Sustainable Solutions to Translating Best Practices for Informed Consent

转化知情同意最佳实践的可持续解决方案

• 批准号: 10797479
• 负责人: MARY C POLITI
• 金额: $ 40万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10797479
• 关键词: Sustainable; Solutions; Translating; Best; Practices

Project Summary/Abstract Current approaches to informed consent hinder rather than help research recruitment. Informed consent templates often include legal jargon, technical wording, and numerous repetitive and confusing sections. The consent process and templates can increase disparities in study participation among racially minoritized populations, rural-residing populations and older adults. Fortunately, we and colleagues have developed tools and recommendations to improve understanding and adoption of evidence-informed practices for consent in clinical trials. Yet these tools and recommendations are not widely used in practice. In this project, we will used mixed-methods to address this gap between knowledge and practice. We aim to: (1) Engage with key stakeholders to improve these forms and processes in a way that is feasible, acceptable, and sustainable; (2) Prepare an improved consent template and process for implementation; (3) Implement and test the consent template and process in three studies (1 per institution at 3 institutions). We will use Expert Recommendations for Implementing Change (ERIC) strategies to ready sites for implementation, focusing on strategies to increase capability, opportunity, and motivation to implement change. A community advisory board will actively engage in the study for its duration to ensure that each step of the process aligns with their needs. Our strong study team has expertise in research ethics, health literacy, health communication, health decision making and implementation science. This study will overcome barriers to translation by providing: (1) A toolkit to facilitate adoption of an evidence-based informed consent template and process, and (2) a national model for participant-centered informed consent, meeting regulatory requirements without overburdening participants or researchers. We will test our intervention’s robustness in different environments with different regulatory systems for research and unique institutional strengths.

项目总结/摘要 目前的知情同意方法阻碍而不是帮助研究招募。知情同意 模板通常包括法律的行话、技术措辞以及大量重复和混淆的部分。的 同意过程和模板可能会增加种族少数群体参与研究的差异 人口、农村居民和老年人。幸运的是，我们和同事已经开发出了 和建议，以更好地理解和采用知情同意的循证做法， 临床试验然而，这些工具和建议在实践中并没有得到广泛应用。在这个项目中，我们将使用 混合方法来解决知识和实践之间的差距。我们的目标是：（1）与关键 利益相关者以可行、可接受和可持续的方式改进这些形式和过程;（2） 准备改进的同意模板和实施流程;（3）实施和测试同意 三项研究的模板和流程（3个机构，每个机构1个）。我们将使用专家建议 实施变革（ERIC）战略，为实施做好准备，重点是 提高实施变革能力、机会和动力。社区咨询委员会将积极 参与研究，以确保过程的每一步都符合他们的需求。我们强大 研究团队在研究伦理、健康素养、健康传播、健康决策和 执行科学。本研究将克服翻译的障碍，提供：（1）一个工具包，以促进 通过一个基于证据的知情同意模板和程序，以及（2）国家模式， 以受试者为中心的知情同意，满足监管要求，而不会给受试者带来过重负担，或 研究人员我们将测试我们的干预措施在不同监管环境下的稳健性。 研究系统和独特的机构优势。