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: 8242522
• 负责人: LAURA M. BESKOW
• 金额: $ 34.27万
• 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/8242522
• 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. PUBLIC HEALTH RELEVANCE: Many potentially high-impact research initiatives are significantly hindered by the limited availability of high- quality biospecimens and data. Ensuring that valid informed consent is obtained by accurately assessing and promoting comprehension is critical for protecting the rights and welfare of participants as well as preserving the integrity of research involving biobanking. The successful completion of the proposed study will lead to significant improvements in the way informed consent is conducted and evaluated for biobanking research.

描述（由申请人提供）：获得有效同意收集和存储生物样本和数据以供未来未指定的研究用途仍然是一个重大挑战。大量研究表明，包括生物样本库在内的各种环境下的研究参与者并不了解他们同意的研究的重要方面。为了解决这个问题，必须克服两个主要挑战。首先，对于什么构成生物样本库同意的“充分”理解尚未达成共识，这给何时获得有效同意带来了不确定性，并阻碍了设计和评估干预措施以提高理解的努力。其次，有关增强理解的干预措施效果的证据总体质量较差。先前的研究存在样本量小、非随机设计、与研究人群特征相关的局限性、如何定义和衡量“理解”的问题以及仅关注同意过程中选定的要素等问题。鉴于生物样本库研究的普遍性，迫切需要通过定义提供真正知情同意所需的知识门槛，并制定和严格研究干预措施以在完整的知情同意过程中促进理解来克服这些挑战。我们此应用程序的目标是开发和评估生物样本库的知情同意流程，其中涉及简化的同意书和交互式测试/反馈程序以增强理解。为了实现这一目标，我们将追求以下目标：（1）系统地确定证明充分的生物样本库同意理解所需的知识阈值； (2) 完善回授工具，以提高生物样本库同意过程中的理解力； (3) 进行一项全国性、多地点、随机试验，以确定回授干预和简化同意书对理解生物样本库同意书的个体和综合影响； (4) 探索回授干预和简化同意书对二次同意过程结果的单独和综合影响。预期成果包括系统开发的“充分”理解定义和高质量数据，证明改进形式和流程对生物样本库同意理解的影响，以及模型同意书、回授工具和可以轻松使用的措施适合在任何生物样本库环境中使用。 公共卫生相关性：许多潜在的高影响力研究计划都因高质量生物样本和数据的有限性而受到严重阻碍。确保通过准确评估和促进理解来获得有效的知情同意对于保护参与者的权利和福利以及维护涉及生物样本库的研究的完整性至关重要。拟议研究的成功完成将显着改善生物样本库研究的知情同意的进行和评估方式。