Parental consent to children’s participation in vaccine research has resulted in the licensure of essential vaccines. Recruitment to this type of research is typically difficult, however, and many parents decline. In this study, the authors interviewed parents about their decision for or against enrolling their child in a vaccine study. The data analysis suggests that parents’ ability to evaluate a vaccine study depends on how attuned they are with science and medicine, either professionally or as consumers of health services. Familiarity does not predispose parents to enrolling their child in research; rather, it is a predictor of parents’ confidence in their decision making. Many parents were motivated by altruism and trust, which, if uninformed, can leave the parents prone to exploitation. It is vital to ensure that parents are confident in their judgment of a study and its potential benefit to their child and society.
Autret, E., Duterte, J. P., Barbier, A. P., Jonville, P. F., & Berger, C. (1993). Parental opinions about biomedical research in children in Tours, France. Developmental Pharmacology & Therapeutics, 20, 64-71.
2.
Bellaby, P. (2003). Communication and miscommunication of risk: Understanding UK parents’ attitudes to combined MMR vaccination. BMJ, 327, 725-728.
3.
Black, N. (1994). Why we need qualitative research. Journal of Epidemiology and Community Health, 48, 425-426.
4.
Boyatzis, R. E. (1998). Transforming qualitative information: Thematic analysis and code development. London: Sage.
5.
Centers for Disease Control and Prevention. (2006). Recommended childhood and adolescent immunization schedule: United States, 2006. MMWR Morbidity & Mortality Weekly Report, 54(52), Q1-Q4.
6.
Clausen, J. A., Seidenfeld, M. A., Deasy, L. C., & Clausen, J. (1954). Parent attitudes toward participation in polio vaccine trials. American Journal of Public Health, 44, 1526-1536.
7.
Deasy L. C. (1956). Socio-economic status and participation in the poliomyelitis vaccine trial. American Sociological Review, 21(2), 185-191.
8.
Department of Health. (2006). Immunisation against infectious disease (“The Green Book”). London: TSO.
9.
Donovan, J., Mills, N., Smith, M., Brindle, L., Jacoby, A., Peters, T., et al. (2002). Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study—Commentary: Presenting unbiased information to patients can be difficult. BMJ, 325(7367), 766-770.
10.
Evans, M., Stoddart, H., Condon, L., Freeman, E., Grizzell, M., & Mullen, R. (2001). Parents’ perspectives on the MMR immunisation: A focus group study. British Journal of General Practice, 51, 904-910.
11.
Gellin, B. G., Malbach, E. W., & Marcuse, E. K. (2000). Do parents understand immunisations?: A national telephone survey. Pediatrics, 106, 1097-1102.
12.
Harth, S., & Thong, Y. H. (1990). Socio-demographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study. BMJ, 300, 1372-1375.
13.
Hayman, R. M, Taylor, B. J., Peart, N. S., Galland, B. C., & Sayers, R. M. (2001). Participation in research: Informed consent, motivation and influence. Journal of Paediatrics & Child Health, 37(1), 51-54.
14.
HMSO. (2004). The medicines for human use (clinical trials) regulations. Retrieved December 4, 2006, from http://www.opsi.gov.uk/si/si2004/20041031.htm
15.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1996). ICH harmonized tripartite guidelines, guidelines for good clinical practice. Retrieved December 4, 2006, from http://www.ich.org/LOB/media/MEDIA482.pdf
16.
Langley, J. M., Halperin, S. A., Mills, E. L., & Eastwood, B. (1998). Parental willingness to enter a child in a controlled vaccine trial. Clinical and Investigative Medicine, 21(1), 12-16.
17.
Langley, J. M., Halperin, S. A., & Smith, B. (2003). A pilot study to quantify parental anxiety associated with enrolment of an infant or toddler in a Phase III vaccine trial. Vaccine, 21, 363-3866.
18.
Madlon-Kay, D., & Harper, P. (1994). Too many shots?: Parent, nurse and physician attitudes toward multiple simultaneous childhood vaccinations. Archives of Family Medicine, 3, 610-616.
19.
Mason, B. W., & Donnelly, P. D. (2000). Impact of a local newspaper campaign on the uptake of the measles, mumps and rubella vaccine. Journal of Epidemiology & Community Health, 54, 473-474.
20.
Miller, E., Salisbury, D., & Ramsay, M. (2002). Planning, registration, and implementation of an immunisation campaign against meningococcal serogroup C disease in the UK: A success story. Vaccine, 20, S58-S67.
21.
Offit, P. A., Quarles, J., Gerber, M. A., Hackett, C. J., Marcuse, E. K., Kollman, T. R., et al. (2002). Addressing parents’ concerns: Do multiple vaccines overwhelm or weaken the infant’s immune system? Pediatrics109(1), 124-129.
22.
Ramsay, M. E., Yarwood, J., Lewis, D., Campbell, H., & White, J. (2002). Parental confidence in measles, mumps and rubella vaccine. British Journal of General Practice, 52, 912-916.
23.
Shoshana, T., Melman, S. T., Nguyen, T. T., Ehrlich, E., Schorr, M., & Anbar, R. D. (1999). Parental compliance with multiple immunization injections. Archives Pediatric Adolescent Medicine, 153, 1289-1291.
24.
Strauss, A., & Corbin, J. (1998). Basics of qualitative research. London: Sage.
25.
Tait, A. R., Voelpel-Lewis, T., & Malviya, S. (2003). Do they understand?: (Part 1) Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology, 98, 603-608.
26.
Tait, A. R., Voelpel-Lewis, T., & Malviya, S. (2004). Factors that influence parents’ assessments of the risks and benefits of research involving their children. Pediatrics, 113(4), 727-732.
27.
Tait, A. R., Voelpel-Lewis, T., Robinson, A., & Malviya, S. (2002). Priorities for disclosure of the elements of informed consent for research: A comparison between parents and investigators. Paediatric Anaesthesia, 12, 332-336.
28.
Tait, A. R., Voelpel-Lewis, T., Siewart, M., & Malviya, S. (1998). Factors that influence parent’s decisions to consent to their children’s participation in clinical anesthesia research. Anesthesia and Analgesia, 86(1), 50-53.
29.
World Medical Association. (1996). Declaration of Helsinki. Retrieved December 4, 2006, from http://www.wma.net/e/policy/b3.htm
30.
Yarwood, J., Noakes, K., Kennedy, D., Campbell, H., & Salisbury, D. (2005). Tracking mothers attitudes to childhood immunisation 1991-2001Vaccine, 23, 5670-5687.
