What Conditions Justify Risky Nontherapeutic or “No Benefit” Pediatric Studies: A Sliding Scale Analysis

Abstract

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science (CIOMS), and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions (See Table 1). Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved.