TY - JOUR
T1 - Participation in biomedical research
T2 - The consent process as viewed by children, adolescents, young adults, and physicians
AU - Susman, Elizabeth J.
AU - Dorn, Lorah D.
AU - Fletcher, John C.
N1 - Funding Information:
Children's participation in biomedical and behavioral research presents ethical dilemmas for researchers as well as for the parents who provide legal permission for their children to participate. Only recently have studies begun to examine children's understanding of human experimentation, 1,2 their capacity to consent, 3 and developmental differences in their capacity to consent to research participation.4, 5 In the situations examined, children can partic- Supported in part (L.D.D.) by a National Research Service Award (SRC-5-F31-NR05965) from the National Center for Nursing Research, National Institutes of Health. Submitted for publication Feb. 26, 1992; accepted May 20, 1992. Reprint requests: Elizabeth J. Susman, PhD, E-314 Health and Human Development Bldg., Pennsylvania State University, University Park, PA 16802. *Now at the University of Virginia School of Medicine, Charlottesville. 9/20/39511 ipate in some aspects of the consent process. To our knowledge, no empiric studies have examined the consent process for children who participate in biomedical research.
PY - 1992/10
Y1 - 1992/10
N2 - We examined the capacity of children, adolescents, and young adults to assent and consent to participation in biomedical research, and what physician-investigators believe is important for patients in these age groups to know about such participation. The sample included 44 male and female subjects, ranging in age from 7 to 20 years, who were hospitalized to treat elther pediatric cancer or obesity. The participants completed a structured interview that assessed knowledge of research participation using the elements outlined in the federal guidelines for informed consent. The study subjects were most knowledgeable about those elements of consent that assessed concrete information (e.g., freedom to ask questions, time elements involved, and the benefits of participation). They were less knowledgeable about those elements of informed consent that assessed abstract information (e.g., scientific vs therapeutic purpose of the study, and alternative treatments). Chronologic age was not related to knowledge of the elements of informed consent. The strategies that the study subjects used to reason about participation in research appeared to parallel their reasoning about other physical phenomena.
AB - We examined the capacity of children, adolescents, and young adults to assent and consent to participation in biomedical research, and what physician-investigators believe is important for patients in these age groups to know about such participation. The sample included 44 male and female subjects, ranging in age from 7 to 20 years, who were hospitalized to treat elther pediatric cancer or obesity. The participants completed a structured interview that assessed knowledge of research participation using the elements outlined in the federal guidelines for informed consent. The study subjects were most knowledgeable about those elements of consent that assessed concrete information (e.g., freedom to ask questions, time elements involved, and the benefits of participation). They were less knowledgeable about those elements of informed consent that assessed abstract information (e.g., scientific vs therapeutic purpose of the study, and alternative treatments). Chronologic age was not related to knowledge of the elements of informed consent. The strategies that the study subjects used to reason about participation in research appeared to parallel their reasoning about other physical phenomena.
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U2 - 10.1016/S0022-3476(05)81142-4
DO - 10.1016/S0022-3476(05)81142-4
M3 - Article
C2 - 1403387
AN - SCOPUS:0026687003
SN - 0022-3476
VL - 121
SP - 547
EP - 552
JO - The Journal of Pediatrics
JF - The Journal of Pediatrics
IS - 4
ER -