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）：关于儿童同意研究参与的含义和要求的辩论渗透到生物伦理学，医学和心理学文献，但该领域的经验研究仍处于起步阶段。同意过程很重要 符合研究法规，但也可以用来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至关重要，尤其是在青春期和青春期期间，当儿童开始努力并获得更多决策独立性时。对儿童同意的先前研究是基于一个侧重于认知能力的模型。这项研究研究了儿童对研究要素的理解以及影响其理解的因素。儿童同意的第二个模型重点是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。关系模型并不关注谁做出决定，而是父母和孩子如何谈论它。它反映了这样的观点，即孩子可以以各种方式参与决策，而父母在孩子的成长中起着支持和建议的来源发挥重要作用。这项研究的主要目的是研究儿童参与有关临床试验入学的决策的好处，以及这些益处是否会根据儿童人群和社会心理特征而有所不同。换句话说，有些孩子比其他孩子从参与中受益更多吗？出于这项研究的目的，同意的潜在好处包括儿童对决策过程的公平性和他们的自我效能感的看法。拟议研究的假设是，成年人和儿童如何在研究决定上与儿童的自我效能相比，与最终做出决定更相关。这项创新的研究将在做出有关临床试验入学的实际决定后的10天内评估家庭，以治疗儿童的慢性病。研究 团队将测试儿童参与研究决策与公平性和自我效能感之间的关系（AIM 1），确定儿童参与与儿童同意之间的关系是否取决于儿童人口统计学和心理社会特征，例如年龄和感知的压力（AIM 2），以及在儿童参与者之间的关系（AIM 2），包括研究和研究人员的研究和研究人员的特征，包括和研究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有关的道德问题具有影响，并将导致开发干预措施和准则，以增强儿童参与研究决策的参与。 公共卫生相关性：何时以及如何让儿童参与研究参与的问题的问题一直是辩论的根源。该项目将研究同意过程的不同水平是否会影响儿童对决策过程公平性及其自我效能感的看法。这样的数据对于 了解研究人员和临床医生如何对个别儿童进行优化的同意 - 不仅要满足研究法规，而且还可以帮助儿童蓬勃发展。