examination component of a well-child visit are not entirely uniform (see, e.g., USPSTF, 1995; Schuster, 2000; and Behrman et al., 2004), in part because those making recommendations must often rely on clinical experience and judgment rather than solid scientific evidence about the potential benefits and risks of specific assessments or tests. Depending on the child’s age, the physical examination may include measurements of height, weight, and head circumference; assessment of obesity with skin-fold calipers (pincher-like devices used to determine levels of subcutaneous fat); collection of blood; measurement of heart rate and blood pressure; collection of voided urine; testing of fine and gross motor development; and hearing and vision tests. The recommended elements are most extensive for neonates and older infants and most limited for school-age, preadolescent children.
A central objective of the history component of a well-child visit is to identify health risks (e.g., poor diet or a lack of seat belt or car seat use). Because many health risks vary by age, so does the history component of an examination. For an adolescent’s routine medical examination, a full history includes exploration of sexual, smoking, and other behaviors that have health consequences.
Notwithstanding some disagreement about the specifics, the components of a well-child visit appear to be fairly modest in number and, taken individually, are reasonably well-characterized in content. They clearly include a far smaller set of activities than the activities of daily life. They also present a more limited range of risk of harm.