Parental permission and adolescent assent and decision making in clinical resear

临床研究中的家长许可和青少年同意和决策

• 批准号: 9154095
• 负责人: Christine P Grady
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9154095
• 关键词: Adolescent; Authorization documentation; Benefits and Risks; Chronic Disease; Clinical; Clinical Research; Decision Making; Empirical Research; Enrollment; Ethics; Financial compensation; Health; Human; Interview; Journals; Manuscripts; Medical Research; Parents; Participant; Pediatric Research; Pediatrics; Process; Publishing; Questionnaires; Research; Research Ethics; Risk; Teenagers; Terminal Disease; Viola; Voice; experience; healthy volunteer; risk perception; willingness

This is an interview study of adolescents and their parents to better understand the processes of assent and parental permission for adolescents in research. The study involves face to face interviews with adolescents who represent the full spectrum of research participants from healthy volunteers to teens with chronic or terminal illnesses and one of their parents. Questionnaire domains include views regarding research, experience with the permission/assent process, decision making, and willingness to accept research risks. A total of 177 adolescent -parent pairs were interviewed. Four manuscripts have been published: 1. Wendler D, Abdoler E, Wiener L, Grady C. Views of adolescents and parents on pediatric research without the potential for clinical benefit. Pediatrics. 2012 Oct;130(4):692-9 2. Grady C, Wiener L, Abdoler E, Trauernicht E, Zadeh S, Diekema D, Wilfond B, Wendler D. Assent in Research: The Voices of Adolescents. Journal of Adolescent Health 2014, 54: 515-520 3. Wiener L, Viola A, Wilfond B, Wendler D, Grady C. Contrasting Views of Risk Perception and Influence of Financial Compensation Between Adolescent Research Participants and Their Parents. Journal of Empirical Research on Human Research Ethics, 2015. 10(1):49-58 4. Grady C, Nogues I, Wiener L, Wilfond B, Wendler D. Adolescent research participants descriptions of medical research. AJOB Empirical Ethics 2015.

这是一项针对青少年及其父母的访谈研究，旨在更好地了解青少年参与研究的同意和父母许可的过程。 这项研究涉及对青少年的面对面采访，这些青少年代表了所有研究参与者，从健康志愿者到患有慢性或绝症的青少年及其父母之一。调查问卷领域包括对研究的看法、许可/同意流程的经验、决策以及接受研究风险的意愿。 共有 177 对青少年与家长接受了采访。已发表四篇手稿： 1. Wendler D、Abdoler E、Wiener L、Grady C。青少年和家长对没有潜在临床益处的儿科研究的看法。儿科。 2012年10月；130(4):692-9 2. Grady C、Wiener L、Abdoler E、Trauernicht E、Zadeh S、Diekema D、Wilfond B、Wendler D。同意研究：青少年的声音。 青少年健康杂志 2014 年，54：515-520 3. Wiener L、Viola A、Wilfond B、Wendler D、Grady C。青少年研究参与者及其父母之间风险认知和财务补偿影响的对比观点。 人类研究伦理实证研究杂志，2015。10(1):49-58 4. Grady C、Nogues I、Wiener L、Wilfond B、Wendler D。青少年研究参与者对医学研究的描述。 AJOB 经验伦理学 2015。