Chapter

Pediatric Clinical Pharmacology

Volume 205 of the series Handbook of Experimental Pharmacology pp 219-244

Date:

Ethical Considerations in Conducting Pediatric Research

  • Michelle Roth-ClineAffiliated withU.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics
  • , Jason GersonAffiliated withU.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics
  • , Patricia BrightAffiliated withU.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics
  • , Catherine S. LeeAffiliated withU.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics
  • , Robert M. NelsonAffiliated withU.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics Email author 

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.

Keywords

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