Perceived discomfort levels in healthy children participating in vaccine research

Journal of Empirical Research on Human Research Ethics

Volumn 8, Issue 3, 2013, Pages 66-72

  Westra, Anna E ^a   Van Gils, Elske J M ^b   Aarts, Fenne ^a   Rodenburg, Gerwin D ^b   Veenhoven, Reinier H ^c   Hak, Eelko ^d   Scharloo, Margreet ^a   Sukhai, Ram N ^a   Wit, Jan M ^a   De Beaufort, Inez ^e   Sanders, Elisabeth A M ^b  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c Infection and Immunology   (Netherlands)

^d UNIVERSITY OF GRONINGEN   (Netherlands)

^e ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Children; Ethics; Research subjects; Review board; Risk assessment; Vaccines

Indexed keywords

EID: 84881512010     PISSN: 15562646     EISSN: 15562654     Source Type: Journal    
DOI: 10.1525/jer.2013.8.3.66     Document Type: Article

References (15)

1. Council of Europe. (1997). Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Oviedo: Author.
2. Davies, P. S., Collins, D. L., Gregory, J. R., & Clarke, P. C. (1996). Parents' and children's reactions to taking blood in a nutrition survey. Archives of Disease in Childhood, 75(4), 309-313.
3. European Parliament. (2001). Directive 2001/20/EC. Clinical trials directive. Official Journal of the European Union, L 121:34-44.
4. European Union. (2006). Regulation (EC) No. 1901/2006 on medicinal products for paediatric use. Official Journal of the European Union, L 378:1-19.
5. Fradet, C., McGrath, P. J., Kay, J., Adams, S., & Luke, B. (1990). A prospective survey of reactions to blood tests by children and adolescents. Pain, 40(1), 53-60.
6. Humphrey, G. B., Boon, C. M., Van den Linden van der Heuvel, G. F., & Van de Wiel, H. B. (1992). The occurrence of high-levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics, 90(1), 87-91.
7. Institute of Medicine. (2004). Ethical conduct of clinical research involving children. Washington, DC: National Academy Press.
8. Jacobson, R. M., Swan, A., Adegbenro, A., Ludington, S. L., Wollan, P. C., & Poland, G. A. (2001). Making vaccines more acceptable: Methods to prevent and minimize pain and other common adverse events associated with vaccines. Vaccine, 19(17-19), 2418-2427.
9. O'Brien, K. L., & Nohynek, H. (2003). Report from a WHO Working Group: Standard method for detecting upper respiratory carriage of Streptococcus pneumoniae. Pediatric Infectious Disease Journal, 22(2), e1-e11.
10. U.S. Department of Health and Human Services. (1991). Basic HHS policy for protection of human research subjects. 45 CFR Part 46, Subpart A. Federal Register 56 (18 June 1991) p. 28012.
11. U.S. Department of Health and Human Services. (1983). Additional protections for children involved as subjects in research. 45 CFR Part 46, Subpart D. Federal Register 48 (8 March 1983) p. 9818.
12. U.S. Food and Drug Administration. (2002). Best Pharmaceuticals for Children Act. U.S. Public Law 107-109. Retrieved from http://www.fda.gov/ downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049874.pdf
13. U.S. Food and Drug Administration. (2003). Pediatric Research Equity Act. U.S. Public Law 108-146. Retreived from http://www.fda.gov/downloads/Drugs/ DevelopmentApproval Process/DevelopmentResources/UCM077853.pdf
14. Van Gils, E. J., Veenhoven, R. H., Hak, E., Rodenburg, G. D., Bogaert, D., IJzerman, E. P., et al. (2009). Effect of reduced-dose schedules with 7-valent pneumococcal conjugate vaccine on nasopharyngeal pneumococcal carriage in children: A randomized controlled trial. JAMA, 302(2), 159-167.
15. World Medical Association. (2008). Declaration of Helsinki: Ethical principles for medical research involving human subjects (6th rev.). Seoul: World Medical Association.