Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

  title={Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration},
  author={John Rossi and Robert S. Nelson},
  journal={Accountability in Research},
  pages={407 - 432}
ABSTRACT Despite more than thirty years of debate, disagreement persists among research ethicists about the most appropriate way to interpret the U.S. regulations on pediatric research, specifically the categories of “minimal risk” and a “minor increase over minimal risk.” Focusing primarily on the definition of “minimal risk,” we argue in this article that the continued debate about the pediatric risk categories is at least partly because their conceptual status is seldom considered directly… 

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