Ethics of Research in Pediatric Emergency Medicine

Abstract

Clinical research in the pediatric emergency department (ED) has been rapidly growing in the past decade, and has resulted in some of the most important milestone studies in the pediatric medical literature. However, it presents a unique ethical goal and requires that additional challenges, such as the acute medical condition, fear and anxiety, unfamiliar physician(s), fatigue, and lack of time be addressed in addition to the standard ethical requirements. These may impair several fundamental elements of research, including the patient enrollment process, informed consent/assent, randomization, and others. Every possible attempt must be made to reduce or minimize the risks to which the children are exposed, and one must be cognizant of the special needs of children and their families in the ED. Nevertheless, we are also obliged to find ethical ways to include them in appropriate research endeavors that aim to improve treatments for conditions unique to the ED. This paper explores and overviews the most recent literature in order to characterize the nature of ethical challenges complicating clinical research in pediatric emergency medicine, and then suggests some ethically sound solutions such as deferred/waived consent, designated research staff, and alternative study designs. Finally, a few examples of prospective, blinded randomized trials involving drugs in pediatric emergency medicine are provided, with special emphasis on how the investigators are overcoming the obvious ethical challenges.

Ethical Challenges in Pediatrics from the Viewpoints of Iranian Pediatric Residents

“…Considering children's rights as research and educational subjects in the field of pediatrics, prevention of ethical challenges in this regard was another finding of the present research; findings of other studies have also confirmed this issue (31,32).…”

Recherche en pédiatrie (2) : le consentement en pratique

“…et d'une revue exhaustive des lois et textes réglementaires, régissant l'obtention du consentement en cas de recherche conduite sur un mineur. Certaines situations particulières telles que la conduite d'essais chez l'enfant en situation d'urgence [5], en néonatologie [6,7] ou pour l'inclusion d'enfants dans les protocoles de traitement de pathologie maligne [8,9] ne sont pas discutées ici.…”

Back to school: challenges and rewards of engaging young children in scientific research

“…While it may be relatively easy to recruit children with specific diseases while in hospital as they and their families have most to gain from targeted research, this potential advantage may be counteracted by practical problems, such as parental anxiety, the child being too ill to study or the need for an immediate intervention which precludes the ability to obtain prospective parental consent 7. In instances such as encountered in emergency medicine, use of deferred consent may be preferable.…”