Testing vaccines in pediatric research subjects

Robert M. Jacobson, Inna G. Ovsyannikova, Gregory A. Poland

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Past difficulties encountered in pediatric vaccine research have positively influenced the development of modern regulations of human subjects' research. These regulations permit pediatric research but impose special restrictions on the types of studies to which children may participate, and these restrictions have important implications for modern vaccine trials. These ethical issues pose real but surmountable concerns. Considerations also include the use of placebos, critical for trial design but an impediment to parental permission. Recent pediatric vaccine studies illustrate practical alternatives to placebos that preserve allocation concealment and blinding yet obtain parental support. Vaccine researchers must consider the role parents play, not just in giving formal permission for their children's participation, but also for their roles in active recruitment, successful retention, and data acquisition. Studies of parents' attitudes do identify consistencies among motivating forces that drive parents to participate or refuse their children's participation. These studies should influence how we design and execute pediatric vaccine trials. Finally, ethical considerations and current regulations raise certain issues concerning the remuneration of the research volunteer when that volunteer is a child. The published literature illustrates wide variation in practice. Better understanding of the restrictions in pediatric research, the use of placebos, the attitude of parents, and the concerns with remuneration can better equip the vaccine researcher in pursuing successful studies in children.

Original languageEnglish (US)
Pages (from-to)3291-3294
Number of pages4
JournalVaccine
Volume27
Issue number25-26
DOIs
StatePublished - May 26 2009

Fingerprint

Research Subjects
Vaccines
Pediatrics
vaccines
Parents
wages and remuneration
Remuneration
placebos
Research
Placebos
testing
volunteers
Volunteers
researchers
Research Personnel
Ethics
preserves

Keywords

  • Child
  • Human experimentation
  • Vaccines

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)

Cite this

Jacobson, R. M., Ovsyannikova, I. G., & Poland, G. A. (2009). Testing vaccines in pediatric research subjects. Vaccine, 27(25-26), 3291-3294. https://doi.org/10.1016/j.vaccine.2009.02.031

Testing vaccines in pediatric research subjects. / Jacobson, Robert M.; Ovsyannikova, Inna G.; Poland, Gregory A.

In: Vaccine, Vol. 27, No. 25-26, 26.05.2009, p. 3291-3294.

Research output: Contribution to journalArticle

Jacobson, RM, Ovsyannikova, IG & Poland, GA 2009, 'Testing vaccines in pediatric research subjects', Vaccine, vol. 27, no. 25-26, pp. 3291-3294. https://doi.org/10.1016/j.vaccine.2009.02.031
Jacobson RM, Ovsyannikova IG, Poland GA. Testing vaccines in pediatric research subjects. Vaccine. 2009 May 26;27(25-26):3291-3294. https://doi.org/10.1016/j.vaccine.2009.02.031
Jacobson, Robert M. ; Ovsyannikova, Inna G. ; Poland, Gregory A. / Testing vaccines in pediatric research subjects. In: Vaccine. 2009 ; Vol. 27, No. 25-26. pp. 3291-3294.
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