Ethical considerations in conducting pediatric research

Michelle Roth-Cline, Jason Gerson, Patricia Bright, Catherine S. Lee, Robert M. Nelson

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children in clinical research. We propose a basic ethical framework to guide pediatric research, and suggest how this framework might be operationalized in linking science and ethics. Topics examined include: the status of children as a vulnerable population; the appropriate balance of risk and potential benefit in research; ethical considerations underlying study design, including clinical equipoise, placebo controls, and non-inferiority designs; the use of data monitoring committees; compensation; and parental permission and child assent to participate in research. We incorporate selected national (USA) and international guidelines, as well as regulatory approaches to pediatric studies that have been adopted in the USA, Canada, and Europe.

Original languageEnglish (US)
Title of host publicationHandbook of Experimental Pharmacology
Pages219-244
Number of pages26
Volume205
DOIs
StatePublished - 2011
Externally publishedYes

Publication series

NameHandbook of Experimental Pharmacology
Volume205
ISSN (Print)01712004
ISSN (Electronic)18650325

Fingerprint

Pediatrics
Research
Clinical Trials Data Monitoring Committees
Ethical Review
Vulnerable Populations
Biological Products
Ethics
Canada
Placebos
Acoustic waves
Guidelines
Monitoring
Pharmaceutical Preparations

Keywords

  • Child assent
  • Children
  • Choice of control group
  • Component analysis
  • Direct benefit
  • Equipoise
  • Ethics
  • Extrapolation
  • International guidelines
  • Minimal risk
  • Minor increase
  • Parental permission
  • Pediatrics
  • Placebo
  • Risk assessment
  • Scientific necessity
  • Subpart D

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Biochemistry

Cite this

Roth-Cline, M., Gerson, J., Bright, P., Lee, C. S., & Nelson, R. M. (2011). Ethical considerations in conducting pediatric research. In Handbook of Experimental Pharmacology (Vol. 205, pp. 219-244). (Handbook of Experimental Pharmacology; Vol. 205). https://doi.org/10.1007/978-3-642-20195-0_11

Ethical considerations in conducting pediatric research. / Roth-Cline, Michelle; Gerson, Jason; Bright, Patricia; Lee, Catherine S.; Nelson, Robert M.

Handbook of Experimental Pharmacology. Vol. 205 2011. p. 219-244 (Handbook of Experimental Pharmacology; Vol. 205).

Research output: Chapter in Book/Report/Conference proceedingChapter

Roth-Cline, M, Gerson, J, Bright, P, Lee, CS & Nelson, RM 2011, Ethical considerations in conducting pediatric research. in Handbook of Experimental Pharmacology. vol. 205, Handbook of Experimental Pharmacology, vol. 205, pp. 219-244. https://doi.org/10.1007/978-3-642-20195-0_11
Roth-Cline M, Gerson J, Bright P, Lee CS, Nelson RM. Ethical considerations in conducting pediatric research. In Handbook of Experimental Pharmacology. Vol. 205. 2011. p. 219-244. (Handbook of Experimental Pharmacology). https://doi.org/10.1007/978-3-642-20195-0_11
Roth-Cline, Michelle ; Gerson, Jason ; Bright, Patricia ; Lee, Catherine S. ; Nelson, Robert M. / Ethical considerations in conducting pediatric research. Handbook of Experimental Pharmacology. Vol. 205 2011. pp. 219-244 (Handbook of Experimental Pharmacology).
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