competent appointed advocate (in addition to any other appointed guardian). If a minor is under detention by the state, the provisions of Subpart C of the DHHS regulations, which govern research involving prisoners, may also apply.

As discussed in Appendix B, state policies on research participation by wards of the state rarely appear to be codified in statute or clear case law. Rather, state agencies responsible for these children often appear to have little formal, written guidance for making decisions. As a consequence, investigators likewise may have little guidance beyond the federal regulations. Some states appear to be much more restrictive than others in permitting wards to be included in research and may thereby discourage research that might increase understanding of this population of vulnerable children.


It’s a lot easier to make a decision for yourself rather than for somebody else … you just don’t know if you’ve done the right thing.

Parent (quoted in Caldwell et al., 2003, p. 557)

The literature on adults’ understanding of and decisions about their own participation in research is considerably more extensive than the corresponding literature on parents making decisions about their child’s participation in research. The committee believes that findings about the reasoning that adults use and the decisions that adults make on their own behalf are generally relevant to an understanding of decisions that adults make on behalf of children. It recognizes, however, that the anxieties associated with making decisions on behalf of one’s child, especially one’s sick child, may put particular stress on an adult’s comprehension, reasoning, and decisionmaking capacities (Ruccione et al., 1991; Levi et al., 2000; McGrath, 2002). Some research findings about informed consent for clinical care are also relevant to the research context, although the ethical and informational requirements are usually more stringent for informed consent in the context of research.

What should parents be able to understand to make an informed decision about their child’s participation in research? In general, parents of prospective research participants should have a basic understanding of

  • the purposes of the research and what procedures (medical and otherwise) that the child will undergo (or may undergo, if random assignment to treatment and control groups is planned);

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