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The relevant definition of a "child" is that of the country
in which research takes place. In the United States the age of majority
is based on state law. In North Carolina minors are defined as residents
under eighteen years of age, unless emancipated by court order or marriage.
In addition to the basic protections for research subjects, federal regulations
provide additional protections for children. These protections define
levels of risk children may experience and corresponding consent requirements.
For example, research of no more than minimal risk requires the consent
of only one parent. When research carries more than minimal risk and no
benefit to the individual child subject, consent of both parents is required.
The subpart also limits the use of exemptions
with research with children, although there are no restrictions on the
use of expedited review.
The basic model is that parents provide permission for their children
to become research subjects and children provide their assent to participate.
Assent must be tailored to the emotional and cognitive maturity of the
children. Note that the absence of dissent does not constitute assent.
Parental permission may not override child dissent unless the health of
the child is at stake.
The federal regulations do not describe the assent process as they do
the consent/parental permission process. Thus it is up to researchers
to design a process consistent with the decision making skills of their
prospective subjects. The ethnic background, nationality, educational
level, and socioeconomic status of the families and children must be taken
into account when designing the parental permission and child assent processes.
Parental permission and child assent may be waived in accordance with
the criteria set forth
in the federal regulations. Parental permission may also be waived when
it is not a reasonable requirement to protect subjects, e.g. when children
are neglected or abused.
Duke investigators who plan to do research with children as subjects are
required to take the tutorial, Research Involving Children, available
in July of 2003. Completing the tutorial will satisfy part of the continuing
education requirement for investigators.
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