“Medical Benefit” and Therapeutic Misconception: The Ethical Conundrum of Phase 1 Pediatric Oncology Research

The Belmont Report, the backbone of human subjects protection in the US, begins by distinguishing practice from research: “It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other…”1 Although the latter aims at the well-being of individual patients with treatments whose benefit:risk has been endorsed by the US Food and Drug Admin istration, the former enlists participants in systematic investigations to determine empirically benefit:risk to develop generalizable knowledge and advance clinical medicine.
Source: The Journal of Pediatrics - Category: Pediatrics Authors: Tags: Editorials Source Type: research