Participation in biomedical research: The consent process as viewed by children, adolescents, young adults, and physicians

Elizabeth J. Susman, Lorah D. Dorn, John C. Fletcher

Research output: Contribution to journalArticlepeer-review

118 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)547-552
Number of pages6
JournalThe Journal of Pediatrics
Volume121
Issue number4
DOIs
StatePublished - Jan 1 1992

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

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