situations, investigators still have an obligation to discuss the expected or possible burdens that research participation may impose on the child, to offer their best assessment of the prospect of benefit, and to explain what relevant options for palliative care may be available within or outside the research setting.

Waiver of Parental Permission

As described earlier and consistent with the recommendation of the National Commission, DHHS regulations permit IRBs to waive parental or guardian permission for a child’s participation in research when such permission (1) is not a reasonable requirement to protect the child and (2) is not inconsistent with federal or state laws. The regulations also require the substitution of an appropriate protective mechanism when a parental waiver is approved. The FDA regulations do not allow such waivers, even when the research involves, for example, abused or neglected children who would thereby be denied the potential benefits of research participation.

For a variety of reasons, it is generally desirable to seek parental involvement in decisions about children’s and adolescents’ participation in research, especially when the research involves a clinical trial or presents more than minimal risk. In some situations, however, requiring parental permission could put a child or an adolescent at risk of violence, expulsion from the home, or other harm. This could impede some important research. For example, researchers trying to identify risk factors for HIV infection among different groups of adolescents might be successful in encouraging some teens to involve their parents but be unable to recruit those teens who are most fearful of violent parental reactions. Such reactions may be part of a family dynamic that is, itself, a risk factor.

In addition, some adolescents have no parents or guardians and are not wards of the state, and others are runaways or “throw-aways” (adolescents who are evicted from or asked to leave the home by their parents) (Blustein et al., 1999). Research to understand the circumstances of these adolescents—including their health status—is unlikely to be feasible if parental permission is required. Likewise, it may not be possible to enroll these adolescents in clinical studies that have the prospect of direct benefit.

In some cases, an adolescent for whom parental permission is not feasible may be able to receive an investigational product outside a trial if the product (e.g., an antidepressant) is approved for other uses or age groups. (Such use will still require either parental consent or a judgment that such consent is not required under applicable laws.) Although this approach may, on balance, be prudent and may potentially benefit the individual adolescent, it will not advance knowledge to benefit future adolescents.

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