ENHANCING THE BIOBANKING INFORMED CONSENT PROCESS TO IMPROVE COMPREHENSION

加强生物银行知情同意流程以提高理解力

• 批准号: 8529592
• 负责人: LAURA M. BESKOW
• 金额: $ 45.59万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-14 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8529592
• 关键词: Address; Back; Collection; Comprehension; Consensus; Consent; Consent Forms; Consult; Data; Data Quality; Educational process of instructing; Elements; Ensure; Ethics; Feedback; Future; Goals; Individual; Informed Consent; Intervention; Intervention Studies; Knowledge; Lead; Length; Measures; Modeling; Outcome; Participant; Population Study; Practice Guidelines; Procedures; Process; Randomized; Reading; Research; Rights; Sample Size; Social Welfare; Techniques; Testing; Time; Uncertainty; Work; biobank; design; experience; grasp; improved; intervention effect; prospective; randomized trial; satisfaction; study characteristics; tool

DESCRIPTION (provided by applicant): Obtaining valid consent for the collection and storage of biospecimens and data for future, unspecified research use remains a significant challenge. Numerous studies have documented that research participants in a variety of settings-including biobanking-do not understand important aspects of the research to which they consented. To correct this problem, two major challenges must be overcome. First, there is no consensus on what constitutes 'adequate' understanding in biobanking consent, creating uncertainty about when valid consent has been obtained and hampering efforts to devise and assess interventions to improve comprehension. Second, the overall quality of the evidence concerning the effects of interventions to enhance comprehension is poor. Prior studies have suffered from small sample sizes, non-randomized designs, limitations related to the characteristics of the study population, questions about how 'comprehension' was defined and measured, and a narrow focus on only selected elements of the consent process. Given the ubiquity of biobanking research, there is a critical need to overcome these challenges by defining the threshold of knowledge needed to provide truly informed consent, and developing and rigorously studying interventions to promote comprehension in the context of a complete informed consent process. Our objective for this application is to develop and assess an informed consent process for biobanking that involves a simplified consent form and an interactive test/feedback procedure to enhance comprehension. To achieve this objective, we will pursue the following aims: (1) Systematically determine the threshold of knowledge needed to demonstrate adequate biobanking consent comprehension; (2) Refine a teach-back tool to improve comprehension during the biobanking consent process; (3) Conduct a national, multisite, randomized trial to determine the individual and combined effects of a teach-back intervention and a simplified consent form on comprehension in biobanking consent; (4) Explore the individual and combined effects of a teach-back intervention and a simplified consent form on secondary consent process outcomes. The expected outcomes include a systematically-developed definition of 'adequate' understanding and high quality data demonstrating the effect of improvements to forms and processes on biobanking consent comprehension, as well as model consent forms, teach-back tools, and measures that could be readily adapted for use in any biobanking context.

描述（由申请人提供）：获得有效的同意书，以收集和存储生物测量和未来数据，未指定的研究使用仍然是一个重大挑战。许多研究表明，在各种环境中的研究参与者包括生物库，不了解他们同意的研究的重要方面。要纠正这个问题，必须克服两个主要的挑战。首先，关于生物库同意的“足够的”理解尚无共识，对何时获得有效同意的不确定性以及阻碍了设计和评估干预措施以提高理解的不确定性。其次，关于增强理解的干预措施影响的证据的总体质量很差。先前的研究遭受了较小的样本量，非随机设计，与研究人群特征相关的局限性，有关如何定义和测量“理解”的问题，以及仅关注同意过程的选定元素。鉴于生物群研究的普遍性，通过确定提供真正知情同意所需的知识的阈值，并在完整的知情同意过程中促进理解，以克服这些挑战，以克服这些挑战。我们对此应用的目的是开发和评估涉及简化同意书和交互式测试/反馈程序以增强理解的知情同意书。为了实现这一目标，我们将追求以下目的：（1）系统地确定证明足够的生物群体同意理解所需的知识阈值； （2）完善一种教学工具，以提高生物群体同意过程中的理解； （3）进行国家，多站点随机试验，以确定教学干预的个体和综合效果以及对生物库同意中理解的简化同意形式； （4）探讨教学干预措施的个体和综合效果以及对次级同意过程结果的简化同意书。预期的结果包括对“足够”理解和高质量数据的系统开发的定义，证明了对生物群体同意理解的形式和过程的改进以及模型同意书，教学表格工具以及可以随时适用于任何生物群体中使用的措施的影响。