Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial

References

• Appelbaum, P. S., Roth, L. H., & Lidz, C. W. (1982). The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry, 5, 319–329. doi:10.1016/0160-2527(82)90026-7
   PubMed Web of Science ®Google Scholar
• Appelbaum, P. S., Roth, L. H., Lidz, C. W., Benson, P., & Winslade, W. (1987). False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report, 17(2), 20–24. doi:10.2307/3562038
   PubMed Web of Science ®Google Scholar
• Blake, D. R., Lemay, C. A., Kearney, M. H., & Mazor, K. M. (2011). Adolescents’ understanding of research concepts: A focus group study. Archives of Pediatrics and Adolescent Medicine, 165, 533–539. doi:10.1001/archpediatrics.2011.87
   PubMed Web of Science ®Google Scholar
• Borzekowski, D. L. G., McCarthy, C., & Rosenfeld, W. D. (2012). Ten years of TeenHealthFX.com: A case study of an adolescent health web site. Pediatric Clinics of North America, 59, 717–727. doi:10.1016/j.pcl.2012.03.018
   PubMed Web of Science ®Google Scholar
• Coletti, A. S., Heagerty, P., Sheon, A., Gross, M., Koblin, B. A., Metzger, D., & Seage III, G. R. (2003). Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials. Journal of Acquired Immune Deficiency Syndrome, 32, 161–169. doi:10.1097/00126334-200302010-00008
   PubMed Web of Science ®Google Scholar
• Cotton, K. (1991). Close up #10: Computer-assisted instruction school improvement research series: Northwest Regional Educational Laboratory. Retrieved from http://educationnorthwest.org/resource/825
   Google Scholar
• DeBell, M., & Chapman, C. (2003). Computer and internet use by children and adolescents in 2001. Washington, DC: US Department of Education, National Center for Education Statistics.
   Google Scholar
• Fabio, R. A., & Antonietti, A. (2012). Effects of hypermedia instruction on declarative, conditional and procedural knowledge in ADHD students. Research in Developmental Disabilities, 33, 2028–2039. doi:10.1016/j.ridd.2012.04.018
   PubMed Web of Science ®Google Scholar
• Flory, J., & Emanuel, E. (2004). Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA, 292, 1593–1601. doi:10.1001/jama.292.13.1593
   PubMed Web of Science ®Google Scholar
• Hosek, S. G., & Zimet, G. D. (2012). Behavioral considerations for engaging youth in HIV clinical research. Journal of Acquired Immune Deficiency Syndromes, 54, S25–S30. doi:10.1097/QAI.0b013e3181e15c22
   Google Scholar
• Howard, J. M., & DeMets, D. (1981). How informed is informed consent: The BHAT experience. Controlled Clinical Trials, 2, 287–303. doi:10.1016/0197-2456(81)90019-2
   PubMedGoogle Scholar
• Huang, J. S., Terrones, L., Tompane, T., Dillon, L., Pian, M., Gottschalk, M., … Bartholomew, L. K. (2014). Preparing adolescents with chronic disease for transition to adult care: A technology program. Pediatrics, 133, e1639–e1646. doi:10.1542/peds.2013-2830
   PubMed Web of Science ®Google Scholar
• Joffe, S., Cook, E. F., Cleary, P. D., Clark, J. W., & Weeks, J. C. (2001). Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet, 358, 1772–1777. doi:10.1016/S0140-6736(01)06805-2
   PubMed Web of Science ®Google Scholar
• Koblin, B. A., Heagerty, P., Sheon, A., Buchbinder, S., Celum, C., Douglas, J. M., … Seage, G. (1998). Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States. AIDS, 12, 785–793. doi:10.c7/00002030-199807000-00015
   PubMed Web of Science ®Google Scholar
• Lewis, C. E., Lewis, M. A., & Ifekwunigue, M. (1978). Informed consent by children and participation in an influenza vaccine trial. American Journal of Public Health, 68, 1079–1082. doi:10.2105/AJPH.68.11.1079
   PubMed Web of Science ®Google Scholar
• Lidz, C. W., & Appelbaum, P. S. (2002). The therapeutic misconception: problems and solutions. Medical Care, 40(9), V55–V63. doi:10.1097/00005650-200209001-00008
   Google Scholar
• Murphy, D. A., Hoffman, D., Seage, G. R., Belzer, M., Xu, J., Durako, S. J., … The Adolescent Trials Network for HIV/AIDS Interventions. (2007). Improving comprehension for HIV vaccine trial information among adolescents at risk for HIV. AIDS Care, 19(1), 42–51. doi:10.1080/09540120600680882
   PubMed Web of Science ®Google Scholar
• Nelson, R., & Amdur, R. J.. (2007). Research involving children. In R. J. Ambdur & E. A. Bankert (Eds.), Institutional review board: Member handbook (2nd ed., pp. 187–193). Boston, MA: Jones and Bartlett.
   Google Scholar
• Nelson, R. M., Lewis, L. L., Struble, K., & Wood, S. F. (2010). Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention research. Journal of Acquired Immune Deficiency Syndromes, 54, S18–S24. doi:10.1097/QAI.0b013e3181e2012e
   PubMed Web of Science ®Google Scholar
• O’Lonergan, T. A., & Forster-Harwood, J. E. (2011). Novel approach to parental permission and child assent for research: Improving comprehension. Pediatrics, 127, 917–924. doi:10.1542/peds.2010-3283
   PubMed Web of Science ®Google Scholar
• Ott, M. A., Alexander, A. B., Lally, M., Steever, J. B., Zimet, G. D., & The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions. (2013). Preventive misconception and adolescents' knowledge about HIV vaccine trials. Journal of Medical Ethics, 39, 765–771. doi:10.1136/medethics-2012-100821
   PubMed Web of Science ®Google Scholar
• Petersen, A. C., & Leffert, N. (1995). Developmental issues influencing guidelines for adolescent health research: A review. Journal of Adolescent Health, 17, 298–305. doi:10.1016/1054-139X(95)00184-T
   PubMed Web of Science ®Google Scholar
• Pew Internet, & American Life Project. (2009). Generations online in 2009. Retrieved from http://www.pewinternet.org/2009/01/28/generations-online-in-2009/
   Google Scholar
• Santelli, J. S., Rogers, A. S., Rosenfeld, W. D., DuRant, R. H., Dubler, N., Morreale, M., … Schissel, A. (2003). Guidelines for adolescent health research: A position paper of the society for adolescent medicine. Journal of Adolescent Health, 33, 396–409.
   PubMedGoogle Scholar
• Siminoff, L. A. (2003). Toward improving the informed consent process in research with humans. IRB: Ethics & Human Research, 25(Suppl. 5), S1–S3.
   Google Scholar
• Simon, A. E., Wu, A. W., Lavori, P. W., & Sugarman, J. (2007). Preventive misconception: Its nature, presence, and ethical implications for research. American Journal of Preventive Medicine, 32, 370–374. doi:10.1016/j.amepre.2007.01.007
   PubMed Web of Science ®Google Scholar
• Susman, E. J., Dorn, L. D., & Fletcher, J. C. (1992). Participation in biomedical research: The consent process as viewed by children, adolescents, young adults, and physicians. The Journal of Pediatrics, 121, 547–552. doi:10.1016/S0022-3476(05)81142-4
   PubMed Web of Science ®Google Scholar
• Weithorn, L. A., & Campbell, S. B. (1982). The competency of children and adolescents to make informed treatment decisions. Child Development, 53, 1589–1598.
   PubMed Web of Science ®Google Scholar