Examining how children benefit from the assent process for research decisions

检查儿童如何从研究决策的同意过程中受益

• 批准号: 8298761
• 负责人: Victoria Allison Miller
• 金额: $ 25.13万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-05 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8298761
• 关键词: Adolescence; Adult; Age; Area; Behavior; Benefits and Risks; Bioethics; Characteristics; Child; Child Development; Chronic; Clinical Trials; Cognitive; Data; Decision Making; Development; Elements; Empirical Research; Enrollment; Ethics; Family; Gatekeeping; Guidelines; Health; Healthcare; Individual; Lead; Literature; Medical Psychology; Medical Research; Modeling; Parent-Child Relations; Parents; Pattern; Perception; Play; Process; Regulation; Research; Research Personnel; Risk; Role; Sampling; Self Efficacy; Shapes; Source; Stress; Testing; base; decision research; experience; infancy; innovation; meetings; preference; psychosocial; therapy development

DESCRIPTION (provided by applicant): Debates about the meaning and requirements for child assent to research participation permeate the bioethics, medical, and psychology literatures, but empirical research in this area is in its infancy. The assent process is important for conforming to research regulations but can also be used to enhance children's sense of self- efficacy in health care settings. Optimizing children's roles in research decision making is critical, especially during pre-adolescence and adolescence, when children begin to strive for and acquire more decision making independence. Prior research on child assent has been based on a model that focuses on cognitive capabilities; this research examines children's understanding of the elements of research and the factors that influence their understanding. A second model of child assent focuses on the relational context of children's decision making. This model recognizes that decision making typically occurs in a family context and attends to the role of collaborative decision making in normative development. The relational model focuses not on who makes the decision, but on how parents and children talk about it. It reflects the view that children can be involved in decisions in various ways and that parents play an important role as sources of support and advice across the child's development. The primary objective of this research is to examine the benefits of children's involvement in decisions about clinical trial enrollment and whether these benefits vary based on child demographic and psychosocial characteristics. In other words, do some children benefit more from involvement than others? For the purpose of this research, the potential benefits of assent include children's perceptions of the fairness of the decision making process and their sense of self-efficacy. The assumption of the proposed research is that how adults and children interact about the research decision is more relevant for children's self-efficacy than who ultimately makes the decision. This innovative study will assess families within 10 days of having made an actual decision about clinical trial enrollment for the treatment of a chronic condition in the child. The research team will test the relationship between child involvement in the research decision and perception of fairness and self-efficacy (Aim 1), determine if the relationship between child involvement and the benefits of child assent depends on child demographic and psychosocial characteristics, such as age and perceived stress (Aim 2), and test the relationship between child involvement in the research decision and characteristics of the research, including perceived risks and benefits and research personnel behaviors (Aim 3). This research will provide data about children's actual involvement in research decisions and the factors that make their involvement more or less beneficial. Data from this project has implications for ethical questions related to child assent and will lead to the development of interventions and guidelines to enhance child involvement in research decision making. PUBLIC HEALTH RELEVANCE: The question of when and how to involve children in decisions about research participation has been a source of debate. This project will examine whether different levels of involvement in the assent process influence children's perceptions of the fairness of the decision making process and their sense of self-efficacy. Such data is critical for understanding how researchers and clinicians can optimize assent for individual children- not only so that research regulations are met, but also to help children flourish as a result of the assent process.

描述(申请人提供)：关于儿童同意参与研究的意义和要求的争论渗透在生命伦理学、医学和心理学文献中，但这一领域的实证研究还处于初级阶段。同意程序很重要 用于遵守研究规定，但也可用于增强儿童在卫生保健环境中的自我效能感。优化儿童在研究决策中的作用是至关重要的，特别是在青春期前和青春期，儿童开始争取和获得更多的决策独立性。以前关于儿童同意的研究一直基于一个侧重于认知能力的模型；这项研究考察了儿童对研究要素的理解以及影响他们理解的因素。儿童同意的第二种模式侧重于儿童决策的关系背景。该模型认识到决策通常发生在家庭背景下，并注意到协作决策在规范制定中的作用。关系模式关注的不是谁做决定，而是父母和孩子如何谈论这件事。它反映了这样一种观点，即儿童可以以各种方式参与决策，父母在整个儿童发展过程中发挥着重要的支持和建议来源的作用。这项研究的主要目的是检查儿童参与临床试验登记决策的好处，以及这些好处是否根据儿童的人口统计和心理社会特征而不同。换句话说，是不是有些孩子比其他孩子从参与中受益更多？在这项研究中，同意的潜在好处包括儿童对决策过程的公平性的感知和他们的自我效能感。这项研究的假设是，成人和儿童对研究决定的互动方式与儿童的自我效能感更相关，而不是最终由谁做出决定。这项创新的研究将在对儿童慢性病的临床试验登记做出实际决定后10天内对家庭进行评估。这项研究 研究小组将测试儿童参与研究决策与公平和自我效能感之间的关系(目标1)，确定儿童参与与儿童同意的益处之间的关系是否取决于儿童人口和心理社会特征，如年龄和感知到的压力(目标2)，并测试儿童参与研究决策与研究特征之间的关系，包括感知的风险和收益以及研究人员的行为(目标3)。这项研究将提供有关儿童实际参与研究决策的数据，以及使他们参与或多或少受益的因素。该项目的数据对与儿童同意有关的伦理问题有影响，并将导致制定干预措施和指导方针，以加强儿童参与研究决策。 公共卫生相关性：何时以及如何让儿童参与有关研究参与的决策一直是争论的来源。本项目将考察参与同意过程的不同程度是否影响儿童对决策过程的公平性的看法和他们的自我效能感。这些数据对于 了解研究人员和临床医生如何优化对个别儿童的同意--不仅是为了满足研究法规，也是为了帮助儿童在同意过程中茁壮成长。