Participant Advocate, Research Involving Children

Parental Permission and Child Assent

Drawing on the ethical principle of respect for autonomy, investigators must follow federal regulations to obtain informed consent before any research procedures can begin. Consent must be obtained only from a participant who can give “legally effective” informed consent on his or her own behalf (DHHS, 2001, Section 46.116). Under federal guidelines, most children are defined as “persons who have not attained the legal age for consent to treatments or procedures involved in research” (DHHS, 2001, Section 46.402a). Exceptions are “mature” or “emancipated” minors who have been given legal authority via statute or case law to make autonomous decisions regarding certain medical treatments and procedures. To ensure adequate child protection, the child's parents or a guardian who has legal authority to consent on behalf of the child to general medical care must provide “permission” for the child's research participation. Following this approval, the child's “assent” must also be sought (DHHS, 2001, Section 46.408).

Why Are Participant Advocates Needed?

The rationale of obtaining permission from parents or guardians as a safeguard against harmful consequences to the child is based on the assumption that parents or guardians are present, caring, and motivated to act in the best interest of the child (Fisher, Hoagwood, & Jensen, 1996; Levine, 1986). Yet for some youth, this is not the case. For example, contacting the parents or guardians of a child who is abused or neglected may be detrimental to the child's welfare. In other cases, parents or guardians may be unknown, deceased, or unable to be contacted. In such situations, federal regulations allow parental consent to be waived, providing (a) the study procedures are of minimal risk and do not affect the rights and welfare of participants and (b) the research could not be carried out without the waiver (DHHS, 2001, Section 46.408c; Fisher et al., 1996). To obtain a waiver of permission from the parent, an “appropriate mechanism” for protecting the welfare and safety of the child involved in research must be put in place (DHHS, 2001, Section 46.408c). Unfortunately, there are no clear guidelines for what the “appropriate mechanism” should be; it is dependent on the nature and purpose of the research, risks and benefits of participation, and the age, maturity, status, and condition of the child. In most instances when the guardian's permission is waived, a participant advocate is appointed to ensure the protection of the participating child (Fisher et al., 1996). If the child is a ward of the state, federal regulations are more explicit and require a participant advocate be appointed for each child as an “appropriate mechanism” for protecting the child's welfare. This advocate must not be associated in any way with the research (except in the role of advocate or internal review board [IRB] member), the investigator, or the guardian organization (DHHS, 2001, Section 46.409b).

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