Rethinking the Concept of Risk and Benefit for Research with Children

Abstract

    After World War II, several ethical principles and guidelines for protecting human subjects of research, such as the Nuremberg Code, Belmont Report, and Code of Federal Regulation Title 45 Part 46 (45CFR46), were established. Although these principles and guidelines note that vulnerable groups such as children need special protection, this has resulted in the exclusion of these groups from participating in clinical research. In parallel, pharmaceutical industries have been wary of investing in the development of pediatric drugs, given the limited size of the market relative to that of drugs targeting adults. Thus, data on the safety and efficacy of pediatric drugs remain insufficient, and the bulk of these drugs is used off-label. This has collectively led to the unstable footing of pediatric medicine in medical and healthcare systems. In order to improve the current state of pediatric medicine, more opportunities should be provided for children to participate in clinical research. To this end, D. Wendler has attempted to justify clinical research involving children by redefining “minimal risk” and benefits. In this paper, we explore the ethical validity and applicability of his arguments.