Ethics for the Pediatrician: Pediatric Research Ethics: Evolving Principles and Practices

Abstract

1. Renee D. Boss, MD, MHS* 1. *Assistant Professor, Division of Neonatology, Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Md. Evidence-based medicine requires a foundation of excellent research. Yet, research in infants and children inherently poses potential risks to these vulnerable populations. The academic pediatrician may experience an ethical conflict in his or her dual roles as a clinician, with a primary interest in benefiting the individual child, and as a researcher, with an interest in advancing science and benefiting society. Understanding the evolution of ethical principles for pediatric research permits insight into current principles and the challenges of putting such principles into practice. This information is critical for both the pediatrician designing human research protocols and the pediatrician whose patients are enrolled in those protocols. Although documented cases of research involving pediatric subjects date 2 and 3 centuries in the past, systematic examination and regulation of human research began in the early 1900s. Initially, this oversight occurred in just a few nations. As the ethical principles of human research became more widely recognized over time, accountability at the national or international level historically has been uncertain. The ethical principles of consent and noncoercion were among the first to be applied to human research. In their earliest manifestations, these principles resulted in the exclusion of children from medical research. In 1900, the Prussian Ministry of Religious, Educational, and Medical Affairs prohibited research involving subjects who were not fully competent to provide consent, including children. (1) Without legal binding power, it is unclear what impact the directive had on medical research at the time; research involving children likely continued. In 1931, the Reich government refined distinctions between therapeutic and nontherapeutic research and continued to exclude children from both. Although German principles of human …