Rethinking Pediatric Assent: From Requirement to Ideal
Physician-investigators are required to obtain informed consent from adult participants in their studies. Inclusion of children in research legally requires informed permission of a child’s parent or guardian. It is increasingly recognized that a child need not assume a passive role when included in research, but that his or her active involvement should be sought, as expressed by the child’s assent to partake in clinical research. This article briefly explores the history of assent and the central role of assessing a child’s understanding of research and preference for participating in decisions related to their care, as necessary components of meaningful assent.
aDivision of Hematology/Oncology, Center for Cancer and Blood Disorders, Children's National Medical Center, 111 Michigan Avenue NW, Washington, DC 20010-2970, USA
bBerman Bioethics Institute, Johns Hopkins University, Hampton House 348, 624 N. Broadway, Baltimore, MD 21205, USA
cDepartment of Medicine, Georgetown University, 3800 Reservoir Road NW, Washington, DC 20007, USA
dDepartment of Oncology, Georgetown University, Research Building, Suite E501, 3970 Reservoir Road NW, Washington, DC 20007, USA
eDepartment of Pediatrics, Georgetown University, 3800 Reservoir Road NW, 2PHC, Washington, DC 20007, USA
fDepartment of Pediatrics, George Washington University, 2300 Eye Street NW, Suite 713W, Washington, DC 20037, USA
gDepartment of Immunology, George Washington University, 2300 Eye Street NW, Suite 713W, Washington, DC 20037, USA
hInstitutional Review Board, Children's National Medical Center, 111 Michigan Avenue NW, Washington, DC 20010-2970, USA
Corresponding author. Center for Cancer and Blood Disorders, Division of Hematology/Oncology, Children's National Medical Center, 111 Michigan Avenue NW, Washington, DC 20010-2970.
ABSTRACT