hand, are likely more limited in what they can and cannot consent to in treatment and in research.
Unfortunately, there is thus a great deal of uncertainty as to the extent of state regulations and the applicability of existing state regulations with respect to medical research with children and adolescents. Perhaps this should be unsurprising given the particularly recent nature of calls to enhance the base of research with populations of this age . Whatever the case, states have for the most part seen fit to follow federal regulations in this area to date . Whether the increasing demands for research with children and adolescents, coupled with advances in understanding of child and especially adolescent capacity and maturity, will affect states’ perceived need for further regulation remains to be seen. However, it would not be surprising if the conduct of more research in the absence of clear authority led to litigation, not unlike that witnessed in Maryland . Before the discussion turns to case law, however, it is also important to touch upon a certain subset of the child and adolescent population: children in state custody.
Of special concern to researchers and policy makers are regulations pertaining to children in state custody, for example, children in foster care, juvenile delinquents, and wards of the state. These children fall under state control under the doctrine of parens patriae, the concept that the states assume a “parental” role to protect children when biological parents are not able to do so, such as in instances of child neglect or abuse or when children enter the juvenile detention system.
As the primary “authority” figure for these children, the state therefore typically assumes a custodial role for children that may extend to health care decision-making. The federal child-specific regulations contain a section explicitly addressing research with “wards of the state” . Research with such children is permissible only if it relates to their status as wards or if it is conducted in settings in which a majority of the children involved as subjects are not wards . Examples of the former might include research specifically related to issues facing children in foster care subsequent to child abuse; the latter might pertain to school-based research in which wards of the state are in a minority.
The federal regulations further require that special advocates—not state-appointed guardians—be appointed for each child . These regulations are in addition to the more general federal regulations, which require IRBs to weigh the risks and benefits of any studies with any child populations, to ensure that IRBs do not allow high-risk (greater than a “minor increase over minimal risk”) studies unless they have a prospect of directly