TABLE 2.

Defining Prospect of Direct Benefit: Points of General Agreement Among Workshop Attendees

• Benefit relates to the health of the individual child enrolled in the study (eg, how the child feels, functions, or survives).

• Direct benefit arises directly from the research intervention being studied and accrues directly to the individual child enrolled in the study.

• The level of certainty required for determining that a prospect of benefit exists is not commensurate with the rigorous standards for confirming efficacy.

• The anticipated benefit needs to adequately justify the risks in the context of the child’s condition and alternative treatment options.