Developing a Measure of Voluntary Consent for Protocol-Based Treatment Decisions

为基于协议的治疗决策制定自愿同意措施

• 批准号: 7147267
• 负责人: ROBERT M NELSON
• 金额: $ 17.57万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-01 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7147267
• 关键词: child rearing; children; choice; clinical research; coping; decision making; emotions; parents; preference

DESCRIPTION (provided by applicant): The individual choice to participate in research (i.e., consent) should be both informed and voluntary. The empirical study of consent has focused on the information (i.e., what a person knows) and decision-making aspects (i.e., how a person processes information) of consent. Few empirical studies examine the voluntary nature of consent, due largely to the lack of an instrument to measure "voluntariness." Absent such an instrument, it is difficult to distinguish between appropriate and "undue" influences on informed consent. Project Summary: The primary objective is to develop a valid and reliable measure of voluntary consent (called the "decision-making control instrument" or DMCI) for single-event decisions by parents concerning protocol-based treatment of their seriously ill child. A secondary objective is to explore relationships between the DMCI and other measures of decision-making preference, coping style and affect. The long-term objective is to extend the study of informed consent beyond the information and decision-making aspects to include the influence of affect, coping style and voluntary choice. The objectives will be met through four specific aims: (1) Item Generation: To create an item pool of measures that assesses all major dimensions of decision-making control for this sample of parents; (2) Scale Construction: To construct a voluntary consent scale (DMCI) appropriate for use with these parents; (3) Construct Validity: To examine the relationship between DMCI total score and selected measures of decision-making preference, coping style and affect; and (4) Pilot Testing: To administer the DMCI and conduct qualitative interviews with a second, smaller sample of parents to explore the instrument's ability to capture their own perceptions of the control they exercised over the single-event decision. This project advances the mission of the National Cancer Institute by enhancing our knowledge of the affective processes underlying single-event decisions concerning cancer treatment so that parents can make more informed and satisfying choices. Relevance: The assessment of whether consent is informed is becoming a part of many clinical trials. Absent a measure of voluntary consent, we are left with only a partial picture of the adequacy of the consent process. An instrument to assess the voluntary choice of a research participant will be an important addition to existing instruments so we may assess whether an individual's consent is both informed and voluntary.

描述（由申请人提供）：参与研究的个人选择（即同意）应该是知情和自愿的。关于同意的实证研究主要集中在同意的信息（即一个人知道什么）和决策方面（即一个人如何处理信息）。很少有实证研究考察同意的自愿性，这主要是因为缺乏衡量“自愿性”的工具。如果没有这样一项文书，就很难区分对知情同意的适当影响和“不适当”影响。项目摘要：主要目标是开发一种有效和可靠的自愿同意措施（称为“决策控制工具”或DMCI），用于父母就基于协议的重症儿童治疗方案做出的单一事件决策。第二个目标是探索DMCI与决策偏好、应对方式和情感等其他指标之间的关系。长期目标是将对知情同意的研究扩展到信息和决策方面以外，包括情感的影响、应对方式和自愿选择。目标将通过四个具体目标来实现：(1)项目生成：创建一个评估该家长样本决策控制的所有主要维度的措施项目库；(2)量表构建：构建适合这些家长使用的自愿同意量表（DMCI）；(3)建构效度：考察DMCI总分与决策偏好、应对方式和情绪的关系；(4)试点测试：对DMCI进行管理，并对第二个较小样本的父母进行定性访谈，以探索该工具捕捉他们对单一事件决策的控制的感知能力。这个项目推进了国家癌症研究所的使命，增强了我们对癌症治疗中单个事件决策背后的情感过程的了解，从而使父母能够做出更明智、更满意的选择。相关性：是否知情同意的评估正在成为许多临床试验的一部分。如果没有自愿同意的衡量标准，我们就只能对同意过程的充分性有部分了解。评估研究参与者自愿选择的工具将是对现有工具的重要补充，因此我们可以评估个人的同意是否既知情又自愿。