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Ethics of Research in Pediatric Emergency Medicine

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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.

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Acknowledgments

G. Neuman, I. Shavit, D. Matsui, and G. Koren declare no relevant conflicts of interest. No sources of funding were used to support the writing of this manuscript.

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Authors and Affiliations

  1. Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, 555 University Ave., Toronto, ON, M5G1X8, Canada

    Gal Neuman & Gideon Koren

  2. Division of Pediatric Emergency Medicine, The Hospital for Sick Children, 555 University Ave., Toronto, ON, M5G1X8, Canada

    Gal Neuman

  3. Department of Pediatric Emergency Medicine, Meyer Children’s Hospital, Rambam Health Care Campus, Haifa, Israel

    Itay Shavit

  4. Children’s Health Research Institute, University of Western Ontario, London, ON, Canada

    Doreen Matsui

  5. University of Toronto, Toronto, ON, Canada

    Gideon Koren

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  1. Gal Neuman
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Correspondence to Gal Neuman.

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This article is part of the topical collection on Ethics of Pediatric Drug Research.

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Neuman, G., Shavit, I., Matsui, D. et al. Ethics of Research in Pediatric Emergency Medicine. Pediatr Drugs 17, 69–76 (2015). https://doi.org/10.1007/s40272-014-0110-4

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