Informed consent, which provides the moral foundation for research involving human subjects, requires careful scientific and ethical analysis. Our research on informed consent aims to develop an empirically informed understanding of the consent process for pediatric cancer research that can be used to enhance informed decision making by parents and patients. The primary goal of our current project is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials. The long-term objective will be to improve care for children with refractory cancer and their families by developing a fuller understanding of the Phase I consent communication process, comprehension of parents and older children, and perspectives of clinician-investigators.
This research supported in part by:
The National Cancer Institute and National Institute for Child Health and Human Development
Joffe S, Fernandez CV, Pentz RD, Ungar DR, Mathew NA, Turner CW, Alessandri AJ, Woodman CL, Singer DA, Kodish E. Involving Children with Cancer in Decision-Making about Research Participation. J Pediatr 2006;149(6):862-8.
Kodish E, Noll R, Ruccione K, Lange B, Angiolillo A, Pentz R, Zyzanski S, Siminoff L, Drotar D. Communication of Randomization in Childhood Leukemia Trials. JAMA 2004; 291: 470-5.
Kodish, ED. Informed Consent for Pediatric Research: Is it Really Possible? J Pediatr 2003; 142: 89-90.
Yamokoski, A.D., Hazen, R.A., Kodish, E.D. (2008). “Anticipatory guidance to improve informed consent: A new application of the concept.” Journal of Pediatric Oncology Nursing 25 (1): 34-43.
Yap, T.Y., Yamokoski, A., Noll, R., Drotar, D., Zyzanski, S., and Kodish, E. (2009). “A physician-directed intervention: Teaching and measuring better informed consent.” Academic Medicine 84 (8): 1036-1042.
The Cleveland Clinic Research Team:
Eric Kodish, MD: Principal Investigator
Sabahat Hizlan, BA, BS: Data Manager
Angela Leek, BA: Research Assistant
For more information contact: