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Ethical Conduct of Clinical Research Involving Children
treatment also forbid the health care provider from billing the parent, lest confidentiality be breached. A number of states have general consent statutes that permit minors to consent to medical or surgical treatment at a specified age; usually it is age 16 years but in some states it is as young as 14 years. Furthermore, the jurisprudence in many other states has accepted the “mature minor” rule, in which a minor who is subjectively assessed as capable of giving the same degree of informed consent as an adult may be treated without a parent’s involvement. In some states, minors who are parents may be in the paradoxical position of being able to permit treatment on behalf of their child but not on their own behalf.
Again, as Appendix B explains, statutes and case law rarely refer specifically to decisions by minors about participation in research. Because state laws are so variable and often vague, investigators and IRBs must be knowledgeable about federal, state, and local laws related to consent, confidentiality, and related matters when they consider research that involves waiver of parental permission. Differences among state policies could complicate certain studies involving sites in more than one state and might preclude the inclusion of certain sites. In addition to seeking legal counsel, investigators and IRBs may find it prudent to consult representatives from communities that might be affected by the proposed research and to consider the climate in the state regarding parental prerogatives. As emphasized earlier, federal regulations require that appropriate protective procedures be in place if parental permission for research participation is to be waived.
Wards of the State
Responding in part to some of the abuses and controversies described in Chapter 1, federal regulations impose special conditions for research participation by children who are wards of the state. Although the DHHS regulations do not define the term ward, the interim regulations issued by FDA define a ward as “a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable, Federal, State, or local law” (21 CFR 50.3(q)). When the state assumes the role of parent for these children, it may still defer to the child’s biological parent(s) if the custody is temporary.
For research that involves more than minimal risk and that does not hold the prospect of direct benefit to the child participant, IRBs can approve research involving a ward of the state only under specific circumstances. These are when the proposed study (1) is related to the child’s status as a ward or (2) is conducted in settings such as schools or hospitals where the majority of children participating in the study are not wards. When such research is approved, each child must have an independent,