Upon the completion of this activity, learners will be able to:
Identify regulations pertaining to pediatric assent.
Discuss how regulations relate to ethics.
Provide case-based examples of assent for pediatric clinical trial studies.
References
45 CFR 46.408(a) (2010)
45 CFR 46.402(b) (2010)
Ann Emerg Med, 1995. 25(3): 317-320.
DHEW Publication #77-0004. Washington, DC, US Government Printing Office, 1977.
J Pediatric Pharmacol Ther, 2012. 17(3): p. 228-35.
Pediatrics, 2011. 127(5): p. 917-24.
Pt. Ed. And Coun., 2006. 61: 173-190.
Pt. Ed. and Coun. 2001. 43: 231-242.
Speaker(s): Leah Eisenberg, JD
Speaker bio
Leah Eisenberg is a clinical ethicist at University of Illinois Hospital. Her primary research interests relate to health literacy and improving patient understanding of medical and legal forms, including informed consent, assent, and HIPAA documents, recently through the use of comics. Another current research project involves the actual and perceived obligations of nurses towards pediatric patients in an active shooter event. She is co-editor of the Clinical Ethics case series in The American Journal of Bioethics. Another of her interests is graphic medicine. Prior to coming to UIC, she was Associate Professor of Medical Humanities and Bioethics at the University of Arkansas for Medical Sciences (UAMS). While there, she taught, served on two IRBs, directed the research ethics service, and was a clinical ethics consultant at both UAMS and Arkansas Children’s Hospital, the only children’s hospital in the state. Leah completed a fellowship in Bioethics Research at Mayo Clinic after earning a MA in Bioethics from Case Western Reserve University and a Juris Doctorate degree from the University of Wisconsin Law School.
