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A Retrospective Study of Children's Perceptions of Participation as Clinical Research Subjects in a Minimal Risk Study

 

作者: BRUCE FOGAS,   JESSICA OESTERHELD,   RICHARD SHADER,  

 

期刊: Journal of Developmental & Behavioral Pediatrics  (OVID Available online 2001)
卷期: Volume 22, issue 4  

页码: 211-216

 

ISSN:0196-206X

 

年代: 2001

 

出版商: OVID

 

关键词: children;research subjects;ADHD;informed assent;satisfaction

 

数据来源: OVID

 

摘要:

The purpose of the study was to evaluate children's perceptions of their participation as research subjects in a minimal risk research study (a methylphenidate population pharmacokinetic study conducted 8 months earlier). We identified 115 children of an original 189, aged 6 to 19 years, who were responding well to regular methylphenidate for attention-deficit hyperactivity disorder. By using a structured format, telephone interviewers unconnected to the original study questioned the children about what it had been like to be a subject in terms of voluntariness, accuracy of informed consent, reasons for participating, and satisfaction with their experience. Children overwhelmingly perceived their involvement as voluntary (89%) and the information about the study as accurately presented (80%), and they reported a high level of satisfaction with their participation (97%). Self-interest was the most frequently reported reason for participation (47%). In a subsample of 25 children, the percentage of agreement of a 1-week test-retest equaled or exceeded 72% for all answers.

 



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