Abstract
Specific regulations regarding oversight of research in children vary from country to country, but most share common principles derived from major consensus documents. Whereas the permissibility of research on adults depends heavily upon the informed consent of the subject, the regulation of research in pediatrics is focused primarily upon protection of the subjects from research risks. Since patients who require intensive care are commonly at high risk for complications related to the severity of their illnesses, justifying the risks of research on critically ill children may therefore be particularly challenging. Use of an approach known as “component analysis” can be very helpful in separating the risks attributable to the medical care itself from those that should be ascribed to the research. After identifying and isolating the research interventions, a three-step approach is helpful for evaluating the “net risks” of the research: (1) Separate each component of the research into discrete interventions. (2) Any intervention for which the benefits equal or exceed the risks is ethically justified. (3) For interventions in which the risks exceed the benefits, the “net risk” for each intervention needs to be justified, as follows: (a) the interventions may not exceed the locally defined threshold for pediatric research (e. g., not greater than a minor increment more than minimal risk, as in the U.S. regulations); and (b) the scientific value of the study for improving the care of future children must be sufficient to justify the sum of the net risks of the research interventions.
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References
Caldwell PH, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364:803–811
Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, van den Anker J (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. Br Med J 320:79–82
Council for International Organizations of Medical Sciences (CIOMS) (2007) International Ethical Guidelines for Biomedical Research Involving Human Subjects. http://www.cioms.ch/frame_guidelines_nov_2002.htm
World Medical Association (2004) Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/e/policy/b3.htm
Gill D (2004) Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 163:53–57
Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? J Am Med Assoc 283:2701–2711
Miller FG, Wertheimer A (2007) Facing up to paternalism in research ethics. Hastings Cent Rep 37:24–34
Committee on Bioethics, American Academy of Pediatrics (1995) Informed consent, parental permission, and assent in pediatric practice. Pediatrics 95:314–317
Protection of Human Subjects. Federal Register 1991; 45 CFR 46
Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17:20–24
Levy MD, Larcher V, Kurz R, CESP (2003) Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 162:629–633
Weijer C (2000) The ethical analysis of risk. J Law Med Ethics 28:344–361
Wendler D, Miller FG (2007) Assessing research risks systematically: the net risks test. J Med Ethics 33:481–486
Wendler D, Belsky L, Thompson KM, Emanuel EJ (2005) Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. J Am Med Assoc 294:826–832
Burck R (2002) Minimal risk: The debate goes on. Crit Care Med 30:1180–1181
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Truog, R.D. Ethical assessment of pediatric research protocols. Intensive Care Med 34, 198–202 (2008). https://doi.org/10.1007/s00134-007-0917-3
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DOI: https://doi.org/10.1007/s00134-007-0917-3