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Accountability in Research
Ethics, Integrity and Policy
Volume 22, 2015 - Issue 1
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Original Articles

Factors Influencing Parental Consent in a Hypothetical Pediatric Vaccine Trial in a Developing Country Setting: A Questionnaire Study

, M.D., , M.D. & , M.D.

REFERENCES

  • Caldwell, P. H. Y., Butow, P. N., and Craig, J. C. (2002). Pediatricians’ attitudes to randomized controlled trials involving children. J. Pediatr., 141:798–803.
  • Caldwell, P. H. Y., Murphy, S. B., Butow, P. N., and Craig, J. C. (2004). Clinical trials in children. Lancet, 364:803–811.
  • Declaration of Helsinki. (1964). N. Engl. J. Med., 271:473–474.
  • Durand-Zaleski, I. S., Alberti, C., Durieux, P., Duval, X., Gottot, S., Ravaud, P., Gainotti, S., Vincent-Genod, C., Moreau, D., and Amiel, P. (2008). Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception. J. Med. Ethics 34(e16):1–9.
  • Farquhar, C., John-Stewart, G. C., John, F. N., Kabura, M. N., and Kiarie, J. N. (2006). Pediatric HIV type 1 vaccine trial acceptability among mothers in Kenya. AIDS Res. Hum. Retroviruses 22:491–495.
  • Gangarosa, E. J., Galazka, A. M., Wolfe, C. R., Phillips, L. M., Gangarosa, R. E., Miller, E., and Chen, R. T. (1998). Impact of anti-vaccine movements on pertussis control: The untold story. Lancet, 351:356–361.
  • Harth, S. C. and Thong, Y. H. (1990). Socioeconomic and motivational characteristics of parents who volunteer their children for clinical research: A controlled study. BMJ, 300:1372–1375.
  • Harth, S. C., Johnstone, R. R., and Thong, Y. H. (1992). The psychological profile of parents who volunteer their children for clinical research: a controlled study. J. Med. Ethics, 18:86–93.
  • Jacobson, R. M, Ovsyannikova, I. G., and Poland, G. A. (2009). Testing vaccines in pediatric research subjects. Vaccine, 27:3291–3294.
  • Jaspan, H. B., Gray, G. E., Robinson, A. K., Coovadia, H. M., and Bekker, L. G. (2005). Scientific justification for the participation of children and adolescents in HIV-1 vaccine trials in South Africa. S. Afr. Med. J., 95:685–687.
  • Kaljee, L. M., Pham, V., Son, N. D., Hoa, N. T., Thiem, V. D., Canh do, G., Thoa le, T. K., Ali, M., Ochiai, R. L., Danovaro-Holliday, M. C., Acosta, C. J., Stanton, B., amd Clemens, J. (2007). Trial participation and vaccine desirability for Vi polysaccharide typhoid fever vaccine in Hue City, Viet Nam. Trop. Med. Int. Health, 12:25–36.
  • Masełbas, W. and Czarkowski, M. (2007). Social aspect of clinical research in Poland. Pol. Merkur Lekarski, 23:469–472.
  • McClure, C. A., Gray, G., Rybczyk, G. K., and Wright, P. F. (2004). Challenges to conducting HIV preventative vaccine trials with adolescents. J. Acquir. Immune Defic. Syndr. 36:726–733.
  • Shui, I. M., Weintraub, E. S., and Gust, D. A. (2006). Parents concerned about vaccine safety differences in race/ethnicity and attitudes. Am. J. Prev. Med., 3:244–251.
  • Sihlling, V. and Young, B. (2009). How do parents experience being asked to enter a child in a randomised controlled trial? BMC Medical Ethics, 10:1–11.
  • Smyth, R. L. and Weindling, A. M. (1999). Research in children: ethical and scientific aspects. Lancet, 354:2124.
  • Steinbrook, R. (2002). Testing medications in children. N. Engl. Med., 347:1462–1470.
  • Smailbegovic, M. S., Laing, G. J., and Bedford, H. (2003). Why do parents decide against immunization? The effect of health beliefs and health professionals. Child Care Health Dev., 29:303–311.
  • Tait, A. R., Voepel-Lewis, T., and Malviya, S. (2003). Do they understand? (Part 1) Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiol., 98:603–608.
  • TUİK (Medyan gelir grupları ve sahip olunan eşyaya göre nüfusun dağılımı. Gelir dağılımı ve yaşam koşulları istatistikleri). (2010). Available at http://www.tuik.gov.tr/PreTablo.do?alt_id=1011. Last accessed January 1, 2013.
  • U. S. Food and Drug Administration (FDA). (2013). Should Your Child Be in a Clinical Trial? Available at http://www.fda.gov/forconsumers/consumerupdates/ucm048699.htm. Last accessed July 7, 2013.
  • Wiley, F. M., Ruccione, K., Moore, I. M., McGuire-Cullen, P., Fergusson, J., Waskerwitz, M. J., Perin, G., Ge, J., and Sather, H. N. (1999). Parents’ perception of randomization in pediatric clinical trials. Cancer Pract., 7:248–256.
  • Yap, T. Y., Yamokoski, A. D., Hizlan, S., Zyzanski, S. J., Angiolillo, A. L., Rheingold, S. R., Baker, J. N., and Kodish, E. D. Phase I Informed Consent (POIC) Research Team. (2010). Phase I Informed Consent (POIC) Research Team. Informed consent for pediatric phase 1 cancer trials: Physicians’ perspectives. Cancer, 116:3244–3250.
  • Zupancic, J. A., Gillie, P., Streiner, D. L., Watts, J. L., and Schmidt, B. (1997). Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 99(E6):1–6.

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