The presumption of benefit in clinical research with children and adolescents

Abstract

The concept of benefit is integral to the conduct of child and adolescent clinical research. When evaluating the ethical acceptability of research protocols, Institutional Review Boards (IRBs) must determine if benefits of the proposed study outweigh the risks and whether the research offers the prospect for direct benefit. This latter consideration is a particularly crucial determinant in situations where the child or adolescent wishes to dissent to research participation, since parents may legally overrule a dissenting child and compel their participation in research only when the IRB has concluded that the study offers the prospect for direct benefit [1]. Direct benefit refers to research where the purpose is to establish efficacy for an actual treatment for a disease, disorder or problem behavior [2]. King distinguishes other types of benefits that are ancillary to the primary purpose of the research, such as medical procedures or diagnostic tests, medical care, relationships with healthcare providers, positive feelings associated with altruistic behavior and financial compensation as ‘collateral benefits’ [2]. Future benefits to society are further classified as ‘aspirational’. However, a survey of IRB chairs responsible for reviewing research involving children revealed that direct and collateral benefits are often conflated. For example, the availability of psychological counseling unrelated to the research purpose was considered a direct benefit by 60% of the IRB Chair respondents and medical evaluations unrelated to the research purpose were thought to offer the prospect of direct benefit by 51% of the IRB Chairpersons sampled [3]. IRB Chair responses raise the concern that research involving children may be inappropriately perceived as offering direct benefit that, in turn, can curtail the autonomy of children and adolescents to dissent. Researchers and IRBs need a clear definition and conceptual understanding of research benefits, and how prospective research participants may be inclined to perceive them and be influenced by them.