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（由申请人提供）：关于儿童同意参与研究的含义和要求的争论渗透到生物伦理学、医学和心理学文献中，但该领域的实证研究还处于起步阶段。同意过程很重要 符合研究规定，但也可用于增强儿童在医疗保健环境中的自我效能感。优化儿童在研究决策中的角色至关重要，尤其是在青春期前和青春期，此时儿童开始争取并获得更多的决策独立性。先前对儿童同意的研究是基于一个关注认知能力的模型。这项研究考察了儿童对研究要素的理解以及影响其理解的因素。儿童同意的第二种模型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环境中，并关注协作决策在规范发展中的作用。关系模型关注的不是谁做出决定，而是父母和孩子如何谈论它。它反映了这样一种观点，即儿童可以通过各种方式参与决策，而父母在儿童的发展过程中作为支持和建议的来源发挥着重要作用。这项研究的主要目的是检查儿童参与临床试验招募决策的好处，以及这些好处是否因儿童人口统计和社会心理特征而异。换句话说，是否有些孩子比其他孩子从参与中受益更多？就本研究而言，同意的潜在好处包括儿童对决策过程公平性的看法以及他们的自我效能感。拟议研究的假设是，成人和儿童如何就研究决策进行互动，与儿童的自我效能感比最终做出决定的人更相关。这项创新研究将在做出关于参加治疗儿童慢性病的临床试验的实际决定后 10 天内对家庭进行评估。研究 团队将测试儿童参与研究决策与公平感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好处之间的关系是否取决于儿童的人口统计和心理社会特征，例如年龄和感知压力（目标 2），并测试儿童参与研究决策与研究特征之间的关系，包括感知风险和收益以及研究人员行为（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的参与或多或少有益的因素。该项目的数据对与儿童同意相关的伦理问题具有影响，并将导致制定干预措施和指南，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研究参与决策的问题一直是争论的焦点。该项目将研究不同程度的参与同意过程是否会影响儿童对决策过程公平性的看法以及他们的自我效能感。此类数据对于 了解研究人员和临床医生如何优化个别儿童的同意——不仅满足研究规定，而且还可以帮助儿童在同意过程中蓬勃发展。